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RSS FeedPosted by Michael Wonder on 24 Feb 2026
Armata Pharmaceuticals receives FDA Qualified Infectious Disease Product designation for AP-SA02
23 February 2026 - Armata Pharmaceuticals today announced that the US FDA has granted AP-SA02, the Company's Staphylococcus aureus ("S. aureus") ...
Posted by Michael Wonder on 23 Feb 2026
US FDA grants Reunion Neuroscience’s luvesilocin (RE104) breakthrough therapy designation status
23 February 2026 - Reunion Neuroscience today announced that the US FDA has granted breakthrough therapy designation to luvesilocin (formerly ...
Posted by Michael Wonder on 23 Feb 2026
Beren Therapeutics announces FDA acceptance of its new drug application for adrabetadex in infantile-onset Niemann-Pick disease type C
23 February 2026 - Beren Therapeutics today announced that the US FDA has accepted for review its new drug application for ...
Posted by Michael Wonder on 23 Feb 2026
Zepbound (tirzepatide), the most prescribed weight management medication in 2025, now available in multi-dose KwikPen
23 February 2026 - Eli Lilly today announced the US FDA approved a label expansion for Zepbound (tirzepatide) to include the ...
Posted by Michael Wonder on 21 Feb 2026
US FDA accepts Teva’s new drug application for olanzapine extended release injectable suspension (TEV-'749) for the once monthly treatment of schizophrenia in adults
20 February 2026 - Teva Pharmaceuticals and Medincell announced today that the US FDA has accepted its new drug application (NDA) ...
Posted by Michael Wonder on 21 Feb 2026
FDA accepts new drug application for Roche’s giredestrant in ESR1 mutated, ER positive advanced breast cancer
20 February 2026 - Roche announced today that the US FDA has accepted the company’s new drug application for giredestrant, an ...
Posted by Michael Wonder on 21 Feb 2026
FDA approves acalabrutinib with venetoclax for chronic lymphocytic leukaemia or small lymphocytic lymphoma
20 February 2026 - On 19 February 2026, the FDA approved acalabrutinib (Calquence, AstraZeneca) tablets and capsules in combination with venetoclax ...
Posted by Michael Wonder on 20 Feb 2026
Savara announces the US FDA filed the Molbreevi biologics license application in auto-immune pulmonary alveolar proteinosis
20 February 2026 - Savara announced the FDA has filed for review the BLA for Molbreevi as a therapy to ...
Posted by Michael Wonder on 20 Feb 2026
Calquence plus venetoclax approved in the US as first all-oral, fixed-duration combination for patients with chronic lymphocytic leukaemia in the 1st-line setting
20 February 2026 - Calquence plus venetoclax demonstrated statistically significant and clinically meaningful improvement in progression-free survival versus chemoimmunotherapy, with 77% ...
Posted by Michael Wonder on 20 Feb 2026
US FDA approves combination treatment of Venclexta (venetoclax) and acalabrutinib for previously untreated patients with chronic lymphocytic leukaemia
20 February 2026 - AbbVie today announced that the US FDA has approved a supplemental new drug application for the combination ...
Posted by Michael Wonder on 20 Feb 2026
One pivotal trial, the new default option for FDA approval — ending the two-trial dogma
18 February 2026 - This Sounding Board announces a new FDA policy that the default requirement for FDA approvals will be ...
Posted by Michael Wonder on 19 Feb 2026
Pilatus Biosciences receives FDA fast track designation for metabolic checkpoint inhibitor PLT012 in hepatocellular carcinoma
19 February 2026 - Pilatus Biosciences today announced that the US FDA has granted fast track designation for PLT012, the ...
Posted by Michael Wonder on 19 Feb 2026
Garetosmab biologics license application accepted for FDA priority review for the treatment of fibrodysplasia ossificans progressiva
19 February 2026 - Regeneron Pharmaceuticals today announced that the US FDA has accepted for priority review the biologics license application ...
Posted by Michael Wonder on 18 Feb 2026
Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) receives US FDA breakthrough therapy designation for patients with advanced head and neck cancer
18 February 2026 - Johnson & Johnson today announced that the US FDA has granted breakthrough therapy designation for subcutaneous amivantamab ...
Posted by Michael Wonder on 18 Feb 2026
Harmony Biosciences receives US FDA approval for Wakix (pitolisant) for the treatment of cataplexy in paediatric narcolepsy
17 February 2026 - Harmony Biosciences today announced that the US FDA has approved its supplemental new drug application for Wakix ...