Medical Writing — An Outsourcing Competency
The history of medical writing began with the rise of the modern clinical trial. A medical writer can be your most pivotal ally in a […]
The history of medical writing began with the rise of the modern clinical trial. A medical writer can be your most pivotal ally in a […]
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 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 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 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 US FDA has accepted the BLA under the 351(k) for CHS-1420 with an anticipated BsUFA date as Dec’2021 The company plans to launch […]
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 FDA has issued a EUA for Simoa Semi-Quantitative SARS-CoV-2 IgG Ab test and can be operated on Simoa HD-X Analyzer The test checks […]
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 sNDA submission is based on P-II/P-III Clinical trial assessing Dextenza(dexamethasone ophthalmic insert, 0.4mg) vs PBO for the treatment of Ocular Itching associated with […]
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 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 trial assessing Riabni (375 mg/m2, IV) vs Rituxan once weekly for 4wks. followed by dosing @12wks. & 20wks. in […]
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 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 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: 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: 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 approval is based on P-III POLYP 1 & 2 trials assessing Xolair vs PBO in 138 & 127 adult patients with nasal polyps […]
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 US FDA has granted 510(k) clearance for CorticoMetrics’ AI-based software, THINQ, for MRI brain volumetric reporting. The software can provide radiologists & neurologists […]
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-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 US FDA has accepted the BLA of AVT02 for review and is expected to decide on the filing in Sept’2021 while the EMA […]
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 Lucira’s COVID-19 all-in-one test kit test has been authorized for home use with self-collected nasal swab samples in individuals aged≥ 14yrs. who are […]
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 […]
Shots: The US FDA has permitted marketing of a device intended for the temporary reduction of sleep disturbance related to nightmares in patients aged ≥22 […]
Shots: The MAA submitted to the EMA and the NDA to the US is based on P-III FIDELIO-DKD study assessing finerenone (10/20mg, qd) + SOC […]
Shots: The EUA is based on P-II BLAZE-1 study assessing bamlanivimab (700/2800/7000 mg) as monothx. vs PBO or in combination with second Ab for the […]
Shots: The advisory committee voted 1-8, with 2 members voting uncertain that EMERGE study (without regard for ENGAGE study) provides strong evidence, supporting the effectiveness […]
Shots: The approval is based on P-III THALES study involves assessing Brilinta (180mg as a loading dose followed by 90mg, bid) + aspirin vs aspirin […]
Shots: The approval is based on the RANGER II SFA pivotal study assessing the Ranger DCB vs standard PTA for the treatment in patients with […]
Shots: The sNDA submission is based on P-lll Route-6 study assessing PP6M vs PP3M in 702 patients with schizophrenia previously stabilized on corresponding doses of […]
The third quarter of 2020 was flooded with major acquisitions in the pharma and biotech industry along with multiple approvals. Starting with the latest acquisitions, […]
Shots: The approval is based on ABRE clinical study assessing the Abre stent in 200 patients with iliofemoral venous outflow obstruction across the spectrum of […]
Shots: The company reports NDA submission and request for PR to the US FDA for hyperpolarised 129Xenon gas used to evaluate the pulmonary function and […]
Shots: The BLA submission is based on L-MIND P-II trial data results assessing Tafasitamab + lenalidomide in patients with r/r DLBCL and retrospective observational matched […]
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