BridgeBio and Helsinn’s Truseltiq (infigratinib) Receive the US FDA’s Approval for Cholangiocarcinoma
Shots: The approval is based on a P-II study assessing Truseltiq (125mg, qd, for 21 days of 28-day cycles) in 108 patients who had undergone […]
Shots: The approval is based on a P-II study assessing Truseltiq (125mg, qd, for 21 days of 28-day cycles) in 108 patients who had undergone […]
Shots: The approval is based on a P-III study assessing Comirnaty (two 30μg doses) in 2,260 participants aged 12-15yrs. and showed 100% efficacy in participants […]
Shots: The approval is based on the CodeBreaK 100 trial evaluating the efficacy & tolerability of Lumakras (960mg, qd) in 124 patients with KRAS G12C […]
Shots: EMA’s COMP has granted ODD to SLS-005 for the treatment of amyotrophic lateral sclerosis Under ODD, Seelos will get benefit from several incentives such […]
Shots: EMDAC has voted 10-7, confirming that the benefits of teplizumab outweigh the risks supporting the approval to delay T1D Mellitus The recommendation is based […]
Shots: The approval is based on P-III ADAURA trial assessing Tagrisso (80mg, qd, PO) vs PBO in 682 patients with stage IB, II, IIIA EGFRm […]
Shots: The approval is based on a P-III True North trial assess Zeposia (0.92 mg) vs PBO in an adult with mod. to sev. active […]
Shots: The approval is based on P-III CheckMate -743 study assessing Opdivo + Yervoy vs SOC Pt. based CT in patients with previously untreated unresectable […]
Shots: Eli Lilly and Dicerna have reported the US FDA’s IND acceptance of LY3819469 to treat cardiometabolic diseases. The IND acceptance triggers $10M as a […]
Shots: The approval is based on efficacy and safety data from the P-III LIBERTY 1 & 2 studies assessing Myfembree (relugolix 40 mg, estradiol 1 […]
Shots: The US FDA has granted EUA for sotrovimab for mild to mod. COVID-19 patients aged ≥12yrs. who are at high risk for progression to […]
Shots: The BLA submission is based on P-III UNITY-CLL trial evaluating ublituximab + Ukoniq (U2) vs obinutuzumab + chlorambucil in a ratio (1:1) in 420 […]
Shots: The approval is based on P-III VIALE-A and P-Ib M14-358 studies. The P-III study involves assessing Venclyxto + azacitidine in patients with newly diagnosed […]
Shots: The BTD is based on P-II 1346.9 clinical trial, which demonstrated that BI 425809 improved cognition in adult patients with schizophrenia Moreover, the company […]
Shots: The NDA submission is based on P-I study of adult patients, the P-II NAVIGATE trial in adult and adolescent patients and the P- I/II […]
Shots: The CHMP recommended the approval of Libtayo as a 1L treatment for adults with NSCLC expressing PD-L1 in ≥50% of tumor cells with no […]
Shots: The US FDA has granted accelerated approval which is based on P-I CHRYSALIS study assessing Rybrevant as a monothx. in patients metastatic non-small cell […]
Shots: The opinion is based on P-II CheckMate -142 study assessing Opdivo + Yervoy in patients with mismatch repair deficient or microsatellite instability–high metastatic colorectal […]
Shots: The NDA is based on P-III TAK-620-303 (SOLSTICE) trial assessing Maribavir vs IAT in HCT and SOT recipients with CMV infection refractory, with/ out […]
Shots: MHLW has granted EUA for Vaxzevria (ChAdOx1-S [Recombinant]) for active immunization of individuals aged ≥18yrs. to prevent COVID-19. The EUA is based on P-III […]
Shots: MHLW has granted special approval under article 14-3 of the PMDA for emergency use of Moderna’s mRNA COVID-19 vaccine based on Takeda’s P-I/II immunogenicity […]
Shots: The NDA submission is based on P-III studies (SERENITY I & II) assessing BXCL501 (120 & 180mcg doses) vs PBO for the acute treatment […]
Shots: Roche’s cobas SARS-CoV-2 test to be use on high-throughput cobas 6800/8800 systems has received the US FDA’s EUA for testing individuals without symptoms or […]
Shots: The submission is based on a P-III ORIENT-11 study assessing sintilimab (200mg) + pemetrexed and platinum CT vs PBO + CT as a 1L […]
Shots: Abbott has received CE Mark for Navitor making the minimally invasive device available for people in Europe with severe aortic stenosis who are at […]
Shots: The approval is based on P-III head-to-head PEGASUS study assessing Empavel vs Soliris (eculizumab) in 80 adults with PNH. Participants should be Soliris stable […]
Shots: The US FDA approved Zynrelef (bupivacaine and meloxicam) extended-release solution for postsurgical analgesia in patients with soft tissue or periarticular instillation for 72 hrs […]
Shots: The US FDA has granted FTD to losmapimod for the treatment of FSHD while the therapy has previously received ODD for FSHD The company […]
Shots: The NMPA has approved the IND application for the P- III SIENDO trial to evaluate the safety and efficacy of selinexor for advanced or […]
Shots: The approval is based on data from an extensive development program that consists of four P-III clinical trials evaluating Qelbree in 1000+ pediatric patients […]
