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.
NICE (UK): Cemiplimab can be used as an option to treat recurrent or metastatic cervical cancer that has progressed on or after platinum-based chemotherapy in adults if: i)… read more.
Eton Pharmaceuticals, Inc announced that the Company’s new formulation of Khindivi (hydrocortisone) oral solution successfully showed bioequivalence to Alkindi Sprinkle (hydrocortisone) oral granules, the FDA-approved hydrocortisone granule formulation,… 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.
Sanofi withdrew its application for the use of Dupixent (dupilumab) in the treatment of adults with moderate-to-severe bullous pemphigoid, an autoimmune skin disease causing widespread itching and blisters… 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.
Roche announced that its Elecsys IGRA TB test has received the CE Mark, introducing a new blood testing solution for identifying tuberculosis infection (TBI, also known as latent… 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.
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