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RSS FeedPosted 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 26 Feb 2026
FDA grants accelerated approval to zongertinib for unresectable or metastatic non-squamous non-small cell lung cancer
26 February 2026 - Today, the FDA granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals), a kinase inhibitor, for ...
Posted by Michael Wonder on 25 Feb 2026
Siren Biotechnology receives FDA fast track designation for SRN-101 for the treatment of recurrent high grade glioma
24 February 2026 - Siren Biotechnology today announced that the US FDA has granted fast track designation to SRN-101, the ...
Posted by Michael Wonder on 25 Feb 2026
Aktis Oncology receives US FDA fast track designation for AKY-1189, a nectin-4 miniprotein radioconjugate
24 February 2026 - Aktis Oncology today announced that the US FDA has granted fast track designation to AKY-1189 for the ...
Posted by Michael Wonder on 24 Feb 2026
FDA grants traditional approval to encorafenib for metastatic colorectal cancer with a BRAF V600E mutation
24 February 2026 - Today, the FDA granted traditional approval to encorafenib (Braftovi, Array BioPharma, a subsidiary of Pfizer) in ...
Posted by Michael Wonder on 24 Feb 2026
Artios receives US FDA fast track designation for DNA polymerase theta inhibitor ART6043 for treatment of gBRCA-mutated HER2 negative breast cancer
23 February 2026 - Artios Pharma today announced that the US FDA granted fast track designation to its potentially first ...
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
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 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 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
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
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 ...