Shots: The submission is based on PATHFINDER clinical program including P-III NAVIGATOR that involves assessing Tezepelumab + SOC vs PBO + SOC in 1061 adults […]
Shots: The FDA has expanded the EUA for Pfizer’s COVID-19 vaccine in adolescents based on the data from the P- III trial in 2,260 participants […]
The EMA has begun a rolling review of a COVID-19 antibody developed by GlaxoSmithKline and Vir BioTech which could become the fourth drug of its […]
Shots: The rolling review will assess sotrovimab in adults and adolescents (aged 12yrs.) with COVID-19 who do not require oxygen supplementation and who are at […]
Shots: The 1st sNDA and sBLA is based on results from the P-III CLEAR Study evaluating Lenvima + Keytruda or in combination with everolimus vs […]
Shots: The acceptance is based on a P-III ADVANCE trial assessing the efficacy of Otezla (30 mg, bid) vs PBO in 595 patients in a […]
Shots: The MAA is based on a P-III BLISS-LN study assessing the efficacy and safety of belimumab (10 mg/kg, IV) + standard therapy vs PBO […]
Shots: The approval is based on P-III IMpower110 study assessing the efficacy and safety of Tecentriq vs CT in 572 PD-L1-selected, CT-naïve participants in a […]
Shots: The approval is based on P-III DAPA-CKD trial assessing Farxiga (qd, 10 mg) + SOC vs PBO in 4304 patients with CKD stages 2-4 […]
Shots: The filing is based on results from the P-III CheckMate -274 trial evaluating Opdivo (240mg, q2w for up to 1 yrs.) vs PBO in […]
Shots: The application is based on P-Ib/II CARTITUDE-1 study evaluating cilta-cel in adults with r/r MM who have received at least prior 3L therapies across […]
Shots: The company has submitted MAA for Omburtamab to EMA for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma The company continues to […]
Shots: The US FDA has granted PR for mobocertinib’s NDA to treat adult patients with EGFR Exon20 insertion+ mNSCLC, as detected by an FDA-approved test, […]
Shots: Glenmark is concluding the final, national phase of its MAA process to enable launch of its innovative nasal spray, Ryaltris (olopatadine hydrochloride, 665mcg and […]
Shots: The recommendation is based P-III ADAURA trial assessing Tagrisso (80mg, qd, PO) vs PBO in 682 patients with stage IB, II, IIIA EGFRm NSCLC […]
Shots: EMA’s CHMP has recommended conditional marketing authorization of Selumetinib in the EU. The recommendation is based on the results from the P-I/II SPRINT Stratum […]
Shots: The EC has granted conditional approval for Jemperli in women with dMMR/ MSI-H endometrial cancer that has progressed on or following prior treatment with […]
Shots: The CHMP has recommended the approval of Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L treatment for unresectable MPM and is based P-III CheckMate -743 […]
Shots: The submission is based on P-IIb/III SELECTION study evaluating the efficacy and safety of filgotinib (200mg, qd) vs PBO in patients with mod. to […]
Shots: The approval is based on P-III ENVISION I study that involves assessing the efficacy, safety, and PK of Humira (SC) in pediatric patients aged […]
Shots: The US FDA has approved the BLA filing for Jemperli for adult patients with dMMR recurrent or advanced solid tumors endometrial cancer, as determined […]
Shots: The US FDA has approved Ventana MMR RxDx panel to identify endometrial cancer patients who are eligible for treatment with GSK’s Jemperli (monothx.) that […]
Shots: The US FDA has granted FT Designation to LX1001 for the treatment of APOE4 associated AD. The designation evaluates to facilitate the development and […]
Shots: The approval is based on P-III study evaluating cannabidiol (25 mg/kg/day) vs PBO in patients aged ≥2yrs. as an adjunctive treatment of seizures associated […]
Shots: The approval is based on results from the P-III ANDROMEDA (AMY3001) study involves assessing the safety and efficacy of Darzalex (1800mg, SC, qw) + […]
Shots: The first sBLA is based on the P-III EV-301 trial assessing Padcev vs CT in ~ 600 patients with LA or mUC prior treated […]
Shots: The approval is based on data from the P-III IKEMA study evaluating Sarclisa + carfilzomib and dexamethasone (Kd) vs Kd alone in 302 patients […]
Shots: The approval is based on two studies i.e. FIREFISH & SUNFISH. The FIREFISH study involves assessing Evrysdi in infants aged 2-7mos. with symptomatic Type […]
Shots: The approval is based on P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced or […]
Shots: The approval is based on results from the P-III ADAURA trial assessing Tagrisso (80mg, qd) vs PBO in 682 patients with stage IB, II, […]
Shots: The US FDA has approved the sBLA for a new self-administration option for Xolair in patients across all approved indications in the US The […]
Shots: The P-III CheckMate -648 trial involves assessing Opdivo (nivolumab) + CT or Opdivo (3 mg/kg, q2w) + Yervoy (1 mg/kg, q6w up to 24mos.) […]
