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FDA Grants Clementia’s Palovarotene Rare Pediatric Disease Designation for Fibrodysplasia Ossificans Progressiva

MONTREAL, Feb. 11, 2019 (GLOBE NEWSWIRE) — Clementia Pharmaceuticals Inc. (Nasdaq: CMTA), a clinical-stage biopharmaceutical company innovating treatments for people with ultra-rare bone disorders and other diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to palovarotene for the treatment of fibrodysplasia …

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FDA Approves Grifols’ Procleix Babesia Assay for Donor Screening on Procleix Panther System

BARCELONA, Spain, Feb. 7, 2019 /PRNewswire/ — Grifols, a leading global producer of plasma-derived medicines and a leader in the development of innovative diagnostic solutions, announced today that the U.S. Food and Drug Administration (FDA) approved the Procleix Babesia assay, a qualitative assay for the detection of the ribosomal RNA …

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FDA Extends Review Period for Incyte’s Jakafi in Acute Graft-Versus-Host Disease

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte (Nasdaq:INCY)announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi®) for the treatment of patients with acute graft-versus-host disease (GVHD) who have had an inadequate response to corticosteroids. The new Prescription Drug …

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Sanofi Announces FDA Approval of Cablivi, the First Nanobody-Based Medicine for Patients with a Rare Blood-Clotting Disorder

PARIS – February 6, 2019 – The U.S. Food and Drug Administration (FDA) has approved Cablivi® (caplacizumab-yhdp) in combination with plasma exchange and immunosuppression for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP) in adults.  Cablivi is the first FDA approved therapy specifically indicated for the treatment of aTTP. “The U.S. approval …

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Ampio Updates Status of Osteoarthritis Pivotal Clinical Trial of Ampion to be Carried Out Under a Special Protocol Assessment

ENGLEWOOD, Colo., Feb. 6, 2019 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced it had received an initial response from the U.S. Food and Drug Administration (FDA), Office of Tissue and Advanced Therapies division regarding the Company’s submission of a proposed trial design for the treatment of KL4 …

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Zogenix Submits Fintepla Applications to the FDA and EMA for the Treatment of Dravet Syndrome

EMERYVILLE, Calif., Feb. 06, 2019 (GLOBE NEWSWIRE) — Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced it has completed its rolling submission of a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) and submitted a Marketing Authorization Application (MAA) to the …

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Apellis’ APL-2 Receives Orphan Drug Designation from the FDA for the Treatment of Autoimmune Hemolytic Anemia

CRESTWOOD, Ky., and WALTHAM, Mass., Feb. 05, 2019 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals Inc. (Nasdaq:APLS), a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat diseases through inhibition of the complement system, today announced that its C3 complement inhibitor, APL-2, has been granted orphan drug designation by the U.S. Food …

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FDA Grants Priority Review to Daiichi Sankyo’s CSF1R Inhibitor for Treatment of Patients with Tenosynovial Giant Cell Tumor

TOKYO and MUNICH and BASKING RIDGE, N.J., Feb. 5, 2019 /PRNewswire/ — Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for pexidartinib for the treatment of adult patients with symptomatic tenosynovial …

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Genentech Submits sBLA to FDA for Kadcyla for Adjuvant Treatment in HER2-Positive Early Breast Cancer with Residual Disease After Neoadjuvant Treatment

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced completing the submission of a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA) for Kadcyla® (ado-trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer …

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FDA Grants Orphan Drug Designation to BioLineRx’s Lead Candidate BL-8040 for the Treatment of Pancreatic Cancer

Tel Aviv, Israel, February 4, 2019 – BioLineRx Ltd. (NASDAQ/TASE:BLRX), a clinical-stage biopharmaceutical company focused on oncology, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead oncology candidate, BL-8040, for the treatment of pancreatic cancer.  “Orphan Drug Designation in pancreatic cancer …

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