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FDA Grants Fast Track Designation to Lilly’s Baricitinib for the Treatment of Systemic Lupus Erythematosus

INDIANAPOLIS, Dec. 13, 2018 /PRNewswire/ — Eli Lilly and Company(NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to baricitinib, which is being studied for the treatment of systemic lupus erythematosus (SLE). The Fast Track designation process aims to facilitate the development and …

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FDA Grants Orphan Drug Designation to Merck KGaA’s Bifunctional Immunotherapy M7824 in Biliary Tract Cancer

DARMSTADT, Germany, December 10, 2018 /PRNewswire/ — FDA grants M7824, an investigational bifunctional immunotherapy, orphan drug designation in biliary tract cancer First regulatory designation for M7824 following recent presentation of first clinical data in BTC BTC is a group of rare, aggressive gastrointestinal cancers associated with limited treatment options and …

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FDA Approves Genentech’s Tecentriq in Combination With Avastin and Chemotherapy for the Initial Treatment of a Specific Type of Metastatic Lung Cancer

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab), in combination with Avastin®(bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer …

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FDA Grants Priority Review to Genentech’s Tecentriq in Combination with Chemotherapy for Initial Treatment of Extensive-Stage Small Cell Lung Cancer

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab), in combination with carboplatin and etoposide (chemotherapy), for the …

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FDA Grants Priority Review to Novartis’ AVXS-101, a One-Time Treatment Designed to Address the Genetic Root Cause of SMA Type 1

Basel, December 3, 2018 – Novartis today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for AVXS-101, now known as ZOLGENSMA® (onasemnogene abeparvovec-xxxx)[1], an investigational gene replacement therapy for the treatment of spinal muscular atrophy (SMA) Type 1. ZOLGENSMA is designed to address the …

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FDA Grants Breakthrough Device Designation to Artificial Intelligence Software for CTEPH Pattern Recognition from Bayer and MSD

Berlin, December 3, 2018 – Bayer announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to the Artificial Intelligence Software for Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Pattern Recognition, which Bayer is currently developing jointly with MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA). A …

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FDA Authorizes First Test to Aid in Detecting Cytomegalovirus in Newborns

Today the U.S. Food and Drug Administration permitted marketing of a new diagnostic test to aid in detecting a type of herpes virus called cytomegalovirus (CMV) in newborns less than 21 days of age. “Although most people who become infected with cytomegalovirus face little to no risk of serious illness, …

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FDA Accepts Editas Medicine’s IND Application for its CRISPR Genome Editing Medicine Being Investigated for Leber Congenital Amaurosis type 10

CAMBRIDGE, Mass., Nov. 30, 2018 (GLOBE NEWSWIRE) —  Editas Medicine, Inc. (NASDAQ: EDIT), a leading genome editing company, today announced the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application for EDIT-101, an experimental CRISPR genome editing medicine being investigated for the treatment of …

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FDA Approves Catalyst’s Firdapse for the Treatment of Lambert-Eaton Myasthenic Syndrome

CORAL GABLES, Fla., Nov. 29, 2018 (GLOBE NEWSWIRE) — Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Firdapse® (amifampridine) 10 mg tablets for the treatment of …

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FDA Approves Astellas’ Xospata for Adults with Relapsed/Refractory Acute Myeloid Leukemia with a FLT3 Mutation

TOKYO, Nov. 28, 2018 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) approved XOSPATA® (generic name: gilteritinib) for the treatment of adult patients who have relapsed or refractory (resistant to treatment) Acute Myeloid Leukemia …

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