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RSS FeedPosted 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 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 ...
Posted by Michael Wonder on 13 Jan 2026
Summit Therapeutics announces submission of biologics license application to US FDA seeking approval for ivonescimab in combination with chemotherapy in second-line (or later) treatment of patients with EGFRm NSCLC
12 January 2026 - Summit Therapeutics today announced that it has submitted a biologics license application to the US FDA seeking ...
Posted by Michael Wonder on 13 Jan 2026
Sebela Pharmaceuticals announces submission of new drug application to FDA for tegoprazan for the treatment of gastro-oesophageal reflux disease
12 January 2026 - Braintree Laboratories, a part of Sebela Pharmaceuticals, announced that it submitted a new drug application on 9 ...
Posted by Michael Wonder on 12 Jan 2026
Atara Biotherapeutics provides regulatory and business update on Ebvallo (tabelecleucel)
12 January 2026 - Atara Biotherapeutics today announced that the US FDA has issued a complete response letter for the ...
Posted by Michael Wonder on 11 Jan 2026
Aquestive Therapeutics announces regulatory development for Anaphylm (dibutepinephrine) sublingual film
9 January 2026 - Announces receipt of FDA letter stating it has identified deficiencies that preclude labeling discussions for Anaphylm at ...
Posted by Michael Wonder on 11 Jan 2026
Camurus announces FDA acceptance of NDA resubmission for Oclaiz for the treatment of acromegaly
9 January 2026 - Camurus today announced that the US FDA has accepted for review the company's resubmission of the new ...
Posted by Michael Wonder on 08 Jan 2026
Vanda Pharmaceuticals announces receipt of FDA decision letter on Hetlioz supplemental new drug application for jet lag disorder
8 January 2026 - Vanda Pharmaceuticals today announced that it has received a decision letter from the US FDA's Center for ...
Posted by Michael Wonder on 08 Jan 2026
Vera Therapeutics announces US FDA granted priority review to biologics license application for atacicept for treatment of adults with IgA nephropathy
7 January 2026 - Vera Therapeutics today announced the atacicept biologics license application for the treatment of adults with immunoglobulin A ...
Posted by Michael Wonder on 07 Jan 2026
Biosplice announces the submission of its new drug application to the FDA for lorecivivint to treat knee osteoarthritis
6 January 2026 - Biosplice Therapeutics announced today that it has submitted its new drug application to the FDA for approval ...
Posted by Michael Wonder on 06 Jan 2026
Moderna announces global regulatory submissions for its investigational seasonal influenza vaccine
5 January 2026 - Moderna today provided an update on regulatory submissions for its investigational seasonal influenza vaccine, mRNA-1010, for adults ...