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.
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 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).
Aimmune Therapeutics has secured approval for Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] from the US Food and Drug Administration (FDA) to treat patients with peanut allergy.
Bristol-Myers Squibb Company (NYSE:BMY) today announced that the company has withdrawn its application in the European Union (EU) for the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of advanced non-small cell lung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 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, 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 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).
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