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Spero Therapeutics Receives QIDP Designation from the FDA for the Development of SPR720 in Non-Tuberculous Mycobacterial and Lung Infections

CAMBRIDGE, Mass., Feb. 26, 2019 (GLOBE NEWSWIRE) — Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant bacterial infections, announced today that SPR720, an orally administered antimicrobial agent being developed for the treatment of non-tuberculous mycobacterial (NTM) infections, has been granted Qualified …

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FDA Approves Taiho Oncology’s Lonsurf for Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

PRINCETON, N.J., February 25, 2019 – Taiho Oncology, Inc. today announced that the United States Food and Drug Administration (FDA) has approved LONSURF® as a treatment for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, …

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Alkermes and Biogen Announce FDA Acceptance of Diroximel Fumarate NDA for Multiple Sclerosis

DUBLIN, Ireland and CAMBRIDGE, Mass., Feb. 25, 2019 (GLOBE NEWSWIRE) — Alkermes plc (Nasdaq: ALKS) and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for diroximel fumarate (BIIB098), a novel oral fumarate in development for the treatment of relapsing forms …

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FDA Grants Breakthrough Therapy Designation to Amicus’ Investigational Pompe Disease Therapy

CRANBURY, N.J., Feb. 25, 2019 (GLOBE NEWSWIRE) — Amicus Therapeutics (Nasdaq: FOLD) today announced that the U.S. Food and Drug Administration (FDA) has granted to Amicus a Breakthrough Therapy Designation (“BTD”) to AT-GAA for the treatment of late onset Pompe disease, an inherited lysosomal storage disorder caused by the deficiency of an enzyme known as …

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FDA Grants Priority Review to Merck’s sBLA for Keytruda Monotherapy for Third-Line Treatment of Patients with Advanced SCLC

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 patients with …

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Xencor Announces Partial Clinical Hold on Phase 1 Study of its Bispecific Antibody in Acute Myeloid Leukemia

MONROVIA, Calif., Feb. 20, 2019 /PRNewswire/ — Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune diseases, asthma and allergic diseases, today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on its Phase 1 study of XmAb14045, a CD123 x …

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FDA Approves Novo Nordisk’s Esperoct for Treatment of Adults and Children with Hemophilia A

Bagsværd, Denmark, 19 February 2019 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application for ESPEROCT® for the treatment of adults and children with hemophilia A. ESPEROCT® is the brand name for turoctocog alfa pegol, N8-GP. ESPEROCT® is indicated for use in adults and …

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FDA Grants Priority Review to AbbVie’s Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis

NORTH CHICAGO, Ill., Feb. 19, 2019 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its New Drug Application (NDA) for upadacitinib for the treatment of adult patients with moderate to severe rheumatoid arthritis. Upadacitinib is …

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Cerecor Receives Fast Track Designation from FDA for CERC-801 for the Treatment of PGM1 Deficiency

ROCKVILLE, Md., Feb. 19, 2019 (GLOBE NEWSWIRE) — Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases in pediatrics and neurology, announced today that the U.S. Food and Drug Administration (FDA) has designated Fast Track Designation …

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FDA Approves Merck’s Keytruda for the Adjuvant Treatment of Melanoma Patients with Lymph Node Involvement Following Complete Resection

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 approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection based on results from …

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