Biogen announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation to zuranolone, an oral capsule licensed for the treatment of adult women with… 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.
Arcutis Biotherapeutics Inc. announced the submission of a supplemental New Drug Application (sNDA) to the FDA to expand the indication of Zoryve (roflumilast) ) cream 0.3% for the… read more.
Novo Nordisk presented data from the STEER real-world study of evidence gathered from actual patient experiences at the European Society of Cardiology (ESC) Congress 2025 in Madrid, Spain…. read more.
NICE (UK): Tirzepatide is recommended as an option for managing overweight and obesity, alongside a reduced-calorie diet and increased physical activity in adults, only if they have: i)… read more.
Travere Therapeutics, Inc., announced that the FDA has approved updated Risk Evaluation and Mitigation Strategy (REMS) labeling for Filspari (sparsentan), the only Dual Endothelin Angiotensin Receptor Antagonist for… read more.
Idorsia Ltd announced that its novel dual endothelin receptor antagonist (ERA), Tryvio (aprocitentan), has been included in the new comprehensive clinical practice guidelines for the management of systemic… read more.
NICE(UK): Durvalumab with tremelimumab can be used, within its marketing authorisation, as an option for untreated advanced or unresectable hepatocellular carcinoma (HCC) in adults. Durvalumab with tremelimumab can… read more.
-BioXcel Therapeutics, Inc announced that the SERENITY At-Home Pivotal Phase III trial evaluating the safety of BXCL 501, the Company’s proprietary, sublingual film formulation of dexmedetomidine, as an… read more.
Iterum Therapeutics plc announced the U.S. launch of Orlynvah (sulopenem etzadroxil and probenecid) oral tablets. The FDA had approved Orlynvah for adult women with uncomplicated urinary tract infections… read more.
Gilead Sciences Inc. announced that the European Commission (EC) has granted marketing authorization for Yeytuo (lenacapavir)—the company’s twice-yearly injectable HIV-1 capsid inhibitor—for use as pre-exposure prophylaxis (PrEP) to… read more.
Madrigal Pharmaceuticals Inc. announced that the European Commission (EC) has granted conditional marketing authorization for Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic MASH with moderate to… read more.
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