Novartis’ Pluvicto gets first European approval in GB
Novartis has secured its first approval in Europe for prostate cancer radioligand therapy Pluvicto, getting a green light from the UK Medicines and Healthcare products […]
Novartis has secured its first approval in Europe for prostate cancer radioligand therapy Pluvicto, getting a green light from the UK Medicines and Healthcare products […]
Bayer has won a key FDA approval to extend the use of its prostate cancer therapy Nubeqa, as it tries to claim market share from […]
The FDA has approved AstraZeneca and Daiichi Sankyo’s Enhertu as the first targeted therapy for HER2-low breast cancer, a new category of the disease that […]
Incyte’s Opzelura cream has become the first medical treatment approved to re-pigment the skin of people with vitiligo in the US, adding to its current […]
China’s Simcere Pharmaceutical has been granted approval in its home market for Cosela, a drug designed to limit the side effects of cancer chemotherapy partnered […]
AstraZeneca and Daiichi Sankyo have claimed approval in the EU for Enhertu as a second-line therapy for HER2-positive metastatic breast cancer, moving the drug up […]
Pfizer is still waiting for the green light to complete an acquisition of digital health company ResApp, a deal that looks even better now that […]
On the heels of approvals in the US, Europe and Japan, Bayer’s Kerendia for chronic kidney disease (CKD) associated with type 2 diabetes has been […]
Sanofi has claimed approval in the EU for Xenpozyme as a treatment for acid sphingomyelinase deficiency (ASMD) – which becomes the first and only treatment […]
The EMA’s human medicines advisory committee has recommended that BioMarin Pharmaceutical’s haemophilia A gene therapy Roctavian be approved in the EU, removing one of the […]
AbbVie’s IL-23 inhibitor Skyrizi trailed some of its rivals in its first indication psoriasis, but has leapfrogged into first place in Crohn’s disease after getting […]
Four years after getting the first drug approved by the FDA to treat rare disease hereditary ATTR amyloidosis, Alnylam has got the go-ahead for a […]
Amylyx Pharmaceuticals’ efforts to bring its amyotrophic lateral sclerosis therapy AMX0035 to market in the US have run into some roadblocks, so an approval by […]
While Merck & Co’s Keytruda is the undisputed leader of the non-small cell lung cancer (NSCLC) category, there’s one category where it lags behind Roche’s […]
Roche has secured its first regulatory approval for mosunetuzumab, a first-in-class CD20xCD3 bispecific antibody, as a treatment for patients with follicular lymphoma (FL) in the […]
Roche and PTC Therapeutics’ Evrysdi for spinal muscular atrophy (SMA) has been approved by the FDA for younger children with the rare disease, extending its […]
The FDA has cleared two combination drug regimens based on Bristol-Myers Squibb’s PD-1 inhibitor Opdivo for previously-untreated advanced oesophageal cancer, encroaching on territory held by […]
Johnson & Johnson and Legend Biotech will arrive at next week’s ASCO congress with a new EU approval for multiple myeloma CAR-T Carvykti. The European […]
After more than six years of development, Angle has scored an FDA approval for Parsortix as a diagnostic for metastatic breast cancer – the first […]
Roivant group company Dermavant has made the transition to a commercial-stage company after getting FDA approval for Vtama, a drug for psoriasis that it claims […]
Sanofi and Regeneron have added another string to the bow of their immunology blockbuster Dupixent with an FDA approval in eosinophilic oesophagitis (EoE), which could […]
Three years after it was formed as a spinout of Japanese drugmaker Takeda, Phathom Pharmaceuticals has racked up its first FDA approvals, and claimed a […]
The US FDA has authorised a new test that can detect amyloid plaques in early-stage Alzheimer’s disease without the use of PET scans, which expose […]
Novartis’ CAR-T Kymriah has become the first therapy in the category to be approved for the treatment of relapsed/refractory follicular lymphoma, ahead of Gilead Sciences’ […]
Idorsia has become the first drugmaker in the EU to claim approval for a drug for chronic insomnia in the dual orexin receptor antagonist class, […]
Bristol-Myers Squibb’s has become the first company to bring a cardiac myosin inhibitor through to FDA approval, claiming a green light from the US regulator […]
Vifor Pharma and Cara Therapeutics’ Kapruvia has become the first drug to be approved in the EU to treat one of the most common and […]
BioXcel Therapeutics has claimed its first product approval, getting a green light from the FDA for Igalmi as a treatment for agitation in people with […]
The EU regulator has started a review of Novartis’ PD-1 inhibitor tislelizumab – licensed from Chinese biotech BeiGene – for oesophageal and lung cancers, ahead of […]
Immunocore now has approval on both side of the Atlantic for Kimmtrak – the first cancer therapeutic based on T cell receptor (TCR) technology – […]
