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RSS FeedPosted by Michael Wonder on 28 Jan 2026
Otsuka announces FDA acceptance and priority review of new drug application for centanafadine for the treatment of ADHD in children, adolescents, and adults
27 January 2026 - The PDUFA target action date is 24 July 2026. ...
Posted by Michael Wonder on 28 Jan 2026
Novel drug approvals for 2025
23 January 2026 - In 2025, the CDER approved 46 new drugs never before approved or marketed in the US, known ...
Posted by Michael Wonder on 27 Jan 2026
FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma
27 January 2026 - Today, the FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech) in combination with bortezomib, lenalidomide, ...
Posted by Michael Wonder on 27 Jan 2026
FDA accepts Leqembi Iqlik (lecanemab-irmb) supplemental biologics license application as a subcutaneous starting dose for the treatment of early Alzheimer’s disease under priority peview
26 January 2026 - Eisai and Biogen announced today that the US FDA has accepted for review Eisai’s supplemental biologics license ...
Posted by Michael Wonder on 27 Jan 2026
MannKind announces FDA approval of updated Afrezza label providing starting dose guidance when switching from multiple daily injections or insulin pump mealtime therapy
26 January 2026 - Updated initial conversion table based on clinical trials in adults showing significantly improved mealtime glycemic excursions. ...
Posted by Michael Wonder on 23 Jan 2026
Guardant Health receives FDA approval for Guardant360 CDx as companion diagnostic for Braftovi (encorafenib) combination in patients with BRAF V600E mutant metastatic colorectal cancer
22 January 2026 - Approval supported by data from Pfizer’s BREAKWATER trial demonstrating improved outcomes in BRAF V600E-mutant metastatic colorectal cancer ...
Posted by Michael Wonder on 21 Jan 2026
BioXcel Therapeutics submits supplemental new drug application to US FDA for Igalmi label expansion in the at home setting
20 January 2026 - BioXcel Therapeutics today announced it submitted a supplemental new drug application to the US FDA for the ...
Posted by Michael Wonder on 20 Jan 2026
Celcuity announces FDA acceptance of new drug application for gedatolisib in HR+/HER2-/PIK3CA wild type advanced breast cancer
20 January 2026 - Celcuity today announced that the US FDA has accepted for filing its new drug application for gedatolisib ...
Posted by Michael Wonder on 19 Jan 2026
Organon announces US FDA approval of supplemental new drug application extending duration of use of Nexplanon (etonogestrel implant) 68 mg radiopaque
16 January 2026 - Organon announced today that the US FDA has approved a supplemental new drug application for Nexplanon (etonogestrel ...
Posted by Michael Wonder on 17 Jan 2026
Some drugmakers quietly concerned about legal risk with speedy FDA review program
16 January 2026 - More than half a dozen major drug makers are participating in the Trump Administration's speedier review ...
Posted by Michael Wonder on 17 Jan 2026
US FDA delays two drug reviews in new voucher program after safety, efficacy concerns
15 January 2026 - The US FDA has delayed reviews of two drugs chosen for the Trump Administration's new fast ...
Posted by Michael Wonder on 16 Jan 2026
FDA reports lack of interest, high rejection rate for its STAR program
15 January 2026 - The US FDA said there is "minimal industry interest" from companies to participate in its Split ...
Posted by Michael Wonder on 14 Jan 2026
Travere Therapeutics announces FDA extends review of sNDA for Filspari (sparsentan) in FSGS
13 January 2026 - Travere Therapeutics announced that today the US FDA has extended the review timeline of its supplemental new ...
Posted by Michael Wonder on 14 Jan 2026
Henlius' fifth US filing product bevacizumab biosimilar HLX04 receives FDA BLA acceptance
13 January 2026 - Shanghai Henlius Biotech announced that the biologics license application for HLX04, the Company’s independently developed bevacizumab biosimilar ...
Posted by Michael Wonder on 14 Jan 2026
argenx announces FDA acceptance of supplemental biologics license application with priority review for Vyvgart in AChR-Ab seronegative gMG
13 January 2026 - argenx today announced that the US FDA has accepted for priority review a supplemental biologics license application ...