FDA News

FDA Approves ViiV Healthcare’s Rukobia, a First-in-Class Treatment for HIV in Adults with Few Treatment Options

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg extended-release tablets. Rukobia is a novel attachment inhibitor for the treatment of HIV-1 infection …

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CENTOGENE Receives FDA Emergency Use Authorization for COVID-19 Molecular Diagnostic Test

CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, July 02, 2020 (GLOBE NEWSWIRE) — Centogene N.V. (Nasdaq: CNTG), a commercial-stage company focused on rare diseases that transforms real-world clinical and genetic data into actionable information for patients, physicians, and pharmaceutical companies, today announced that the U.S. Food and Drug Administration (FDA) …

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FDA Grants Fast Track Designation to MetVital’s Anhydrous Enol-Oxaloacetate for Glioblastoma Multiforme

SAN DIEGO, July 1, 2020 /PRNewswire/ — MetVital, Inc., a privately held biopharmaceutical company developing small molecule modulators of altered glutamate metabolism for the treatment of diseases with significant unmet medical need and commercial potential, today announces that the U.S. Food and Drug Administration (FDA) has notified MetVital that its …

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FDA Approves Bavencio as First-Line Maintenance Treatment for Locally Advanced or Metastatic Urothelial Carcinoma

Rockland, MA and New York, US, JUNE 30, 2020 – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BAVENCIO® …

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FDA Approves Merck’s Keytruda for First-Line Treatment of Patients with Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer

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, as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) …

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FDA Approves Genentech’s Phesgo for Treatment of Patients with HER2-Positive Breast Cancer

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Phesgo™, a fixed-dose combination (FDC) of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC, under the skin) injection in …

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Heron Therapeutics Receives Complete Response Letter from the FDA for HTX-011 for the Management of Postoperative Pain

SAN DIEGO, June 29, 2020 /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 it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on June …

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FDA Approves Chiasma’s Mycapssa Capsules for Long-Term Maintenance Treatment in Patients with Acromegaly

NEEDHAM, Mass., June 26, 2020 (GLOBE NEWSWIRE) — Chiasma, Inc. (NASDAQ: CHMA), a commercial stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) approved MYCAPSSA®(octreotide) capsules for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA is …

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FDA Issues a Complete Response Letter to the BLA for Abicipar Pegol for Treatment of Wet Age-Related Macular Degeneration

NORTH CHICAGO, Ill., June 26, 2020 /PRNewswire/ — Allergan, an AbbVie Company (NYSE: ABBV), and Molecular Partners (SIX: MOLN), a clinical-stage biotechnology company developing a new class of custom-built protein therapeutics known as DARPin® therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response …

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FDA Approves Zogenix’s Fintepla for Treatment of Seizures Associated with Dravet Syndrome

EMERYVILLE, Calif., June 25, 2020 (GLOBE NEWSWIRE) — Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved FINTEPLA® (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older. FINTEPLA will be …

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