Pharmaceuticals, Biotechnology and Life Sciences
AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) is authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) and is the first antibody combination for pre-exposure prophylaxis (PrEP) against COVID-19 licensed in Great Britain.
Further positive results from the OlympiA Phase III trial showed AstraZeneca and MSD’s Lynparza (olaparib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo in the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer who had completed local treatment and standard neoadjuvant or adjuvant chemotherapy.
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for AstraZeneca’s Fasenra (benralizumab) for patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
Valneva SE has provided an update on the regulatory review of its inactivated, COVID-19 vaccine candidate, VLA2001, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
National Health Regulatory Authority (NHRA) of the Kingdom of Bahrain has granted emergency use authorization for Valneva’s inactivated, adjuvanted COVID-19…
Sobi has announce that the Center for Drug Evaluation (CDE) has recommended approval of Gamifant to the National Medical Products…
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, has announced that the Committee for Medicinal Products for…
Idorsia Ltd has announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European…
Bristol Myers Squibb (NYSE: BMY) has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics…
AstraZeneca’s Saphnelo (anifrolumab) has been approved in the European Union as an add-on therapy for the treatment of adult patients with moderate…