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RSS FeedPosted by Michael Wonder on 07 Mar 2026
FDA official offers insights on agency’s criteria for real world data in regulatory submissions
6 March 2026 - The US FDA will consider several factors when determining whether to accept real world data and ...
Posted by Michael Wonder on 07 Mar 2026
US FDA approves Bristol Myers Squibb’s Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis
6 March 2026 - Significantly more patients treated with once daily, oral Sotyktu achieved an ACR20 response compared with placebo at ...
Posted by Michael Wonder on 07 Mar 2026
Lantheus announces FDA approval of Pylarify TruVu (piflufolastat F 18) injection
6 March 2026 - Pylarify TruVu is expected to launch in Q4, 2026, with a phased geographic rollout to support a ...
Posted by Michael Wonder on 05 Mar 2026
FDA approves teclistamab in combination with daratumumab hyaluronidase-fihj for relapsed or refractory multiple myeloma
5 March 2026 - Today, the FDA approved teclistamab (Tecvayli, Janssen Biotech) in combination with daratumumab hyaluronidase-fihj for adult patients ...
Posted by Michael Wonder on 05 Mar 2026
Hemab Therapeutics receives FDA breakthrough therapy designation for sutacimig in Glanzmann thrombasthenia
5 March 2026 - Sutacimig has potential to become a first in class prophylactic treatment for Glanzmann thrombasthenia, an inherited serious ...
Posted by Michael Wonder on 05 Mar 2026
PDUFA action date for Hansa Biopharma's imlifidase BLA set for 19 December 2026
4 March 2026 - If approved, imlifidase will be the first treatment to address highly sensitised patients awaiting kidney transplantation. ...
Posted by Michael Wonder on 05 Mar 2026
Priovant announces FDA acceptance and priority review of new drug application for brepocitinib in dermatomyositis
3 March 2026 - Priovant Therapeutics today announced that the US FDA has accepted its new drug application for brepocitinib for ...
Posted by Michael Wonder on 04 Mar 2026
Affinia Therapeutics granted FDA fast track designation for AFTX-201 as a treatment for people living with BAG3-associated dilated cardiomyopathy
4 March 2026 - Affinia Therapeutics today announced that the US FDA has granted fast track designation for AFTX-201, a potential ...
Posted by Michael Wonder on 04 Mar 2026
FDA approves first generic of Flovent HFA for treatment of asthma
3 March 2026 - Today, the US FDA approved the first generic of Flovent HFA (fluticasone propionate) inhalation aerosol, 44 mcg/actuation, ...
Posted by Michael Wonder on 03 Mar 2026
Johnson & Johnson therapy nipocalimab granted US FDA fast track designation in systemic lupus erythematosus
3 March 2026 - Johnson & Johnson today announced that nipocalimaba was granted US FDA fast track designation as a potential ...
Posted by Michael Wonder on 02 Mar 2026
Takeda and Protagonist announce US FDA accepts new drug application and grants priority review for rusfertide as a potential first in class therapy for polycythemia vera
2 March 2026 - Takeda and Protagonist Therapeutics today announced that the US FDA accepted the new drug application and granted ...
Posted by Michael Wonder on 02 Mar 2026
FDA accepts Viatris supplemental new drug application for MR-141 (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia
25 February 2026 - Viatris today announced that the US FDA has accepted for review the supplemental new drug application ...
Posted by Michael Wonder on 01 Mar 2026
Eton Pharmaceuticals announces US FDA approval for Desmoda (desmopressin acetate) oral solution
25 February 2026 - Commercial launch expected on 9 March 2026. ...
Posted by Michael Wonder on 01 Mar 2026
US FDA approves BioMarin’s Palynziq (pegvaliase-pqpz) for adolescents 12 years of age and older with phenylketonuria
27 February 2026 - BioMarin today announced that the US FDA has approved the company's supplemental biologics license application for Palynziq ...
Posted by Michael Wonder on 28 Feb 2026
FDA approves Novo Nordisk's Sogroya as the first and only once weekly, long-acting growth hormone for three additional paediatric indications
27 February 2026 - Novo Nordisk today announced that the US FDA has approved three new indications for once weekly Sogroya ...