Shots: The submission is based on two P-III studies KEEPsAKE-1 & -2 studies involves assessing Skyrizi (150mg) vs PBO in adult patients with active PsA […]
Shots: The EC’s approval is based on data from DELIVER and REFINE studies evaluating the efficacy, PK, and PD of Tysabri (300mg, SC, q4w) vs […]
Shots: Lilly and Incyte reported that the US FDA has extended the review period of sNDA for baricitinib to treat adults with mod. to sev. […]
Shots: The EC has granted ODD for PBKR03 for the treatment of Krabbe disease. The ODD was based on an EMA’s COMP positive opinion The […]
Shots: The US FDA has accepted IND to assess the safety, tolerability, PK, and preliminary antitumor activity of XB002 in patients with advanced solid tumors. […]
Shots: The designation is based on efficacy & safety results from the P-II FOENIX-CCA2 study involves assessing futibatinib (TAS-120) in patients with advanced cholangiocarcinoma. The […]
Shots: The approval is based on P-III study involves assessing Taltz (20mg for <25kg/40mg for 25-50kg/80 mg for >50 kg @12wks., with 40/80/160mg starting doses, […]
Shots: The sBLA is based on data from the P- I/II ZUMA-3 trial in adult patients age ≥18 years old for the treatment of adult […]
Shots: The NDA submission is based on data from P-III PROTECTIVE-2 study evaluating Plinabulin + Neulasta vs Neulasta alone for the prevention of CIN The […]
Shots: The approval is based on P-III IKEMA study involves assessing of Sarclisa + carfilzomib and dexamethasone(kd) vs SOC in 302 patients with RRMM who […]
Shots: The approval is based on P-III ASCLEPIOS I and II studies that involve assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, PO, qd) in […]
Shots: The approval is based on clinical data from the Harmony TPV clinical study that showed freedom from mortality & acceptable hemodynamic function @30days & […]
Shots: The approval is based on two studies i.e. FIREFISH and SUNFISH. The FIREFISH study involves assessing Evrysdi in infants aged 2-7mos. with symptomatic Type […]
Shots: The CHMP’s recommendation is based on Phase III IMpower110 study assessing Tecentriq vs CT in 572 PD-L1-selected, CT-naïve participants in a ratio (1:1) with […]
Shots: The EUA submission is based on an interim analysis of the P-III COMET-ICE study assessing VIR-7831 vs PBO for the early treatment of COVID-19 […]
Shots: The approval is based on two clinical studies and a retrospective analysis of RWD. The device is intended to be used by prescription only […]
Shots: EMA’s CHMP has adopted a positive opinion recommending the use of Benlysta (IV, SC) in combination with background immunosuppressive therapies for the treatment of […]
Shots: The approval is based on the P-II KarMMa trial that involves assessing Abecma in 127 patients with r/r MM prior treated with 3L+ therapy […]
Shots: The MAA is based on the P-III EV-301 trial which involves assessing Enfortumab Vedotin vs CT in ~ 600 patients with LA/m-UC, prior treated […]
Shots: The submission is based on a P-III TIDES trial assessing TAK-003 (0.5ml, SC) vs PBO in 20,000+ healthy children & adolescents aged 4-16yrs. to […]
Shots: The MHLW has approved Acuvue Theravision with Ketotifen as the first combination contact lens that provides vision correction and an antihistamine drug to relieve […]
Shots: The approval is based on results from P- Ib/II GO29365 study assessing Polivy (IV, 30 & 140mg) + BR vs BR alone in 80 […]
Shots: The approval is based on the P-III NAVIGATE trial in adult and adolescent patients and P- I/II pediatric SCOUT trial involves assessing Vitrakvi for […]
Shots: The approval is based on the P-II FIGHT-202 study that involves assessing Pemazyre (13.5mg, qd, on a 21-day cycle) in adults aged ≥18yrs. with […]
Shots: The approval is based on efficacy results from P-III studies involve assessing Zegalogue vs PBO in children aged 6-17yrs. and in adults with T1D […]
Shots: The US FDA has issued refusal to file a letter covering the label expansion application for semaglutide (2.0mg/qw) for T2D, which was submitted on […]
Over a year has gone by since the beginning of the global pandemic, and it’s clear that the pharmaceutical industry and COVID-19 vaccines are at […]
Shots: The approval is based on the P-III RHAPSODY trial involves assessing Arcalyst (SC, qw, 300mg followed by 160mg) vs PBO in adults and children […]
Shots: The approval is based on the P-III RHAPSODY trial involves assessing Arcalyst (SC, qw, 300mg followed by 160mg) vs PBO in adults and children […]
Shots: The approval is based on P-III KEYNOTE-204 study assessing Keytruda (200mg, IV, q3w) vs BV (1.8 mg/kg, IV, q3w) in 304 patients in a […]
Shots: The approval is based on P-III KEYNOTE-204 study assessing Keytruda (200mg, IV, q3w) vs BV (1.8 mg/kg, IV, q3w) in 304 patients in a […]
Shots: The NDA is based on P-II study-004 trial involves assessing Belzutifan (120 mg, PO, qd) in 61 patients with VHL disease who had at […]
Shots: The BTD is based on a P-Ib/II TRANQUILITY study assessing BXCL501 in patients with acute treatment of agitation associated with dementia, including AD The […]
