Incyte announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Opzelura… read more.
According to the CHMP/EMA website, the Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product… read more.
Viatris Inc. announced that the FDA has approved Gwyn Lo (norelgestromin and ethinyl estradiol transdermal system). Gwyn Lo is a new combined hormonal contraceptive patch with low-dose estrogen…. read more.
Otsuka announced that the FDA has granted approval of SIMTRIYO (centanafadine), a once-daily extended-release capsule for the treatment of attention-deficit hyperactivity disorder in adults and pediatric patients aged… read more.
The European Medicines Agency’s (EMA) key human medicines committee (CHMP) has recommended twelve medicines for approval at its July 2026 meeting. This brings to 54 the number of… read more.
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.
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