Coherus BioSciences, Inc. announced that it has entered into an asset purchase agreement dated December 2, 2024, with Intas Pharmaceuticals Ltd. for the divestiture of the Udenyca (pegfilgrastim-cbqv)… read more.
GSK plc and Medicines for Malaria Venture (MMV) announced that the World Health Organization (WHO) has awarded prequalification to tafenoquine, the first single-dose medicine for the prevention of… read more.
Biocon Biologics Ltd , a fully integrated global biosimilars company and subsidiary of Biocon Ltd, announced that the FDA has approved Yesintek (ustekinumab-kfce), a biosimilar to the reference… read more.
Zimmer Biomet Holdings, Inc. announced FDA Premarket Approval Application (PMA) Supplement approval for the Oxford Cementless Partial Knee. The approval is based on safety and effectiveness data from… read more.
The FDA is investigating reports of patients developing blood cancer after receiving bluebird bio’s gene therapy Skysona (elivaldogene autotemcel) and is evaluating the need for “further regulatory… read more.
Edwards Lifesciences announced one-year data highlighting the continued outstanding performance of its SAPIEN 3 Ultra RESILIA valve. The data were presented at PCR London Valves 2024 and simultaneously… read more.
GSK plc announced that the European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (Meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine)… read more.
Zai Lab and Pfizer announced a strategic collaboration for the novel antibacterial drug Xacduro (sulbactam-durlobactam) in mainland China. Pfizer’s affiliated companies will be exclusively authorized to undertake and… read more.
NICE (UK) 1.1Teclistamab is recommended as an option for treating relapsed and refractory multiple myeloma in adults, only after 3 or more lines of treatment (including an immunomodulatory… read more.
Medtronic plc announced FDA clearance for its new InPen app featuring missed meal dose detection, paving the way for the launch of its Smart MDI system with the Simplera… read more.
Bayer announced that the FDA has accepted the company’s supplemental new drug application (sNDA) for the oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) in combination with androgen deprivation… read more.
Autolus Therapeutics plc an early-commercial stage biopharmaceutical company developing next-generation programmed T cell therapies, announces the FDA has granted marketing approval for Aucatzyl (obecabtagene autoleucel) for the… read more.
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