Shots: The submission is based on P-III HELP study evaluating lanadelumab (300mg, q2w & q4w) vs PBO in 125 patients with HAE attack for 26wks. […]
Shots: The submission is based on P-III HELP study evaluating lanadelumab (300mg, q2w & q4w) vs PBO in 125 patients with HAE attack for 26wks. […]
Shots: The submission is based on EV-301 and EV-201 trials in Japan. The P-III EV-301 trial assessing Enfortumab Vedotin vs CT in ~ 600 patients […]
Shots: The US FDA has granted FTD for VX-880 to treat T1D. The designation is designed to facilitate the development and expedite the review of […]
Shots: The US FDA has granted approval of Ventana ALK (D5F3) as a CDx assay to identify ALK+ NSCLC patients eligible for treatment with Pfizer’s […]
Shots: The approval is based on a P-II ZUMA-5 study assessing Yescarta (axicabtagene ciloleucel) in 146 patients aged ≥18rs. with r/r iNHL, prior treated with […]
Shots: The company reported the voluntary withdrawal of the Tecentriq (atezolizumab) indication in the US for prior-platinum treated mUC, bladder cancer The withdrawal was made […]
Shots: Takeda has submitted an NDA to MHLW to import and distribute Moderna’s (mRNA-1273/ TAK-919) in Japan Takeda is conducting a P- I/II study assessing […]
Shots: The approval is based on P-III focuSSced trial assessing Actemra (SC, 162mg) vs PBO in a ratio (1:1) in 212 adults with SSc. The […]
Shots: The sBLA is based on P-III study assessing Dupixent + SOC maintenance therapy in children aged 6-11yrs. with moderate-to-severe asthma with type 2 inflammation […]
Shots: The approval is based on P-III CROWN study assessing Lorbrena vs Xalkori (crizotinib) monthx in 296 people in a ratio (1:1) with prior untreated […]
Shots: The approval is based on a P-III APSEN study involve assessing Brukinsa vs ibrutinib in 201 patients with r/r or TN WM who harbor […]
Shots: The NDA submission is based on two P-III studies (COUGH-1 & -2) involves assessing gefapixant (45/15mg, bid) vs PBO in 2,044 patients with RCC […]
Shots: The CHMP recommendation is based on P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced […]
Shots: The EMA’s CHMP has recommended the use of casirivimab + imdevimab in patients with confirmed COVID-19 who do not require oxygen supplementation and who […]
Shots: The FDA has issued a EUA for a single-shot COVID-19 vaccine to prevent COVID-19 in individuals aged ≥18yrs. The company plans to file BLA […]
Shots: The FDA has approved Nulibry based on three clinical trials compared to data from a natural history study in patients with MoCD Type A […]
Shots: Regeneron reported changes to the P-III study assessing REGEN-COV in non-hospitalized patients with COVID-19, following recommendations from the IDMC The IDMC found clear clinical […]
Shots: The approval is based on P-III ENVISION I study that involves assessing Humira (SC) vs PBO in pediatric patients aged 4-17yrs. with mod. to […]
Shots: The US FDA has accepted the PR of BLA for TicoVac to prevent TBE in patients aged ≥1year with an anticipated PDUFA date in […]
Shots: Health Canada has approved Dupixent for the treatment of mod. to sev. AD in children aged 6 to 11yrs. whose disease is not adequately […]
The life sciences industry will move toward more agile capabilities for regulatory operations and regulators toward an accelerated approval pathway in support of clinical studies, […]
Shots: The sNDA filing is based on P-III ADVANCE trial data, assessing Otezla (30 mg, bid) vs PBO in 595 patients in a ratio (1:1) […]
Shots: The sNDA submission is based on the P-III REACH3 study assessing ruxolitinib vs best available therapy in adult and pediatric patients ≥12yrs. with steroid-refractory […]
Shots: The approval is based on the P-III EMPOWER-Lung 1 trial assessing Libtayo (350mg, q3w) monothx. vs platinum doublet CT in 710 patients for the […]
Shots: The company reported the voluntary withdrawal of the Imfinzi (durvalumab) indication in the US for prior treated adult patients with LA or metastatic bladder […]
Shots: The NDA is based on two P-III TRuE-AD 1 & 2 assessing ruxolitinib cream (0.75%/1.5%, bid) vs vehicle (non-medicated cream) in 600 patients aged […]
Shots: The US FDA has granted BTD to the tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with unresectable/ mUM The pre-planned interim analysis […]
Shots: The first BLA submission is based on P-III EV-301 trial which involves assessing of Padcev vs CT in 600 patients with locally advanced or […]
Shots: The FDA has approved Patient-Specific Talus Spacer 3D-printed talus implant for humanitarian use. The FDA reviewed data through the HDE process Data supporting the […]
Shots: The sDNA submission is based on a P-III APSEN study assessing Brukinsa vs ibrutinib in 351 patients with WM and includes a pivotal P-II […]
Shots: The approval is based on P-III PARAGON-HF study involves assessing of Entresto (sacubitril/valsartan) in the treatment of patients with preserved ejection fraction HFpEF The […]
