FDA News

FDA Accepts CSL’s BLA for First Subcutaneous Prophylactic Therapy to Prevent HAE Attacks

KING OF PRUSSIA, Pa., Aug. 30, 2016 /PRNewswire/ — CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for its low-volume subcutaneous (SC) C1-Esterase Inhibitor (C1-INH) Human replacement therapy, CSL830, as prophylaxis to prevent Hereditary Angioedema (HAE) …

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FDA Advises Testing for Zika Virus in all Donated Blood and Blood Components in the US

As a further safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories. “There is still much uncertainty regarding the nature and …

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FDA Rejects Amgen’s Next-Generation Chronic Kidney Disease Drug

THOUSAND OAKS, Calif., Aug. 24, 2016 /PRNewswire/ — Amgen (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the New Drug Application (NDA) for Parsabiv™ (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease …

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Clovis Oncology’s Ovarian Cancer Drug Receives Priority Review from the FDA

BOULDER, Colo.–(BUSINESS WIRE)–Aug. 23, 2016– Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has accepted Clovis’ New Drug Application (NDA) for accelerated approval of rucaparib and granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of …

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FDA Allows Marketing of First-of-Kind Computerized Cognitive Tests to Help Assess Cognitive Skills Post-Head Injury

The U.S. Food and Drug Administration today permitted marketing of two new devices to assess a patient’s cognitive function immediately after a suspected brain injury or concussion. The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first medical devices permitted for marketing that are intended to …

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FDA Delays Decision on Sanofi’s Diabetes Drug

Paris, France – August 19, 2016 – Sanofi announced today that it has submitted updated information on the pen delivery device as part of the New Drug Application (NDA) for the investigational once-daily fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of …

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FDA Approves Pfizer’s Extended-Release Abuse-Deterrent Properties for the Management of Pain

Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved TROXYCA® ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules, for oral use, CII for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. TROXYCA …

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FDA Grants Fast Track Designation to Lilly and AstraZeneca’s Investigational Alzheimer’s Disease Drug

INDIANAPOLIS, Aug. 22, 2016 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and AstraZeneca today announced they have received U.S. Food and Drug Administration (FDA) Fast Track designation for the development program in Alzheimer’s disease for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in phase 3 clinical …

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FDA Grants Orphan Drug Status to Soligenix’s Dusquetide for Treatment of Macrophage Activation Syndrome

PRINCETON, N.J., Aug. 18, 2016 /PRNewswire/ — Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products Development of the US Food and …

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Zymeworks Receives Orphan Status from the FDA for Two of its Ovarian Cancer Drugs

VANCOUVER, British Columbia–(BUSINESS WIRE)–Zymeworks Inc., a biopharmaceutical company discovering and developing innovative multi-functional protein-based therapeutics, including bi-specific antibodies and drug conjugates for the treatment of cancer, announced today that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to Zymeworks’ lead investigational products ZW25 and ZW33 …

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