PHARMASHOTS NEWSWIRE

Merck Receives Positive EU CHMP Opinion for KEYTRUDA (pembrolizumab) Plus Padcev (enfortumab vedotin-ejfv) as First-Line Treatment for Patients With Unresectable or Metastatic Urothelial Carc

26 Jul 2024

Regulatory

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s a

Calliditas announces positive TRANSFORM Phase 2b topline data in primary biliary cholangitis

26 Jul 2024

Clinical Trials

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the Phase 2b TRANSFORM trial met its primary endpoint, showing statistically significant improvement in ALP (Alkaline Phosphatase) for both doses tested versus placebo.  The trial

LEO Pharma Receives Positive CHMP Opinion of Anzupgo (delgocitinib cream) for the Treatment of Adults with Moderate to Severe Chronic Hand Eczema (CHE)

26 Jul 2024

Regulatory

BALLERUP, Denmark, July 26, 2024 -- LEO Pharma A/S, a global leader in medical dermatology, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion that recommends the approval of Anzupgo® (delgoci

AbbVie Announces European Commission Approval of SKYRIZI (risankizumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

26 Jul 2024

Regulatory

NORTH CHICAGO, Ill., July 26, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Commission has approved SKYRIZI® (risankizumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate r

U.S. FDA Approves LEQSELVI (deuruxolitinib), an Oral JAK Inhibitor for the Treatment of Severe Alopecia Areata

26 Jul 2024

Regulatory

MUMBAI, India and PRINCETON, N.J., July 25, 2024 – Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries or associate companies) today announced that the U.S. Food and Drug Administration

European Commission Approves Pfizer’s DURVEQTIX (fidanacogene elaparvovec), a One-Time Gene Therapy for Adults with Hemophilia B

26 Jul 2024

Regulatory

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted conditional marketing authorization for DURVEQTIX® (fidanacogene elaparvovec), a gene therapy for the treatment of severe and moderately severe hemophilia B (congenita



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