UCB announced that the FDA has approved a 2 mL pre-filled syringe and pre-filled autoinjector, each containing 320 mg of Bimzelx (bimekizumab-bkzx). These new device presentations add to… read more.
Pfizer Inc. announced positive topline results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor,… read more.
Janssen-Cilag International NV, a Johnson & Johnson company, announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval for an indication… read more.
GE HealthCare announced that the FDA has granted approval of Flyrcado (flurpiridaz F 18) injection, a first of its kind positron emission tomography myocardial perfusion imaging (PET MPI)… read more.
Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol water-free technology, and Laboratoires Théa (Théa), the leading independent eye care group… read more.
GSK plc announced new data from the AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial evaluating the efficacy of a single dose of Arexvy (respiratory syncytial virus vaccine,… read more.
Medtronic plc, a global leader in healthcare technology, voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed 600 series or 700… read more.
Positive high-level results from the BATURA Phase IIIb trial showed AstraZeneca’s Airsupra (albuterol/budesonide) met the primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk… read more.
UCB, announced the first presentation of two-year data from the Phase III studies, BE HEARD I and BE HEARD II, and their open-label extension, evaluating the efficacy and… read more.
Formycon AG and its commercialization partner Fresenius Kabi jointly announce that the European Commission (EC) has issued a marketing authorization for Otulfi, a biosimilar to Stelara. The centralized… read more.
Pfizer and BioNTech SE announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has recommended marketing authorization for the companies’… read more.
AbbVie announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization of mirvetuximab soravtansine… read more.
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