Regulation

Epizyme seeks FDA accelerated approval for Tazverik to treat follicular lymphoma

Epizyme is seeking accelerated approval from the US Food and Drug Administration (FDA) for its Tazverik (tazemetostat) to treat patients with relapsed or refractory follicular lymphoma (FL).

Seattle Genetics gets FDA priority review for tucatinib in locally advanced or metastatic HER2-positive breast cancer

Seattle Genetics announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Company’s New Drug Application (NDA) for the investigational medicine tucatinib.

The US FDA accepts for priority review Bristol-Myers Squibb’s BLA for liso-cel for adult patients with relapsed or refractory large B-cell lymphoma

Bristol-Myers Squibb (BMS) announced that the US Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel), the company’s autologous anti-CD19 chimeric antigen receptor (CAR) T-cell immunotherapy with a defined composition of purified CD8+ and CD4+ CAR T cells for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies.

Roche gets Chinese approval for Tecentriq plus chemotherapy to treat ES-SCLC

Roche has secured approval from the China National Medical Products Administration (NMPA) for Tecentriq (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) as a first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC).

Deciphera Pharmaceuticals announces US FDA acceptance of NDA and priority review for ripretinib in patients with advanced gastrointestinal stromal tumours

Deciphera Pharmaceuticals announced that the US Food and Drug Administration (FDA) has accepted for Priority Review its New Drug Application (NDA) seeking approval for ripretinib, the Company’s investigational broad-spectrum KIT and PDGFRα inhibitor, for the treatment of patients with advanced gastrointestinal stromal tumors (GIST).

Novartis’ capmatinib gets FDA priority review in METex14 mutated advanced NSCLC

Novartis has secured priority review for its MET inhibitor capmatinib (INC280) from the US Food and Drug Administration (FDA) for the treatment of a type of non-small cell lung cancer (NSCLC).

Nanobiotix gets FDA fast track status for NBTXR3 to investigate in head and neck cancer

Nanobiotix has secured fast track designation from the US Food and Drug Administration (FDA) for the investigation of NBTXR3 in head and neck squamous cell cancer.

ReAlta Life Sciences announces FDA orphan drug designation for PIC1 to treat hypoxic-ischemic encephalopathy

ReAlta Life Sciences announced that US Food and Drug Administration (FDA) has granted orphan drug designation to PIC1-dPEG24 for the treatment of hypoxic-ischemic encephalopathy (HIE) in neonates.

Merck gets FDA priority review for Recarbrio in HABP/VABP

Merck has secured priority review from the US Food and Drug Administration (FDA) for Recarbrio (imipenem, cilastatin, and relebactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).