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FDA Approves Merck’s Keytruda for Treatment of Patients with Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma

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 treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC), based on the …

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AstraZeneca’s Lynparza Granted FDA Approval for First-Line Maintenance Therapy in BRCA-Mutated Advanced Ovarian Cancer

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has approved LYNPARZA for use as maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAmor sBRCAm) advanced epithelial …

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FDA Approves Myriad’s BRACAnalysis CDx as Companion Diagnostic for Lynparza in Patients with Advanced-Stage, BRCA-Mutated Ovarian Cancer

SALT LAKE CITY, Dec. 19, 2018 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and personalized medicine, today announced that the U.S. Food and Drug Administration (FDA) has approved BRACAnalysis CDx® to be used by healthcare professionals to identify patients with advanced ovarian cancer who have a germline BRCAmutation …

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FDA Grants Breakthrough Therapy Designation to Eiger’s Lonafarnib for Treatment of Progeria and Progeroid Laminopathies

PALO ALTO, Calif., December 19, 2018 — Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for rare and ultra-rare diseases, today announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lonafarnib for the treatment of Hutchinson-Gilford progeria syndrome (HGPS or Progeria) …

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Flexion Submits sNDA to FDA for Zilretta Aiming to Revise Product Label with New Data Indicating Repeat Administration was Safe and Well Tolerated

BURLINGTON, Mass., Dec. 17, 2018 (GLOBE NEWSWIRE) — Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced it submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) to revise the product label for ZILRETTA (triamcinolone acetonide extended-release injectable suspension). The sNDA is based on data from an …

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Amgen Submits BLA to the FDA for ABP 710, a Biosimilar Candidate to Infliximab

THOUSAND OAKS, Calif., Dec. 17, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to REMICADE® (infliximab). “At Amgen, we have spent nearly four decades developing, manufacturing and producing transformative medicines. We’re leveraging our deep expertise and …

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FDA Grants Breakthrough Therapy Designation to Eiger’s Lonafarnib for Treatment of Hepatitis Delta Virus Infection

PALO ALTO, Calif., Dec. 17, 2018 /PRNewswire/ — Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for rare and ultra-rare diseases, today announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lonafarnib for the treatment of hepatitis delta virus …

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Alkermes and Biogen Announce Submission of a NDA to the FDA for Diroximel Fumarate in Multiple Sclerosis

DUBLIN, Ireland and CAMBRIDGE, Mass., Dec. 17, 2018 (GLOBE NEWSWIRE) — Alkermes plc (Nasdaq: ALKS) and Biogen Inc. (Nasdaq: BIIB) today announced that Alkermes has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for diroximel fumarate (BIIB098), a novel oral fumarate in development for the treatment of relapsing …

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Celltrion and Teva Announce FDA Approval of Herzuma, a Biosimilar to Herceptin, for Treatment of HER2-Overexpressing Breast Cancer

INCHEON, South Korea & JERUSALEM–(BUSINESS WIRE)–Celltrion, Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd.(NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved HERZUMA® (trastuzumab-pkrb), a HER2/neu receptor antagonist biosimilar to HERCEPTIN®1 (trastuzumab) for the following indications: Adjuvant Breast Cancer of HER2 overexpressing node positive or node negative (ER/PR …

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FDA Approves Amgen’s Nplate for Use in Pediatric Patients with Immune Thrombocytopenia

THOUSAND OAKS, Calif., Dec. 14, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Nplate®(romiplostim) for the treatment of pediatric patients one year of age and older with immune thrombocytopenia (ITP) for at least six months who have had an insufficient …

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