Gilead Sciences’ Kite Pharma has become the first drugmaker to get FDA approval to use a CAR-T therapy after just one earlier systemic therapy, moving […]
Novartis has been steadily investing in radiopharmaceuticals over the last few years, and one of those deals has just paid off with an FDA approval […]
People with CDKL5 deficiency disorder (CDD) now have their first FDA-approved treatment, after the US regulator gave the nod to Marinus Pharma’s Ztalmy for the […]
Bristol-Myers Squibb has won FDA approval for the first LAG-3 inhibitor drug ahead of its rivals in cancer immunotherapy including Merck & Co. The US […]
Viatris (formerly Mylan) has become the first drugmaker to win full FDA approval for a generic version of AstraZeneca’s top-selling respiratory drug Symbicort, although launch […]
The FDA has cleared AstraZeneca and Merck & Co’s Lynparza as an adjuvant or neoadjuvant treatment for breast cancer, extending its lead over pretenders to […]
The UK’s National Institute for Health and Care Excellence (NICE) has recommended GlaxoSmithKline’s (GSK) ZEJULA (niraparib) for some forms of ovarian, fallopian tube, and peritoneal […]
The UK’s National Institute for Health and Care Excellence (NICE) has recommended GlaxoSmithKline’s (GSK) ZEJULA (niraparib) for some forms of ovarian, fallopian tube, and peritoneal […]
The FDA has approved expanded labelling for Abbott’s CardioMEMS HF System, an implantable sensor that provides an early warning of worsening heart failure, that could […]
Bayer has claimed EU approval for Kerendia, its new drug for chronic kidney disease (CKD) in people with type 2 diabetes, as the company tries […]
Global Blood Therapeutics’ run of positive regulatory news for its oral sickle cell disease treatment Oxbryta has continued with an approval for the drug in […]
lupusAstraZeneca’s Saphnelo has become the first new drug to be approved to treat the autoimmune disease systemic lupus erythematosus (SLE) in the EU for more […]
Sanofi has won FDA approval for its sutimlimab for cold agglutinin disease (CAD) at the second time of asking, becoming the first approved therapy for […]
The FDA has approved Roche’s much-anticipated faricimab for two major causes of blindness, setting up a market clash with Bayer and Regeneron’s market leading drug […]
Merck & Co has passed another milestone in its drive to move PD-1 inhibitor Keytruda earlier in the treatment pathway for cancer, with the European […]
Immunocore has secured a piece of biotech industry history, becoming the first company to get an FDA approval for a cancer therapeutic based on T […]
Swiss biotech Idorsia has claimed FDA approval for its first product – insomnia treatment Quviviq – setting up a market challenge to class rivals from […]
Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. […]
At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. […]
The FDA has approved AstraZeneca and Amgen’s severe asthma hope tezepelumab, exonerating the drugmakers’ decision to press ahead with a regulatory filing despite a failed […]
Bristol-Myers Squibb’s rheumatoid arthritis drug Orencia has been approved by the FDA to prevent graft versus host disease (GvHD), a serious complication of haematopoietic stem […]
Apellis Pharma and partner Sobi have won EU approval for their paroxysmal nocturnal haemoglobinuria (PNH) drug pegcetacoplan in Europe, with a more restricted label than […]
The European Commission has moved swiftly to grant full approval to Roche’s Actemra/RoActemra as a treatment for severe COVID-19, clearing the drug within 24 hours […]
Merck & Co’s strategy of pushing Keytruda earlier in the treatment pathway for cancers has secured anther victory, after the FDA approved the immunotherapy for […]
The UK medicines regulator has approved GlaxoSmithKline and Vir Biotech’s antibody for COVID-19, Xevudy, which has been shown to be effective against the new Omicron […]
Roche and Blueprint Medicines have opened a second front in their rivalry with Eli Lilly in RET-mutated cancers, after getting approval for Gavreto from the […]
Merck & Co has chalked up another win in drive to move PD-1 inhibitor Keytruda earlier in the treatment pathway for cancer, after the FDA […]
Novartis has claimed FDA approval for one of its ‘wild card’ drugs – Scemblix – a first-in-class STAMP inhibitor for patients with previously-treated chronic myeloid […]
Daiichi Sankyo has launched its oncolytic virus therapy Delytact in Japan – its first world market – as a treatment for malignant glioma, an aggressive […]
The FDA has approved the first and so far only pharmacological treatment for presbyopia, a sight condition that typically starts in middle age and involves […]
Merck & Co has claimed EU approval for Keytruda in triple-negative breast cancer (TNBC), a particularly hard-to-treat form of the disease. The European Commission has […]
Biosimilar competition to AbbVie’s big-selling Humira drug in the US has just been ratcheted up by the FDA approval of Boehringer Ingelheim’s Cyltezo – which […]
Roche has claimed an earlier-than-expected FDA approval for its checkpoint inhibitor Tecentriq in non-small cell lung cancer (NSCLC), giving the drug a lead in early-stage […]
