Industry Dynamics

Industry News

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……

07-25

2024

New data for Roche’s Susvimo demonstrates sustained efficacy in two serious diabetic eye conditions

July 22, 2024 – Roche announced today two-year data from the Phase III Pagoda and Pavilion studies evaluating Susvimo® (Port Delivery System with ranibizumab) for the treatment of diabetic macular edema (DME) and diabeti……

07-12

2024

FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to 6 Years of Age

July 9, 2024 -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for ZORYVE (roflumilast) cream, 0.25%, f……

06-27

2024

HUTCHMED Announces European Commission Approval for FRUZAQLA® (fruquintinib) Received by Takeda

June 22, 2024 -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:23) today announces that its partner Takeda (TSE:4502/NYSE:TAK) has received notification from the European Commission (“EC”) that it has appro……

06-14

2024

FDA grants accelerated approval to selpercatinib for pediatric patients two years and older with RET-altered metastatic thyroid cancer or solid tumors

June 3, 2024 -the Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for pediatric patients two years of age and older with the following:advanced or metastatic me……

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