Regulation

FDA approves Pfizer’s Braftovi plus cetuximab to treat BRAFV600E-mutant metastatic CRC

Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Braftovi (encorafenib) plus cetuximab (Erbitux) to treat BRAFV600E-mutant metastatic colorectal cancer (CRC) after prior therapy.

Alnylam seeks FDA approval for lumasiran in primary hyperoxaluria type 1

Alnylam Pharmaceuticals has filed an application with the US Food and Drug Administration (FDA) seeking the latter’s approval for lumasiran for the treatment of primary hyperoxaluria type 1 (PH1).

Beam Therapeutics licenses SIRION Biotech’s LentiBOOST Technology for its CAR-T pipeline

SIRION Biotech announced that Beam Therapeutics licensed rights to use SIRION Biotech’s LentiBOOST for use in their CAR-T cell products.

Takeda gets EU approval for ALUNBRIG in ALK+ NSCLC

Takeda Pharmaceutical has secured expanded approval for ALUNBRIG (brigatinib) in the European Union (EU) to use the tyrosine kinase inhibitor for the treatment of a particular lung cancer population.

IVERIC bio announces fast track designation from US FDA for Zimura to treat geographic atrophy secondary to dry age-related macular degeneration

IVERIC bio announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, in development for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).

Bristol Myers Squibb, Acceleron get FDA nod for Reblozyl to treat anaemia with lower-risk MDS

Bristol Myers Squibb (BMS) and Acceleron Pharma have secured approval from the US Food and Drug Administration (FDA) for Reblozyl (luspatercept-aamt) to treat anaemia in adults with lower-risk myelodysplastic syndromes (MDS).

Bristol Myers Squibb and bluebird bio submit BLA for Idecabtagene Vicleucel to FDA

Bristol Myers Squibb and bluebird bio submitted their Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for idecabtagene vicleucel (ide-cel; bb2121) for the treatment of adults with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.

IMFINZI (durvalumab) approved in the US for extensive-stage small cell lung cancer

AstraZeneca announced that IMFINZI (durvalumab) has been approved in the US as a 1st-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard-of-care (SoC) chemotherapies, etoposide and either carboplatin or cisplatin (platinum-etoposide).

FDA accepts Roche’s NDA for Xofluza to treat influenza in children

Roche announced that the US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) as well as two supplemental New Drug Applications (sNDA) for Xofluza (baloxavir marboxil).