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).
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).
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.
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.
The Janssen Pharmaceutical Companies of Johnson & Johnson has applied to the European Medicines Agency (EMA) seeking the approval of Imbruvica (ibrutinib) in combination with rituximab as first-line treatment in previously untreated chronic lymphocytic leukaemia (CLL).
Bristol-Myers Squibb announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
ViiV Healthcare has completed a regulatory filing in Europe seeking the approval for fostemsavir for the treatment of HIV-1 infection in adult patients having limited treatment options.
Alnylam Pharmaceuticals has initiated a rolling submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase for the treatment of primary hyperoxaluria type 1 (PH1).
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