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FDA Accepts and Grants Priority Review to Pfizer’s Tafamidis for Treatment of Transthyretin Amyloid Cardiomyopathy

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today that the US Food and Drug Administration (FDA) accepted for filing the company’s New Drug Applications (NDAs) for tafamidis for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). Pfizer has submitted two NDAs based on two forms of tafamidis: meglumine salt and free …

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FDA Grants Breakthrough Device Designation to AWAK Technologies’ Wearable Peritoneal Dialysis Device

SINGAPORE, Jan. 11, 2019 /PRNewswire/ — AWAK Technologies (AWAK), a pioneering medical technology company focused on dialysis using regeneration technology for end-stage renal disease, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation to its AWAK Peritoneal Dialysis (AWAK PD) device, a wearable and …

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ArcherDX’s Companion Diagnostic Assay for both Liquid Biopsy and Tissue Specimens Granted Breakthrough Device Designation by the FDA

BOULDER, CO-ArcherDX, Inc., a molecular technology company dedicated to developing breakthrough solutions that advance the application of personalized genomic medicine, today announced that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Device designation (formerly Expedited Access Pathway program) for ArcherDx’s companion diagnostic assay application. The FDA’s Breakthrough Device …

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FDA Grants Breakthrough Therapy Designation to Novartis’ Crizanlizumab for the Prevention of Vaso-Occlusive Crises in Sickle Cell Disease

Basel, January 8, 2019 – Novartis announced today that the US Food and Drug Administration (FDA) has granted crizanlizumab (SEG101) Breakthrough Therapy designation for the prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD). Also known as sickle cell pain crises, VOCs are unpredictable and extremely …

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CRISPR Therapeutics and Vertex Announce FDA Fast Track Designation for CTX001 for the Treatment of Sickle Cell Disease

UG, Switzerland and CAMBRIDGE, Mass. and BOSTON, Jan. 04, 2019 (GLOBE NEWSWIRE) — CRISPR Therapeutics (NASDAQ:CRSP) and Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for CTX001 for the treatment of sickle cell disease (SCD). CTX001 is an investigational, autologous, …

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FDA Grants Breakthrough Therapy Designation for Aadi Bioscience’s Tarzifyx in PEComa Indication

PACIFIC PALISADES, Calif.–(BUSINESS WIRE)–Aadi Bioscience, Inc. (Aadi), a clinical stage biopharmaceutical company focused on treating diseases driven by mTOR activation, today announced that its drug TARZIFYX™ (sirolimus albumin-bound nanoparticles for injectable suspension, ABI-009) has received Breakthrough Therapy Designation status from the FDA for the indication of Advanced (metastatic or locally …

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Bristol-Myers Squibb’s Sprycel Tablets Receives FDA Approval in Combination with Chemotherapy in Pediatric Patients with Ph+ Acute Lymphoblastic Leukemia

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has expanded the indication for Sprycel® (dasatinib) tablets to include the treatment of pediatric patients one year of age and older with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy.1  Sprycel is the only …

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ProQR’s QR-421a Receives Fast Track Designation from the FDA for Treatment of Usher Syndrome Type 2

LEIDEN, Netherlands & CAMBRIDGE, Mass., Jan. 02, 2019 (GLOBE NEWSWIRE) — ProQR Therapeutics N.V. (Nasdaq:PRQR), a company dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe genetic rare diseases, today announced that it received Fast Track designation from the Food and Drug Administration …

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FDA Grants Priority Review Designation for Heron’s HTX-011, a Non-Opioid for Postoperative Pain Management

SAN DIEGO, Dec. 31, 2018 /PRNewswire/ — Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for Heron’s …

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FDA Expands Approval of Horizon’s Ravicti Oral Liquid for Use in Newborns Living with Urea Cycle Disorder

DUBLIN–(BUSINESS WIRE)–Horizon Pharma plc (NASDAQ: HZNP) today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) to expand the age range for RAVICTI® (glycerol phenylbutyrate) Oral Liquid to include infants younger than two months of age living with a urea cycle disorder (UCD). …

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