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RSS FeedPosted by Michael Wonder on 31 May 2026
MannKind announces FDA approval of Afrezza, the first and only inhaled mealtime insulin for use in children and adolescents aged 6 and older living with diabetes
29 May 2026 - Eligible patients can access Afrezza today for $35 or less per month, with dedicated support through MannKind ...
Posted by Michael Wonder on 31 May 2026
FDA grants breakthrough therapy designation for calderasib (MK-1084), an investigational KRAS G12C inhibitor, for certain patients with newly diagnosed metastatic KRAS G12C mutant non-small cell lung cancer
29 May 2026 - First breakthrough therapy designation for calderasib, supported by positive data from the Phase 1 KANDLELIT-001 trial. ...
Posted by Michael Wonder on 29 May 2026
Zydus Therapeutics new drug application for saroglitazar to treat primary biliary cholangitis granted priority review by the US FDA
28 May 2026 - Zydus Therapeutics today announced that the US FDA granted priority review to the new drug application ...
Posted by Michael Wonder on 29 May 2026
Sanofi’s venglustat accepted for priority review in the US to treat type 3 Gaucher disease
28 May 2026 - The US FDA has granted priority review to the new drug application for venglustat, a novel, ...
Posted 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 28 May 2026
Solu Therapeutics granted FDA fast track designation for STX-0712 for treatment of chronic myelomonocytic leukaemia
27 May 2026 - Solu Therapeutics today announced that the US FDA has granted fast track designation to STX-0712, the company's ...
Posted by Michael Wonder on 27 May 2026
Outlook Therapeutics wins appeal following formal dispute resolution process for ONS-5010/Lytenava (bevacizumab-vikg) company plans to resubmit BLA to the FDA in June 2026
26 May 2026 - Outlook Therapeutics today announced that the US FDA has granted the appeal following completion of the ...
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 ...