Shots: The approval is based on P-III MEDALIST study involves assessing ReblozyL vs PBO in a ratio (2:1) in adult patients with very low- to […]
Shots: WHO has granted EUL to AZ’s vaccine for active immunization to prevent COVID-19 in individuals aged ≥18yrs., including those over 65yrs. EUL granted AZ […]
Shots: The US FDA has granted FT designation for ONCOS-102 based on pre/clinical efficacy associated with broad immune activation observed to date The designation is […]
Shots: The P-III CLEAR study involves assessing of Lenvima (20 mg/day) + Keytruda (200 mg, IV, q3w) or in combination with everolimus (5mg, qd) vs […]
Shots: The approval is based on the P-III study that involves assessing Panzyga (IVIg) in 142 patients with CIDP. The study evaluated more than one […]
Shots: The approval is based on three clinical trials involves assessing Trilaciclib +carboplatin/etoposide (+/- atezolizumab) and topotecan CT regimens in patients with ES-SCLC. 90% of […]
Shots: The approval is based on P-III ELIPSE trial that involves assessing Evkeeza (15 mg/kg, IV, q4w) + vs PBO in 65 patients aged ≥12yrs. […]
Shots: The EC granted ODD for VO659 for the treatment of spinocerebellar ataxia (SCA). The ODD was based on a EMA’s COMP positive opinion The […]
Shots: The FDA authorized EUA for bamlanivimab (700 mg) and etesevimab (1400 mg) for the treatment of mild to mod. COVID-19 patients aged ≥12yrs. who […]
Shots: The FDA approval is based on P-II trial involves assessing Libtayo (350mg, q3w) in patients with locally advanced BCC & metastatic BCC (nodal or […]
Shots: NMPA has granted BTD to socazolimab for cervical cancer. Socazolimab is licensed from Sorrento to COF for the greater China territory Lee intends to […]
Shots: The EC approval is based on JAKARTA and JAKARTA2 studies. The pivotal JAKARTA study involves assessing Inrebic (500mg) vs PBO in 289 patients with […]
Shots: The MAA is based on P-III BRIGHTE study assessing Rukobia (600mg, bid) + OBT vs PBO in 371 HTE adults living with multidrug-resistant HIV. […]
Shots: The approval is based on pivotal TRANSCEND NHL 001 (017001) study assessing Breyanzi in 268 patients with 3L+R/R LBCL including patients with a broad […]
Shots: The EUA submission is based on P-III ENSEMBLE trial assessing the safety and efficacy of the COVID-19 vaccine in protecting adults aged ≥18yrs. against […]
Shots: The approval is based on P-III DAPA-HF trial involves assessing of Forxiga (10mg, qd) + SOC (ACEi or ARB) vs PBO + SOC in […]
Shots: The approval was based on P-III ADMIRAL assessing gilteritinib (120mg, qd) vs CT in 319 patients with relapsed or refractory AML. The study showed […]
Shots: The approval is based on pivotal P- II VISION study that involves assessing of Tepmetko (450mg, qd) as monothx. in 152 patients with a […]
Shots: The approval follows P-III ORIENT-11 study assessing Tyvyt (sintilimab) vs PBO + Almita (pemetrexed) and platinum CT in 397 participants in a ratio (2:1) […]
Shots: The MAA submission is based on a P-Ib/II CARTITUDE-1 study assessing the safety and efficacy of cilta-cel in adults with r/r MM. The company […]
Shots: The EMA’s CHMP has adopted a positive opinion of pemigatinib for the treatment of adults with unresectable locally advanced or metastatic cholangiocarcinoma with documented […]
Shots: The US FDA has granted FTD for GLR2007 for the treatment of patients with glioblastoma and application is eligible for Rolling Review and for […]
Shots: The BT designation is based on P-II CodeBreaK 100 study assessing Sotorasib in 126 patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who […]
Shots: The EMA’s CHMP accepted a positive opinion for the use of Sogroya (somapacitan), once-weekly recommending its approval for the treatment of adults with growth […]
Shots: The approval is based on data from three pivotal clinical trials P-II SELECT-PsA 1& 2 and P-II/III SELECT-AXIS 1 involves assessing of Rinvoq in […]
Shots: The approval is based on pivotal P-III KEYNOTE-177 study involves assessing of Keytruda (200mg, q3w) vs CT regimen in 307 patients in a ratio […]
Shots: Cardiff University will receive milestone payments that advance from the discovery collaboration into clinical development and royalty payments on sales of any products that […]
Shots: The BLA submission is based on P-II POD1UM-202 trial involves assessing of retifanlimab (500 mg, q4w) in 94 patients with locally advanced or metastatic […]
Shots: The companies sign a purchase agreement with Covax to supply 40M doses of the COVID-19 vaccine. First deliveries are expected in Q1’ 2021, subject […]
Shots: The companies sign a purchase agreement with Covax to supply 40M doses of the COVID-19 vaccine. First deliveries are expected in Q1’ 2021, subject […]
Shots: The approval is based on the pivotal AURORA P-III study and AURA-LV P-II study involves assessing of Lupkynis + SoC in 533 patients to […]
