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RSS FeedPosted by Michael Wonder on 29 May 2026
FDA approves label expansion, cementing Tremfya as the only IL‑23 inhibitor proven to help stop further joint damage
28 May 2026 - Johnson & Johnson announced today that the US FDA has approved a supplemental biologics license application to ...
Posted by Michael Wonder on 29 May 2026
Imfinzi approved in the US in first and only immunotherapy combination for patients with BCG naïve, high risk non-muscle-invasive bladder cancer
28 May 2026 - Based on POTOMAC Phase 3 trial results which showed a 32% reduction in the risk of ...
Posted by Michael Wonder on 28 May 2026
Beren Therapeutics announces FDA extension of review period for new drug application for adrabetadex for the treatment of infantile-onset Niemann-Pick disease, type C
28 May 2026 - Beren Therapeutics announced that the US FDA has extended by three months the review timeline of its ...
Posted by Michael Wonder on 28 May 2026
Cogent Biosciences announces FDA acceptance of new drug application with priority review for bezuclastinib in combination with sunitinib for patients with GIST
28 May 2026 - New drug acceptance acceptance with priority review builds upon previous assignment of breakthrough therapy designation and real-time ...
Posted by Michael Wonder on 28 May 2026
FDA approves durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer
28 May 2026 - Today, the FDA approved durvalumab (Imfinzi, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for the treatment ...
Posted by Michael Wonder on 28 May 2026
US FDA approves Decnupaz (pivekimab sunirine-pvzy) for treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm, an ultra rare and aggressive blood cancer with limited treatment options
27 May 2026 - AbbVie today announced that the US FDA has approved Decnupaz (pivekimab sunirine-pvzy) for the treatment of ...
Posted by Michael Wonder on 28 May 2026
BridgeBio announces FDA acceptance and priority review of NDA for BBP-418 for LGMD2I/R9
27 May 2026 - BridgeBio Pharma today announced the FDA has accepted for filing its new drug application with priority review ...
Posted by Michael Wonder on 27 May 2026
FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic malignancy
27 May 2026 - Today, the FDA approved pivekimab sunirine-pvzy (Decnupaz, AbbVie), a CD123-directed antibody and alkylating agent conjugate, for ...
Posted by Michael Wonder on 27 May 2026
US FDA decision date extended for SERENA-6 filing of camizestrant to enable review of additional data
27 May 2026 - The US FDA has informed AstraZeneca that it will extend the PDUFA date to review additional data ...
Posted by Michael Wonder on 27 May 2026
Dyne Therapeutics announces submission of biologics license application to US FDA for z-rostudirsen in exon 51 Duchenne muscular dystrophy
26 May 2026 - Submission for accelerated approval based on dystrophin as a surrogate outcome. ...
Posted by Michael Wonder on 27 May 2026
Apotex expands ophthalmic portfolio with Health Canada approval of Iheezo
26 May 2026 - Apotex today announced that Health Canada has approved Iheezo (chloroprocaine hydrochloride ophthalmic gel 3%), a topical ...
Posted by Michael Wonder on 26 May 2026
Avanzanite Bioscience’s partner Agios announces Pyrukynd (mitapivat) approval in the European Union for adults with thalassaemia
22 May 2026 - Avanzanite Bioscience today reported that its partner, Agios Pharmaceuticals announced that the European Commission has granted marketing ...
Posted by Michael Wonder on 25 May 2026
First oral GLP-1 treatment for weight management
22 May 2026 - EMA has recommended an extension to the marketing authorisation for Wegovy (semaglutide) in the EU to add ...
Posted by Michael Wonder on 24 May 2026
FDA grants accelerated approval to Gilead’s Hepcludex (bulevirtide-gmod), the first and only approved treatment for chronic hepatitis delta virus
22 May 2026 - Approval introduces the first FDA approved therapy for this disease with limited treatment options and high ...
Posted by Michael Wonder on 22 May 2026
Otarmeni (lunsotogene parvec) receives EMA filing acceptance for genetic hearing loss
22 May 2026 - Regeneron Pharmaceuticals today announced the EMA has accepted for review under accelerated assessment the marketing authorisation application ...