ChemoCentryx has claimed FDA approval for its avacopan drug for a rare autoimmune disease, becoming the first orally-active drug that targets the complement C5 receptor. […]
The FDA has approved Kite Pharma’s Tecartus as a treatment for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL), making CAR-T therapy […]
Takeda has chalked up another milestone for its Alofisel cell therapy for a complication of Crohn’s disease, becoming the first allogeneic stem cell therapy to […]
The FDA has approved Incyte’s Opzelura cream for atopic dermatitis, commonly called eczema, becoming the first and only topical JAK inhibitor registered in the US. […]
Antibody-drug conjugate (ADC) specialist Seagen has claimed its fourth product approval in the US, getting the nod from the FDA for Tivdak as a second-line […]
Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, […]
Takeda has had a run of bad luck with its Wave1 pipeline of new drug candidates of late, but can now celebrate a vestry after […]
Pfizer has claimed its first regulatory approval worldwide for Cibinqo, its JAK inhibitor for atopic dermatitis, from the UK’s Medicines and Healthcare products Regulatory Agency […]
One of the biggest challenges to treating schizophrenia is non-compliance with treatment, but Johnson & Johnson’s pharma unit Janssen is trumpeting a new version of […]
Incyte and MorphoSys’ antibody therapy tafasitamab has been approved in Europe, promising to provide a more convenient alternative to expensive and cumbersome CAR-T therapies for […]
The FDA may be reluctant to trust JAK inhibitors, but the European Commission is more willing, and has just handed a first-in-class approval in atopic […]
One of the most common and challenging side effects for people undergoing dialysis for chronic kidney disease – chronic itching – now has an FDA-approved […]
UCB has been bringing up the rear in the IL-17 inhibitor category with bimekizumab, but now has EU approval for the drug and thinks it […]
Pfizer and BioNTech’s COVID-19 vaccine was the first to get emergency use authorisation (EUA) from the FDA, and has also become the first to get […]
The COVID-19 pandemic accelerated the development of mRNA-based vaccines, and its influence has now extended to DNA-based shots as well, with Zydus Cadila’s ZyCoV-D getting […]
Bristol-Myers Squibb has scored a win in its drive to get Opdivo into earlier lines of cancer therapy, getting FDA approval for the drug for […]
The EU regulator has approved FibroGen and Astellas Evrenzo for adults with anaemia caused by chronic kidney disease (CKD), just days after the FDA turned […]
Eli Lilly and Boehringer Ingelheim have claimed FDA approval for their diabetes therapy Jardiance in heart failure with reduced ejection fraction (HFreF), setting up a […]
The FDA has approved GlaxoSmithKline’s latecomer PD-1 inhibitor Jemperli for a second use that will significantly extend the patient population eligible for treatment with the […]
Merck & Co has extended its range of cancer medicines in the US after claiming FDA approval for Welireg – a drug it acquired as […]
Sanofi has added another string to its Pompe disease therapy bow, after getting FDA approval for Nexviazyme, its latest therapy for the rare, inherited disorder. […]
AstraZeneca has completed the resurrection of its anifrolumab drug for systemic lupus erythematosus (SLE) after claiming FDA approval for the drug as an add-on therapy […]
Merck & Co’s Keytruda has just picked up its 30th approval from the FDA, and it is a good one – early-stage triple-negative breast cancer […]
Bluebird bio has its first approval for Skysona (formerly Lenti-D), its gene therapy for children with the rare disease cerebral adrenoleukodystrophy (CALD), after getting the […]
Bayer’s big investment in time and money on the development of finerenone for chronic kidney disease (CKD) in diabetics has paid off with an FDA […]
Merck & Co will voluntarily withdraw a US marketing approval for cancer immunotherapy blockbuster Keytruda in gastric cancer, after studies intended to confirm its efficacy […]
FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market. […]
The UK drugs regulator has approved Seagen’s Tukysa as a third-line treatment for HER2-positive breast cancer, shortly after it was given a green light by […]
Sweden’s Sobi has secured EU approval for Doptelet in primary chronic immune thrombocytopenia (ITP), an indication that the company expects to accelerate sales of the […]
Roche has secured EU approval for Phesgo, a fixed-dose combination of its breast cancer drugs Herceptin and Perjeta that is easier and cheaper to administer […]
A new EMA approval has expanded the use of Vertex Pharma’s exon-skipping cystic fibrosis therapy Symkevi to children as young as six if they have […]
GlaxoSmithKline has approval on both sides of the Atlantic for its multiple myeloma drug Blenrep, after getting the nod from the European Commission. Blenrep (belantamab […]
Copyright © 2024 | WordPress Theme by MH Themes