Industry Dynamics

Industry News

10-22

2024

Gepotidacin accepted for priority review by US FDA for treatment of uncomplicated urinary tract infections in female adults and adolescents

October 27, 2024 – GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for gepotidacin, an investigational, first-in-class oral antibiotic with a n……

10-16

2024

FDA Approves Pfizer's New Treatment for Hemophilia

October 22, 2024 – The U.S. Food and Drug Administration approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 22 years of ag……

09-27

2024

European Commission Approves LEO Pharma’s Anzupgo® (delgocitinib) Cream for Adults with Moderate to Severe Chronic Hand Eczema (CHE)

September 24, 2024 – LEO Pharma A/S, a global leader in medical dermatology, today announced that the European Commission (EC) has granted marketing authorization for Anzupgo® (delgocitinib) cream for the treatment of ad……

09-14

2024

DUPIXENT® (DUPILUMAB) APPROVED IN THE U.S. AS FIRST AND ONLY TREATMENT FOR ADOLESCENTS WITH CHRONIC RHINOSINUSITIS WITH NASAL POLYPS (CRSWNP)

September 23, 2024 -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) as an add-on maintenance treatment for a……

08-29

2024

European Commission approves BALVERSA®▼ (erdafitinib) for adult patients with unresectable or metastatic urothelial carcinoma

August 24, 2024 – Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the European Commission (EC) has approved BALVERSA®▼(erdafitinib) as a once-daily oral monotherapy for the treatment of ……

08-13

2024

FDA Approves First Nasal Spray for Treatment of Anaphylaxis

August 9, 2024 -- ARS Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those……

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