PharmaMar and Jazz Pharmaceuticals have secured priority review for their synthetic compound lurbinectedin from the US Food and Drug Administration (FDA) for its use in relapsed small cell lung cancer (SCLC).
Ascletis Pharma announces the application for in-house developed Category 1 Drug ASC41 for clinical trials of NASH indication has been accepted by China's National Medical Products Administration (NMPA).
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 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.
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.
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 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 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.
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).
Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for RUXIENCE (rituximab), a potential biosimilar to MabThera (rituximab).
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