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Bio-Techne’s ExoDx Prostate IntelliScore Test Receives Breakthrough Device Designation from the FDA

MINNEAPOLIS, June 17, 2019 /PRNewswire/ — Bio-Techne today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its ExoDx Prostate IntelliScore (EPI) test, making it the first exosome-based liquid biopsy test to receive a Breakthrough Device Designation. This designation not only validates the clinical …

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Blueprint Medicines Submits NDA to the FDA for Avapritinib for the Treatment of PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST

CAMBRIDGE, Mass., June 14, 2019 /PRNewswire/ — Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for avapritinib for the treatment of …

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FDA Approves Amgen and Allergan’s Kanjinti, a Biosimilar to Herceptin

THOUSAND OAKS, Calif., June 13, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved KANJINTI™ (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab):  for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. “The FDA approval of KANJINTI is …

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Catalyst Pharmaceuticals Files a Federal Lawsuit Against the FDA Over Approval of Firdapse Competitor in LEMS

CORAL GABLES, Fla., June 12, 2019 (GLOBE NEWSWIRE) — Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq:CPRX), today announced it has filed a suit against the U.S. Food and Drug Administration (FDA) and several related parties challenging the recent approval of a new drug application and related drug labeling for Jacobus Pharmaceutical Company’s …

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Genentech’s Rituxan Receives Priority Review from the FDA for Treatment of Children with Two Rare Blood Vessel Disorders

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

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FDA Grants Orphan Drug and Rare Pediatric Disease Designation for Denali’s DNL310 for Treatment of Hunter Syndrome

SOUTH SAN FRANCISCO, Calif., June 11, 2019 (GLOBE NEWSWIRE) — Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates for neurodegenerative diseases, today announced that the FDA granted Orphan Drug Designation (“ODD”) and Rare Pediatric Disease Designation for Denali’s DNL310 program, which Denali is …

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Ziopharm Oncology Announces FDA Clearance of IND for Sleeping Beauty TCR-T Cell Therapy Trial at NCI

BOSTON, June 11, 2019 (GLOBE NEWSWIRE) — Ziopharm Oncology, Inc. (“Ziopharm” or “the Company”) (Nasdaq:ZIOP) announced that the investigational new drug (IND) application submitted by the National Cancer Institute (NCI) has received clearance from the U.S. Food and Drug Administration (FDA) for a clinical trial in solid tumors to evaluate T-cell …

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FDA Expands Approval of Merck’s Keytruda for Two New Indications

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) or in combination with platinum and fluorouracil …

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FDA Grants Accelerated Approval of Genentech’s Polivy for Treatment of Patients with Previously Treated Aggressive Lymphoma

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 granted accelerated approval to Polivy™ (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan® (rituximab) (BR) for the treatment of adults with relapsed or refractory …

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FDA Expands Approval of PTC Therapeutics’ Emflaza to Include Duchenne Muscular Dystrophy Patients 2-5 Years of Age

SOUTH PLAINFIELD, N.J., June 7, 2019 /PRNewswire/ — PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the U.S. Food and Drug Administration (FDA) approved the company’s supplemental New Drug Application (sNDA) for Emflaza® (deflazacort) to expand its labeling to include patients with Duchenne muscular dystrophy who are between 2- and 5-years-old. Duchenne is a rare childhood …

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