FDA News

Janssen Seeks FDA Approval of Stelara for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis

SPRING HOUSE, Pa., Oct. 7, 2019  — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric (ages 6-11) patients with moderate to severe plaque psoriasis …

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FDA Grants Fast Track Designation to Mereo’s Navicixizumab for the Treatment of Heavily Pretreated Ovarian Cancer

LONDON and REDWOOD CITY, Calif., Oct. 07, 2019 (GLOBE NEWSWIRE) — Mereo BioPharma Group plc (NASDAQ: MREO, AIM: MPH), “Mereo” or the “Company” or the “Group,” a clinical stage biopharmaceutical company focused on rare diseases, today announces that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation …

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FDA Approves Gilead’s Descovy for HIV Pre-Exposure Prophylaxis

FOSTER CITY, Calif.–(BUSINESS WIRE)–Oct. 3, 2019– Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved a pre-exposure prophylaxis (PrEP) indication for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF). Descovy for PrEP™ is indicated to reduce the risk of sexually acquired HIV-1 infection in …

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GSK Submits sNDA to the FDA for Trelegy Ellipta for Use in Patients With Asthma

LONDON–(BUSINESS WIRE)–GlaxoSmithKline plc (GSK) and Innoviva, Inc. (INVA) today announced the filing of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) seeking an additional indication for the use of once-daily, single-inhaler triple therapy, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI), for the treatment of asthma …

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Savara Announces FDA Response From Type C Meeting on Molgradex for aPAP Development Program

AUSTIN, Texas–(BUSINESS WIRE)–Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, today announced the response from a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the Molgradex development program for autoimmune pulmonary alveolar proteinosis (aPAP). Molgradex is an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). …

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FDA Accepts Two Applications for Merck’s Dificid for Children Aged Six Months Up to 18 years with Clostridium difficile Infections

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for DIFICID® (fidaxomicin) for oral suspension, and a supplemental NDA (sNDA) for a new indication for use of DIFICID tablets …

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Cepheid Receives FDA Clearance for Xpert BCR-ABL Ultra Test for Monitoring Disease Burden in CML Patients

SUNNYVALE, Calif., Oct. 2, 2019 /PRNewswire/ — Cepheid today announced that it has received clearance from the U.S. Food and Drug Administration for Xpert BCR-ABL Ultra for monitoring disease burden in patients with Chronic Myeloid Leukemia (CML). Xpert BCR-ABL Ultra, an in vitro diagnostic test, is the first FDA-cleared test …

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Geron Announces FDA Fast Track Designation Granted to Imetelstat for Relapsed/Refractory Myelofibrosis

MENLO PARK, Calif., Sept. 30, 2019 (GLOBE NEWSWIRE) — Geron Corporation (Nasdaq: GERN) today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to imetelstat for the treatment of adult patients with Intermediate-2 or High-risk myelofibrosis (MF) whose disease has relapsed after or is …

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FDA Approves Invokana to Treat Diabetic Kidney Disease (DKD) and Reduce the Risk of Hospitalization for Heart Failure in T2D and DKD

RARITAN, N.J., Sept. 30, 2019 — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved a new indication for INVOKANA® (canagliflozin) to reduce the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular (CV) death, and hospitalization for heart failure in …

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Ultragenyx and Kyowa Kirin Announce FDA Approves Label Update for Crysvita for the Treatment of X-Linked Hypophosphatemia

NOVATO, Calif., and TOKYO, Sept. 30, 2019 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare diseases, and Kyowa Kirin Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved a label …

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