The European Medicines Agency (EMA) has unveiled a series of initiatives designed to address low representation of women in clinical trials and gaps in understanding sex-based differences in… 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.
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.
AstraZeneca withdrew its application for the use of Imfinzi (durvalumab) in combination with BCG in the treatment of high-risk non-muscle invasive bladder cancer (NMIBC), a type of cancer… 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.
Gilead Sciences announced that the CHMP of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy (sacituzumab govitecan-hziy) in combination with… read more.
Many countries are using too many powerful and inappropriate antibiotics, fuelling antibiotic resistance concerns, while millions lack access to the specific drugs they need. That is according to… read more.
Roche announced that the CHMP has recommended the approval of Susvimo (ranibizumab injection) 100 mg/mL for the treatment of neovascular age-related macular degeneration (nAMD). Susvimo is intended for… read more.
Chiesi announces MHRA approval in the UK of Clenil Modulite (beclometasone; 100 mcg and 200 mcg) formulated with a next-generation, non-PFAS, low GWP propellant. These are the first… read more.
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