FDA News

Ipsen Announces Updated Indication for Dysport® (abobotulinumtoxinA) for the Treatment of Spasticity in Children

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Ipsen Biopharmaceuticals, an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY), announced today that the United States Food and Drug Administration (FDA) has approved the expanded use of Dysport® (abobotulinumtoxinA) in pediatric patients. When Dysport was first FDA-approved in 2016 for pediatric lower limb spasticity, Ipsen was granted Orphan Drug …

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Mylan and Fujifilm Kyowa Kirin Biologics Announce that the FDA Approved of Hulio, a Biosimilar to Humira

HERTFORDSHIRE, England and PITTSBURGH and TOKYO, July 9, 2020 /PRNewswire/ — Mylan N.V. (NASDAQ: MYL) and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Hulio® (adalimumab-fkjp), a biosimilar to AbbVie’s Humira® (adalimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic …

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FDA Grants Priority Review to Merck’s sBLA for Second-Line Treatment of Relapsed or Refractory Classical Hodgkin Lymphoma

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, as monotherapy for the treatment of adult …

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FDA Grants Fast Track Designation to Assembly Biosciences’ Investigational Treatment for Chronic Hepatitis B Virus Infection

SOUTH SAN FRANCISCO, Calif., July 09, 2020 (GLOBE NEWSWIRE) — Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ABI-H2158 (2158) …

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Biogen Submits BLA to the FDA for Approval of Aducanumab as a Treatment of Alzheimer’s Disease

CAMBRIDGE, Mass. and TOKYO, July 08, 2020 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that Biogen has completed the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of aducanumab, an investigational treatment for …

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FDA Grants Breakthrough Therapy Designation to Concert’s CTP-543 for Treatment of Alopecia Areata

LEXINGTON, Mass.–(BUSINESS WIRE)–Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the Company’s oral Janus kinase inhibitor, CTP-543, for the treatment of adult patients with moderate-to-severe alopecia areata. There are currently no drugs approved by the FDA for the treatment …

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Merck and Eisai Receive CRL from the FDA for Keytruda Plus Lenvima Combination as First-Line Treatment for Unresectable Hepatocellular Carcinoma

KENILWORTH, N.J. & WOODCLIFF LAKE, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Merck’s and Eisai’s applications seeking accelerated approval of KEYTRUDA, Merck’s anti-PD-1 therapy, …

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FDA Approves Inqovi Tablets, Oral Hypomethylating Agent Therapy for Intermediate and High-Risk MDS and CMML

PLEASANTON, Calif. & PRINCETON, N.J. & TOKYO–(BUSINESS WIRE)–Astex Pharmaceuticals, Inc.; Taiho Oncology, Inc.; and Otsuka Pharmaceutical Co., Ltd. today announce that the U.S. Food and Drug Administration (FDA) and Health Canada have approved INQOVI® (decitabine and cedazuridine) tablets. The three companies are all part of the Otsuka group of companies. INQOVI …

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FDA Places Clinical Hold on Cellectis MELANI-01 Study in Multiple Myeloma

NEW YORK, July 06, 2020 (GLOBE NEWSWIRE) — Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), today announced that the MELANI-01 trial has been placed on clinical hold by the U.S. Food and Drug Administration (FDA).   This clinical hold …

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FDA Lifts Partial Clinical Hold on ADC Therapeutics’ Phase 2 Clinical Trial of Camidanlumab Tesirine in Hodgkin Lymphoma

LAUSANNE, Switzerland–(BUSINESS WIRE)–ADC Therapeutics SA (NYSE:ADCT), a clinical-stage oncology-focused biotechnology company leading the development and commercialization of next-generation antibody drug conjugates (ADCs) with highly potent and targeted pyrrolobenzodiazepine (PBD) dimer technology, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the pivotal …

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