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RSS FeedPosted 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 ...
Posted by Michael Wonder on 18 Feb 2026
Sandoz receives US FDA approval to expand Enzeevu (aflibercept-abzv) label for multiple retinal indications
18 February 2026 - Sandoz today announced that the US FDA has approved an expanded label for Enzeevu (aflibercept-abzv), to include ...
Posted by Michael Wonder on 18 Feb 2026
Deciphera Pharmaceuticals announces US FDA acceptance for filing of new drug application for tirabrutinib in patients with relapsed or refractory PCNSL
17 February 2026 - Deciphera Pharmaceuticals today announced that the US FDA has accepted for filing the new drug application under ...
Posted by Michael Wonder on 17 Feb 2026
Acrotech Biopharma announces FDA approval of Adquey (difamilast 1%) ointment for the treatment of mild to moderate atopic dermatitis
13 February 2026 - Acrotech Biopharma, in collaboration with Otsuka, today announces that the US FDA has approved the new ...
Posted by Michael Wonder on 17 Feb 2026
FDA approves Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month
17 February 2026 - Johnson & Johnson today announced the US FDA has approved a new, simplified monthly dosing schedule for ...
Posted by Michael Wonder on 17 Feb 2026
US FDA accepts Bristol Myers Squibb's new drug application for iberdomide in patients with relapsed or refractory multiple myeloma
17 February 2026 - Bristol Myers Squibb today announced that the US FDA has accepted a new drug application for ...
Posted by Michael Wonder on 13 Feb 2026
Disc Medicine receives complete response letter from FDA for bitopertin for the treatment of EPP
13 February 2026 - Disc Medicine announced that the US FDA today issued a complete response letter for the new drug ...