FDA News

FDA Approves Lilly’s Retevmo for Patients with Advanced RET-Driven Lung and Thyroid Cancers

INDIANAPOLIS, May 8, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) approved Retevmo™ (selpercatinib, 40 mg & 80 mg capsules), the first therapy specifically indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), and the treatment of …

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FDA Grants Fast Track Designation For Omecamtiv Mecarbil In Heart Failure

THOUSAND OAKS, Calif., and SOUTH SAN FRANCISCO, Calif., May 08, 2020 (GLOBE NEWSWIRE) — Amgen (NASDAQ:AMGN) and Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for omecamtiv mecarbil, a novel selective cardiac myosin activator, also known as a cardiac myotrope,1 being …

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Novartis Announces FDA Approval of MET Inhibitor Tabrecta for Metastatic Non-Small Cell Lung Cancer with METex14

Basel, May 6, 2020 — Novartis announced today that the US Food and Drug Administration (FDA) approved Tabrecta™ (capmatinib, formerly INC280), an oral MET inhibitor for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by an …

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FDA Approves FoundationOne®CDx as the Companion Diagnostic for Tabrecta, a MET Inhibitor for Patients with Metastatic NSCLC with METex14

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc. today announced that FoundationOne®CDx has been approved by the U.S. Food and Drug Administration (FDA) for use as the companion diagnostic (CDx) to aid in identifying patients with non-small cell lung cancer (NSCLC) for whom treatment with Tabrecta™ (capmatinib) may be appropriate. Tabrecta is the …

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Cabaletta Bio Receives FDA Fast Track Designation for DSG3-CAART for Treatment of Mucosal Pemphigus Vulgaris

PHILADELPHIA–(BUSINESS WIRE)–Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for DSG3-CAART (Desmoglein 3 Chimeric AutoAntibody Receptor …

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AstraZeneca’s Farxiga Receives FDA Approval for Treatment of Heart Failure in Patients with Reduced Ejection Fraction

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca’s FARXIGA® (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type 2 diabetes (T2D). The approval by the Food and Drug …

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FDA Extends Action Date for Bristol-Myers Squibb’s BLA for Lisocabtagene Maraleucel for Treatment of Large B-Cell Lymphoma

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has extended the action date by three months for the biologics license application (BLA) for lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adults with relapsed …

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FDA Grants Medivir’s MIV-818 Orphan Drug Designation for Treatment of Hepatocellular Carcinoma

STOCKHOLM, May 6, 2020 /PRNewswire/ — Medivir AB (Nasdaq Stockholm: MVIR) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to MIV-818 for the treatment of patients with hepatocellular carcinoma (HCC), the most common type of primary liver cancer. FDA grants orphan status …

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FDA Approves Darzalex Faspro, a New Subcutaneous Formulation of Daratumumab in the Treatment of Patients with Multiple Myeloma

HORSHAM, Pa., May 1, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj), a new subcutaneous formulation of daratumumab. DARZALEX FASPRO™ is approved in four regimens across five indications in multiple myeloma patients, including newly diagnosed, transplant-ineligible patients …

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FDA Approves Tolmar’s Fensolvi for Treatment of Pediatric Patients with Central Precocious Puberty

BUFFALO GROVE, Ill., May 4, 2020 /PRNewswire/ — Tolmar Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application for FENSOLVI® (leuprolide acetate) for injectable suspension for the treatment of pediatric patients two years of age and older with central precocious puberty …

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