Cytokinetics, Incorporated announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted MYQORZO (aficamten) a marketing authorisation across the United Kingdom for the treatment of symptomatic… read more.
AbbVie announced that the European Commission approved Maviret (glecaprevir/pibrentasvir), an oral pangenotypic direct-acting antiviral (DAA) therapy for the treatment of acute hepatitis C viru infection in adults and… read more.
Pfizer and BioNTech SE announced that the European Commission has granted marketing authorization for the companies’ 2026-2027 COVID-19 vaccine formula, targeting the XFG variant, for active immunization to… read more.
AstraZeneca’s Etcamah (camizestrant) in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) has been approved in the European Union for the treatment of adult… read more.
Nuvectis Pharma announced that ciprocopan (NXP100), a once-daily oral complement Factor B inhibitor, received marketing approval from the National Medicinal Products Administration of China (NMPA) for the treatment… read more.
Teleflex Incorporated announced it has received Biologics License Application (BLA) approval for Ezplaz Freeze Dried Plasma (FDP) from the U.S. Food and Drug Administration (FDA). Ezplaz FDP is… read more.
Merck, known as MSD outside of the United States and Canada, announced the FDA has approved Lipfendra (enlicitide) tablets 20 mg as an adjunct to diet and exercise… read more.
Incyte announced that the EC has approved Opzelura (ruxolitinib) cream for the treatment of moderate atopic dermatitis (AD) in adult patients for whom topical corticosteroids (TCSs) and topical… read more.
Zevra Therapeutics announced that the CHMP has adopted a negative opinion regarding the Marketing Authorization Application (MAA) for arimoclomol for the treatment of Niemann-Pick disease type C (NPC),… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation in the EU for the medicinal product Icotyde (icotrokinra), intended for… read more.
Boehringer Ingelheim announced that the European Commission (EC) has granted marketing authorization for Jascayd (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and adults with… read more.
Eisai Co., Ltd. and Biogen Inc. announced that the FDA has approved a supplemental Biologics License Application (sBLA) for a once-weekly lecanemab-irmb subcutaneous injection (brand name: Leqembi IQLIK)… read more.
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