FDA News

Agenus Receives FDA Fast Track Designation for Balstilimab in Advanced Cervical Cancer

LEXINGTON, Mass., April 7, 2020 /PRNewswire/ — Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Agenus Fast Track designation for investigation of balstilimab (anti-PD-1) for the treatment of …

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Alnylam Completes Rolling Submission of NDA to the FDA and Submits MAA to the EMA for Lumasiran for the Treatment of Primary Hyperoxaluria Type 1

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase (GO), in development for the treatment of primary …

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FDA Grants Priority Review to Merck’s Application for Keytruda Based on Biomarker, Regardless of Tumor Type

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 accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy. The application seeks accelerated approval of KEYTRUDA …

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FDA Grants Fast Track Designation to Blaze’s BLZ-100 for Pediatric Central Nervous System Tumors

SEATTLE–(BUSINESS WIRE)–Blaze Bioscience, Inc., the Tumor Paint Company®, a biotechnology company dedicated to improving the lives of cancer patients through development and commercialization of products for fluorescence guided surgery, announced today that its clinical program evaluating tozuleristide (BLZ-100) for pediatric brain tumors, has been granted Fast Track designation from the U.S. …

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HEMA Biologics Announces FDA Approval of SEVENFACT for Treatment of Bleeding Episodes in Hemophilia A and B Patients with Inhibitors

HEMA Biologics, LLC, (“HEMA Biologics”) today announced that the U.S. Food and Drug Administration (FDA) approved SEVENFACT® [coagulation factor VIIa (recombinant)-jncw] as the first new bypassing agent in over 20 years for adults and adolescents (12 years of age and older) with hemophilia A and B with inhibitors. “Through a joint …

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FDA Approves Reblozyl for Treatment of Anemia in Adults with Lower-Risk Myelodsyplastic Syndromes

PRINCETON, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced the U.S. Food and Drug Administration (FDA) has approved Reblozyl® (luspatercept-aamt), the first and only erythroid maturation agent (EMA), for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell …

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FDA Coordinates National Effort to Develop Blood-Related Therapies for COVID-19

The U.S. Food and Drug Administration continues to play a critical role in accelerating medical countermeasures to treat and prevent COVID-19. As part of the response to this pandemic, the agency is taking the lead on a national effort to facilitate the development of, and access to, two investigational therapies …

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FDA Approves Lilly’s Taltz for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis

INDIANAPOLIS, March 30, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Taltz® (ixekizumab) injection, 80 mg/mL for the treatment of pediatric patients (ages 6 to under 18) with moderate to severe plaque psoriasis who are candidates for systemic …

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FDA Approves AstraZeneca’s Imfinzi for Treatment of Adults with Extensive-Stage Small Cell Lung Cancer

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced that IMFINZI® (durvalumab) has been approved in the US as a 1st-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard-of-care (SoC) chemotherapies, etoposide and either carboplatin or cisplatin (platinum-etoposide). The approval by the US Food and Drug Administration was …

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FDA Issues Emergency Use Authorization to Thermo Fisher for its TaqPath COVID-19 Combo Kit

Today, the U.S. Food and Drug Administration took another significant diagnostic action during the coronavirus outbreak (COVID-19). The FDA issued the fourth COVID-19 diagnostic Emergency Use Authorization (EUA) to Thermo Fisher for its TaqPath COVID-19 Combo Kit. “This action today shows our agency’s dedication to working around the clock to …

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