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RSS FeedPosted by Michael Wonder on 09 Jun 2026
US FDA accepts Takeda's application for intravenous Entyvio (vedolizumab) in paediatric ulcerative colitis and Crohn's disease
9 June 2026 - Takeda today announced the US FDA has accepted for review its supplemental biologics license application for intravenous ...
Posted by Michael Wonder on 09 Jun 2026
Alvotech announces FDA acceptance of biologics license application for AVT16, a proposed interchangeable biosimilar to Entyvio
8 June 2026 - Alvotech today announced that the US FDA has accepted for review a biologics license application for ...
Posted by Michael Wonder on 07 Jun 2026
Boan Biotech submits a biologics license application for two denosumab biosimilars in the US
29 May 2026 - Boan Biotech announced today that it has submitted a biologics license application to the US FDA for ...
Posted by Michael Wonder on 04 Jun 2026
Pharming announces US FDA acceptance of sNDA resubmission for Joenja (leniolisib) to treat children aged 4 to 11 years with APDS
4 June 2026 - Pharming today announced that the US FDA has accepted its resubmitted supplemental new drug application seeking approval ...
Posted by Michael Wonder on 03 Jun 2026
Cingulate receives complete response letter from FDA for CTx-1301
2 June 2026 - Cingulate today announced that the US FDA has issued a complete response letter for its new ...
Posted by Michael Wonder on 02 Jun 2026
FDA accepts new drug application for Roche’s giredestrant in oestrogen receptor positive early-stage breast cancer, the first and only oral SERD with positive phase III results in the curative setting
2 June 2026 - Roche announced today that the US FDA has accepted the company’s new drug application under priority review ...
Posted by Michael Wonder on 02 Jun 2026
Vertex announces US FDA acceptance of biologics license application for accelerated approval of povetacicept in IgA nephropathy
1 June 2026 - 2026-- Vertex Pharmaceuticals today announced the US FDA has accepted its biologics license application submission for ...
Posted by Michael Wonder on 02 Jun 2026
Zenas BioPharma announces submission of biologics license application to US FDA for obexelimab in IgG4-RD
28 May 2026 - BLA submission based on positive results from Phase 3 INDIGO trial. ...
Posted by Michael Wonder on 02 Jun 2026
US FDA accepts for priority review Bristol Myers Squibb’s supplemental new drug application for Camzyos (mavacamten) to treat adolescents with symptomatic obstructive hypertrophic Cardiomyopathy
1 June 2026 - Bristol Myers Squibb today announced the US FDA accepted a supplemental new drug application for Camzyos ...
Posted by Michael Wonder on 02 Jun 2026
PolyPid completes new drug application submission to FDA for D-PLEX₁₀₀
1 June 2026 - PolyPid today announced the successful completion of its new drug application submission on a rolling review basis ...
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 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
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 ...