The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Rozlytrek (entrectinib), from… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Rozlytrek (entrectinib), from… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Xenleta (lefamulin), from Nabriva… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Lynparza… read more.
Eli Lilly and Company announced that the FDA has approved Cyramza (ramucirumab injection, 10 mg/mL solution), in combination with erlotinib, for the first-line treatment of people with metastatic… read more.
The EMA’s CHMP has recommended granting a marketing authorisation in the European Union for a new Ebola vaccine Zabdeno (formerly Ad26.ZEBOV) + Mvabea (formerly MVA-BN-Filo), from Janssen-Cilag International,… read more.
Minerva Neurosciences, Inc., a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, announced that the Phase III trial of roluperidone to… read more.
Detailed results from the positive, registrational, randomised controlled Phase II DESTINY-Gastric01 trial showed AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) demonstrated a statistically significant… read more.
Menlo Therapeutics announced that the FDA has approved Zilxi (minocycline) topical foam, 1.5%, for the treatment of inflammatory lesions of rosacea in adults. Zilxi, developed as FMX103 by… read more.
Novartis has announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of Piqray (alpelisib) in… read more.
Myovant Sciences announced additional results from its Phase III HERO study of once-daily, oral TAK 385 (relugolix) (120 mg) in men with advanced prostate cancer in an oral… read more.
Santhera Pharmaceuticals announces that the CHMP has granted a requested extension of the clock-stop in the regulatory procedure for its conditional marketing authorization (CMA) application for Puldysa (idebenone)… read more.
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