Roche announced that the European Commission has approved the extension of the Evrysdi (risdiplam) European Union (EU) marketing authorisation to include infants with a clinical diagnosis of SMA… read more.
Gilead Sciences, Inc. announced that the FDA approved a supplemental new drug application (sNDA) for the use of Veklury (remdesivir) with no dose adjustments to treat COVID-19 in… read more.
Pfizer announced that the European Commission (EC) has granted marketing authorization for Abrysvo, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to help protect both… read more.
BioMarin Pharmaceutical Inc. announced that an individual in Germany with severe hemophilia A was treated with Roctavian (valoctocogene roxaparvovec-rvox), marking the first time that the gene therapy has… read more.
Pfizer Inc. and Astellas Pharma Inc. announced that the FDA has accepted and granted Priority Review for the companies’ supplemental New Drug Application (sNDA) for Xtandi (enzalutamide) for… read more.
GSK announced positive results from the first-ever efficacy trial of Shingrix (Recombinant Zoster Vaccine or RZV) in China. These results come from the post-license phase IV trial (ZOSTER-076),… read more.
Kyowa Kirin Co., Ltd. announces that the company has received approval from the Ministry of Health, Labour and Welfare (“MHLW”) for partial change of approved indication of Lumicef… read more.
Medtronic plc has received CE (Conformité Européenne) Mark approval for its Inceptiv closed-loop rechargeable spinal cord stimulator (SCS). It is the first Medtronic SCS device to offer a… read more.
Innovent Biologics announces that China’s National Medical Products Administration (NMPA) has approved Sintbilo (tafolecimab injection, anti-PCSK9 monoclonal antibody) for the treatment of adult patients with primary hypercholesterolemia (including… read more.
AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisolone has been approved in Japan for the treatment of adult patients with BRCA-mutated (BRCAm) castration-resistant prostate cancer… read more.
Revance Therapeutics, Inc. announced that the FDA has approved the first therapeutic indication for Daxxify (daxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia in adults. Daxxify, powered… read more.
Forxiga (dapagliflozin) from AstraZeneca. has been approved in China to reduce the risk of cardiovascular death, hospitalisation for heart failure (HF), or urgent HF visits in adults with… read more.
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