Valneva SE announced that the EMA will lift the temporary restriction on vaccinating people aged 65 years and above after concluding a systematic review of Valneva’s single-dose chikungunya… read more.
Moderna Inc. announced that the FDA has approved the supplemental Biologics License Applications (sBLA) for the 2025-2026 formulas for Spikevax and mNEXSPIKE, targeting the LP.8.1 variant of SARS-CoV-2… read more.
Eli Lilly and Company announced positive topline results from the primary overall survival (OS) analysis of the Phase III monarchE trial. Treatment with two years of Verzenio plus… read more.
Boehringer Ingelheim’s Hernexeos (zongertinib tablets) has been approved as monotherapy by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with unresectable, locally advanced or… read more.
Tonix Pharmaceuticals Holding Corp. announced that the FDA approved Tonmya (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults. Tonmya is a first-in-class, non-opioid, once-daily bedtime analgesic… read more.
Alvotech and Advanz Pharma announced that the European Commission has approved Mynzepli as a biosimilar to Eylea (aflibercept), in a pre-filled syringe and vial. The centralized marketing authorization… read more.
Novavax, Inc. announced that the FDA has approved the Nuvaxovid 2025-2026 Formula for the prevention of COVID-19 in individuals 65 years of age and older, or 12 years… read more.
Agios Pharmaceuticals Inc. announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Application (sNDA) of Pyrukynd (mitapivat), an… read more.
Shionogi & Co., Ltd. announced the FDA has accepted for review a New Drug Application (NDA) from Shionogi Inc., its US subsidiary for ensitrelvir (Xocova, enensitrelvir fumaric acid,… read more.
Medtronic plc announced two FDA regulatory milestones that broaden the MiniMed 780G system portfolio: clearance of the SmartGuard algorithm as an interoperable automated glycemic controller (iAGC), enabling integration… read more.
Novartis announced positive results from V-DIFFERENCE, a Phase IV study evaluating Leqvio (inclisiran) compared to placebo, both administered on top of individually optimized lipid-lowering therapy (LLT), in patients… read more.
Abbott announced it has received CE Mark in Europe for an expanded indication for the company’s Navitor transcatheter aortic valve implantation (TAVI) system to treat people with symptomatic,… read more.
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