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Krystal Biotech secures approval in Japan for genetic therapy VYJUVEK to treat dystrophic epidermolysis bullosa
25 July 2025 - Commercial-stage biotechnology company Krystal Biotech Inc (NASDAQ:KRYS) announced on Friday that Japan's Ministry of Health, Labour and Welfare has approved VYJUVEK for the treatment of wounds in patients with dystrophic epidermo...
Pfizer and BioNTech receive EU regulatory backing for LP.8.1-adapted COVID-19 vaccine
25 July 2025 - US biopharmaceutical company Pfizer Inc (NYSE:PFE) and German biotechnology company BioNTech SE ADR (NASDAQ:BNTX) have received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use...
Gilead receives positive CHMP opinions for lenacapavir as first twice-yearly HIV prevention option in EU
25 July 2025 - Biopharmaceutical company Gilead Sciences Inc (Nasdaq:GILD) announced on Friday that it has received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency under accelerated review f...
Sanofi secures EU approval for Sarclisa in newly diagnosed transplant-eligible multiple myeloma
25 July 2025 - French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Friday that it has received European Commission approval for Sarclisa in combination with bortezomib, lenalidomide and dexamethasone (VRd) as inductio...
Pierre Fabre Pharmaceuticals reports FDA acceptance and Priority Review of Biologics License Application for tabelecleucel
25 July 2025 - French pharmaceutical company Pierre Fabre Pharmaceuticals Inc (PFP) announced on Thursday the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted Priority Review for tabelecleucel, in...