Regulation

Bristol-Myers Squibb withdraws European application of Opdivo plus Yervoy for first-line treatment of advanced NSCLC

Bristol-Myers Squibb Company (NYSE:BMY) today announced that the company has withdrawn its application in the European Union (EU) for the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of advanced non-small cell lung cancer (NSCLC) based on data from CheckMate -227.

Pfizer receives positive CHMP opinion for oncology biosimilar RUXIENCE

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).

Pulmatrix receives fast track designation for Pulmazole for the treatment of Asthma-ABPA

Pulmatrix, Inc. (NASDAQ: PULM) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PUR1900 ("Pulmazole"), the Company's inhaled itraconazole antifungal candidate being developed to treat allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma.

Aprea Therapeutics gets FDA breakthrough therapy status for APR-246 in MDS

Aprea Therapeutics has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its lead molecule APR-246 in combination with chemotherapy drug azacitidine in myelodysplastic syndromes (MDS).

Lilly’s selpercatinib gets FDA priority review for lung and thyroid cancers

Eli Lilly and Company (Lilly) has secured priority review from the US Food and Drug Administration (FDA) for its oral RET inhibitor selpercatinib (LOXO-292) to treat patients with certain types of lung and thyroid cancers.

European Medicines Agency validates Kite’s marketing application for second CAR T cell therapy

Kite, a Gilead Company announced that the company’s Marketing Authorization Application (MAA) for KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), has been fully validated and is now under evaluation by the European Medicines Agency (EMA).

FDA approves Merck’s DIFICID to treat Clostridioides difficile in children aged six months and older

Merck, known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for DIFICID® (fidaxomicin) for oral suspension, and a supplemental New Drug Application (sNDA) for DIFICID tablets for the treatment of Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD) in children aged six months and older.

Epizyme gets FDA approval for Tazverik to treat epithelioid sarcoma

Epizyme has secured accelerated approval from the US Food and Drug Administration (FDA) for its Tazverik (tazemetostat) to treat pateints epithelioid sarcoma.

Jazz Pharmaceuticals submits NDA for JZP-258 for cataplexy and excessive daytime sleepiness associated with narcolepsy

Jazz Pharmaceuticals announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration on January 21, 2020 seeking marketing approval for JZP-258, an investigational medicine for the treatment of cataplexy and excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.