Shots: Rhinostics plans to register the P&G polypropylene nasal swab as a Class I Exempt medical device and will pursue Emergency Use Authorization for home […]
Shots: The approval is based on results from CheckMate -9ER, P-III pivotal trial involves assessing of Cabometyx + Opdivo vs sunitinib in 651 patients previously […]
Shots: The approval is based on P-II Brigatinib-2001 (J-ALTA) assessing Alunbrig in 72 Japanese patients with ALK+ NSCLC and P-III AP26113-13-301 (ALTA-1L) study assessing Alunbrig […]
Shots: The approval is based on pivotal phase III ATLAS and FLAIR study assessing Cabenuva in 1,100+ HIV-1 adults to replace the current ARV regimen […]
Shots: The approval is based on SUSTAIN FORTE trial assessing Ozempic (2.0mg, qw) vs Ozempic (1.0mg) in 961 people with T2D in need of treatment […]
Shots: The sNDA submission is based on a P-II study that involves assessing Esbriet vs PBO in patients aged ≥18-85yrs. with progressive fibrosing UILD for […]
Shots: The approval is based on pivotal P-III VICTORIA trial involves assessing of Verquvo (2.5mg, 5mg & 10mg) vs PBO in 5,050 adult patients with […]
Shots: The approval is based on pivotal P-II DESTINY-Breast01 study involves assessing of Enhertu (5.4 mg/kg) in 184 patients as a monothx. for patients with […]
Shots: The US FDA has accepted the BLA and granted the PR with an anticipated PDUFA date as Jul 17, 2021 The BLA filing marks […]
Shots: The PRIME designation is based on two Phase I/II studies in R/R cHL conducted at Baylor College of Medicine and the University of North […]
Shots: The approval is based on P-III ANDROMEDA (AMY3001) study involves assessing of Darzalex Faspro + bortezomib, cyclophosphamide, and dexamethasone (VCd) vs VCd alone in […]
Shots: The approval is based on pivotal P-II DESTINY-Gastric01 trial involves assessing of Enhertu (6.4 mg/kg, q3w) vs CT in a ratio (2:1) in adult […]
Shots: Imfinzi has been approved in the EU and the UK for an additional dosing option (1500mg, fd, q4w) in LA, unresectable NSCLC in adults […]
Shots: The US FDA has granted BTD for Ligelizumab for the treatment of CSU in patients with an inadequate response to H1-antihistamine treatment The therapy […]
Shots: Henlius reported that NMPA has approved the IND application of HLX15 for the treatment of multiple myeloma The company has compared HLX15 in a […]
Shots: The approval is based on the ADVL0912 study assessing Xalkori in 121 patients aged 1-21yrs. that included 26 patients with r/r, systemic ALK+ ALCL […]
Shots: The approval is based on Tislelizumab + CT regimen vs CT as monothx. in 360 patients with a ratio (1:1:1) as a 1L for […]
Shots: The approval is based on P1093 & ODYSSEY (Penta20) studies assessing safety, tolerability & dose-finding of Tivicay (5mg) in pediatric patients aged 4wks.-18yrs. while […]
Shots: Bayer Reports the US FDA’s Acceptance of NDA and Grants Priority Review for Finerenone (BAY 94-8862) to Treat CKD and T2D The US FDA […]
Shots: The approval follows P-III trials (PROMISE-1 in episodic migraine & PROMISE-2 in chronic migraine) assessing Vyepti vs PBO in 2,076 adult patients for the […]
Shots: The EC has approved Xofluza (baloxavir marboxil) for uncomplicated influenza in patients aged≥12yrs. Additionally, the EC has approved Xofluza for post-exposure prophylaxis of influenza […]
Shots: The US FDA has accepted the PR for NDA of mirabegron (oral suspension) and sNDA for Myrbetriq (mirabegron, tablets) for neurogenic detrusor overactivity (NDO) […]
Shots: The acceptance of regulatory submission and the granting of PR is based on P-III DAPA-CKD study assessing Farxiga (10mg, qd) + SOC vs PBO […]
Shots: The BTD is based on P-II CITYSCAPE study assessing Tiragolumab + Tecentriq vs Tecentriq + PBO as a 1L treatment of 135 patients in […]
Shots: The BLA submission is based on P-lll study assessing the safety and efficacy of Somatrogon (0.66 mg/kg, qw) vs Somatropin (0.034 mg/kg, qd) in […]
Shots: The BLA for teplizumab to delay or prevention of clinical T1D in at-risk individuals has been filed to the US FDA. The FDA has […]
Shots: The NDA is based on STORM and SADAL studies. The P-IIb STORM study involves assessing of ATG-010 + low-dose dexamethasone in patients with rrMM […]
Shots: India has granted the emergency use approval for AstraZeneca and the Oxford University’s COVID-19 vaccine developed by a day after an advisory panel of […]
Shots: Health Canada expedite the review of AstraZeneca’s COVID-19 vaccine after the vaccine received the UK’s MHRA approval for emergency use Following an agreement to […]
Shots. The company has submitted MAA to COFEPRIS (the health regulatory authority for Mexico) for its COVI-STIX rapid diagnostic test to detect SARS-CoV-2 virus nucleocapsid […]
Shots: Vertex’ new drug submission for Trikafta has been accepted for Priority Review by Health Canada for the treatment of CF in people aged ≥12yrs. […]
Shots: The company reported that the COVID-19 vaccine is safe, well-tolerated & immunogenic in the P-I/II study & plans to initiate P-III clinical trial in […]
