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Industry Dynamics

Industry News

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……

05-27

2024

Atara Biotherapeutics Submits Tabelecleucel (Tab-cel?) Biologics License Application for Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease with U.S. FDA

May 20, 2024-Atara Biotherapeutics, Inc. announced today that Atara has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tabelecleucel (tab-cel?) indicated as monotherapy……

05-13

2024

Verona Pharma Announces $650 Million Strategic Financing with Oaktree and OMERS

May 22,2024-Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), announces it and its wholly-owned subsidiary, Verona Pharma, Inc. (“VPI” and together with Verona Pharma, the “Company”), have entered into strategic financ……

04-22

2024

FDA approves Roche’s Alecensa as the first adjuvant treatment for people with ALK-positive early-stage lung cancer

April 29, 2024-Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Alecensa? (alectinib) for adjuvant treatment following tumour resection for patients with an……

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