Shots: The MHRA has provided authorization for an emergency supply of AZD1222, for the active immunization of individuals aged ≥18yrs. The approval recommends 2 doses […]
Shots: The submission is based on SUSTAIN FORTE trial assessing Ozempic (2.0mg, qw) vs Ozempic (1.0mg) in 961 people with T2D in need of treatment […]
Shots: Chi-Med initiated the filing of NDA to the US FDA for surufatinib to treat pancreatic & non-pancreatic NET & plans to complete the NDA […]
Shots: The BT (breakthrough therapy) Designation was based on initial data for ongoing single-arm, open-label, non-randomized, dose-escalation, P-I study for safety and efficacy in B-ALL […]
Shots: The US FDA has granted orphan drug designation for AP103 for the treatment of DEB Amyrt licensed a pre-clinical gene – therapy platform technology […]
Shots: The NMPA has approved Byvasda for the treatment of adult recurrent Glioblastoma which is the third approved indication of Byvasda in China The launch […]
Shots: The approval is based on P-III FeDeriCa study evaluating the pharmacokinetics, efficacy, and safety of Phesgo + CT vs Perjeta + Herceptin (IV) + […]
Shots: Janssen Initiates Rolling Submission of BLA to US FDA is based on P-lb/ll CARTITUDE-1 Study involve evaluating the safety and efficacy of Autoleucel (cilta-cel) […]
Shots: The approval is based on P-lll CASSIOPEIA (MMY3006) Study involve the assessing of Darzalex (daratumumab) + bortezomib, thalidomide, and dexamethasone (VTd) for the treatment […]
Shots: The approval is based on P-ll/lll study involve the assessment of Comirnaty (BNT162b2) vs PBO in 44,000 patients aged ≥16 yrs. in the ratio […]
Shots: The approval is based on data assessing bioequivalence and AEs associated with IM administration vs SC administration of Plegridy in healthy volunteers Result: The […]
Shots: The approval is based on the P-III ADAURA trial assessing Tagrisso (80mg, qd) vs PBO in 682 patients with stage IB, II, IIIA EGFRm […]
Shots: The US FDA has authorized EUA of mRNA-1273 vaccine against COVID-19 in individuals ≥18yrs. The delivery to the US govt. will begin imminently while […]
Shots: The approval is based on P-III ATLAS, FLAIR and ATLAS-2M studies assessing Vocabria (cabotegravir) + Janssen’s Rekambys (rilpivirine inj.) or Edurant (rilpivirine tablets) in […]
Shots: The approval follows BTD and PR & is based on P-lll BLISS-LN study involves assessing Benlysta (IV, 10 mg/kg) + SOC vs PBO + […]
Shots: The VRBPAC voted 20-0, with one abstention that the benefits of the Moderna’s vaccine outweighed its risks for use in people aged ≥18yrs The […]
Shots: The approval is based on P-II ZUMA-2 study assessing Tecartus in 74 patients with r/r MCL prior treated with anthracycline/ bendamustine-containing CT, an anti-CD20 […]
Shots: The NDA submission is based P-II CodeBreaK 100 study assessing Sotorasib in patients with KRAS G12C-mutated NSCLC prior treated with CT and immunotherapy The […]
Shots The Health Canada has approved Zolgensma (onasemnogene abeparvovec) for pediatric patients with 5q SMA with bi-allelic mutations in the SMN1 gene and 3 or […]
Shots: The US FDA’s CRDAC voted 12 to 1 supporting the use of Entresto (sacubitril/valsartan) in the treatment of patients with HFpEF The decision was […]
Shots: The US FDA has granted EUA for Ellume COVID-19 home test for non-prescription home use in symptomatic and asymptomatic individuals aged ≥2yrs. The data […]
Shots: OsteoBoost receives the US FDA’s BDD to reduce the risk of osteoporosis. It uses vibration technology that delivers mechanical stimulation to the hips & […]
Shots: The US FDA has accepted the NDA and granted PR for TAK-721 for the treatment of EoE. If approved, TAK-721 will be the first […]
Shots: The approval is based on P-III studies KX01-AK-003 and KX01-AK-004 that evaluated the efficacy and safety of Klisyri (tirbanibulin, ointment 1%, 10 mg/g) vs […]
Shots: AstraZeneca’s Imfinzi durvalumab (1500mg, fd, q4w) is recommended for approval in the EU for an additional dosing option in the approved indication of LA, […]
Shots: The approval is based on ENSEMBLE PLUS study, which demonstrated similar frequency and severity of IRRs for 2hrs. Ocrevus infusion time vs conventional 3.5hrs […]
Shots: The recommendation is based on a P-II DESTINY-Breast01 study assessing trastuzumab deruxtecan in patients with HER2 positive unresectable/ m-BC prior treated with trastuzumab emtansine […]
Shots: The approval is based on P-lll ETHOS involve the assessing of Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) vs Bevespi Aerosphere and PT009 in adult patients […]
Shots: Pfizer & BioNTech received the US FDA’s EUA for BNT162b2 for patients aged ≥16yrs with COVID-19. The companies are gathering additional data & prepared […]
Shots: The submission is based on P-lll EMERGE and ENGAGE study assessing aducanumab vs PBO in patients with AD. The studies evaluate the efficacy of […]
Shots: Health Canada has granted authorization under interim order for the emergency use of BNT162b2. The distribution of the vaccine in Canada will be prioritized […]
Shots: The BT designation is based on P-II CodeBreaK 100 study assessing Sotorasib in patients with advanced NSCLC with KRAS G12C mutation whose cancer had […]
Shots: Abbott’s next-generation, sensor-based glucose monitoring technology, FreeStyle Libre 2, received Health Canada’s approval for adults & children with diabetes The system continuously measures glucose […]
Shots: Pfizer & BioNTech reports that the MHRA in the UK has granted a temporary authorization for the EU for BNT162b2 against COVID-19. The distribution […]
Shots: The approval is based on P-I/II ARROW study involve assessing Gavreto (400mg, qd) n people with rearranged during transfection (RET) fusion-positive NSCLC, RET-mutant MTC, […]
Shots: The companies have submitted CMA to the EMA for BNT162b2, against COVID-19. The submission completes the rolling review process initiated on Oct 6, 2020 […]
Shots: The approval is based on P-III POLYP 1 & 2 trials assessing Xolair vs PBO in 138 & 127 adult patients with nasal polyps […]
Shots: The EC’s approval is based on a P-III study assessing Dupixent (300mg, q4w & 200mg, q2w) + TCS vas TCS alone in children aged […]
Shots: The P-III COVE study demonstrated 94.1% efficacy against COVID-19 and 100% efficacy against severe COVID-19. The vaccine was well tolerated with no serious safety […]
Shots: The approval is based on a DAPA-HF trial assessing Forxiga (10mg, qd) + SOC vs PBO + SOC in 4,744 patients with HFrEF (LVEF […]
Shots: The approval of additional indication is based on a P-lll study involve the assessing the efficacy and safety of Humira targeting the patients with […]
Shots: The approval is based on P-III BLOCKSTONE study assessing Xofluza (baloxavir marboxil, 10/20mg) vs PBO in patients in household members aged ≥12yrs. who was […]
Shots: Egle has achieved the first milestone in its research agreement with Takeda, signed in June’2020. Egle will validate novel tumor-infiltrating regulatory T-cell targets while […]
Shots: The MAA is based on a P-II VISION study assessing Tepotinib as monothx. in patients with advanced NSCLC of METex14 skipping alterations, prospectively assessed […]
Shots: The US FDA has approved Danyelza (40mg/10ml) and is indicated in combination with GM-CSF for pediatric patients aged 1yrs. & older and adult patients […]
Shots: The approval is based on P-lll DISCOVER-1 & -2 study assessing Tremfya (100mg q4w and q8w) vs PBO in 381 & 739 patients with […]
Shots: The approval is based on P-III ILLUMINATE-A & -B trials. The studies demonstrating reductions in urinary oxalate and encourage safety and tolerability in pediatric […]
Shots: The approval is based on P-lll ATTRACTION-3 study involve the assessment of Opdivo vs CT (docetaxel or paclitaxel) for patients with esophageal cancer refractory/ […]
Shots: The approval is based on P-III BLOCKSTONE study assessing a single dose of Xofluza vs PBO in household members who were living with someone […]
Shots: The Progeria Research Foundation and Eiger reported the US FDA’s approval of Zokinvy (lonafarnib) for the treatment of HGPS or progeria and processing-deficient progeroid […]
Shots: The authorization is based on P-II BLAZE-1 study assessing the efficacy and safety of bamlanivimab (700/2800/7000 mg) alone or in combination with a second […]
Shots: The FDA has approved Imfinzi for an additional dosing option (1500mg, FD, q4w) in the approved indications of unresectable stage III NSCLC after CRT […]
Shots: In terms of the agreement, lilly will commercialize the system, which is currently in development & will include an insulin pump developed & manufactured […]
Shots: The EUA is based on ACCT-2 study assessing baricitinib (4mg, qd for 14 days or until hospital discharge) in combination with remdesivir vs PBO […]
Shots: In the three large-scale global clinical trials assessing Bronchitol in 761 patients, sustained improvement in FEV1 (Forced Expiratory Volume) with Bronchitol use vs. control […]
Shots: The approval is based on two P-III studies assessing the safety and efficacy of Supemtek (quadrivalent recombinant influenza vaccine) in 10,000 patients with influenza […]
Shots: EMA accepted the review of MAA for SB11 in Oct 2020. If approved, SB11 will add to the biosimilars portfolio developed by Samsung Bioepis […]
Shots: Deep Genomics will receive an undisclosed upfront payment and is eligible to receive development milestones, BioMarin will receive an exclusive option to obtain Deep […]
Shots: The US FDA accepted for priority review the BLA of avalglucosidase alfa for long-term enzyme replacement therapy for the treatment of patients with Pompe […]
Shots: This BT designation is based on P-IIb/III HPTN 083 study assessing cabotegravir (q8w) vs. FTC/TDF tablets (qd PO, 200/300 mg) in a study population […]
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