FDA News

FDA Approves Kyprolis in Combination with Darzalex and Dexamethasone for Patients with Relapsed/Refractory Multiple Myeloma

THOUSAND OAKS, Calif., Aug. 20, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the U.S. Food and Drug Administration (FDA) has approved the expansion of the KYPROLIS® (carfilzomib) U.S. prescribing information to include its use in combination with DARZALEX® (daratumumab) plus dexamethasone (DKd) in two dosing regimens — once weekly and twice weekly — for the treatment of patients with relapsed …

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FDA Approves Novartis’ Kesimpta, the First and Only Self-Administered, Targeted B-Cell Therapy for Patients with Relapsing Multiple Sclerosis

Basel, August 20, 2020 — Novartis today announced that the US Food and Drug Administration (FDA) has approved Kesimpta® (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. …

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FDA Grants Fast Track Designation to Kazia’s Paxalisib for Treatment of Glioblastoma

SYDNEY, Aug. 20, 2020 /PRNewswire/ — Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to announce that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Kazia’s paxalisib (formerly GDC-0084) for the treatment of glioblastoma, the most common and …

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Polaryx Therapeutics Receives FDA Fast Track Designation for PLX-200 for the Treatment of Patients with Juvenile Neuronal Ceroid Lipofuscinosis

PARAMUS, N.J., Aug. 20, 2020 /PRNewswire/ — Polaryx Therapeutics Inc., a biotech company developing small molecule therapeutics for lysosomal storage disorders, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to PLX-200 for the treatment of Juvenile Neuronal Ceroid Lipofuscinosis (JNCL/CLN3) patients. JNCL/CLN3 is …

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FDA Rejects Biomarin’s Application for its Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A

SAN RAFAEL, Calif., Aug. 19, 2020 /PRNewswire/ — BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to the Company’s Biologics License Application (BLA) for valoctocogene roxaparvovec gene therapy for severe hemophilia A on August 18, 2020.  The FDA issues a …

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Precision BioSciences Receives Fast Track Disease Designation from FDA for PBCAR0191 Investigational Allogeneic CAR T Cell Therapy

DURHAM, N.C., Aug. 19, 2020 (GLOBE NEWSWIRE) — Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company dedicated to improving life with its novel and proprietary ARCUS® genome editing platform, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Precision for PBCAR0191, the company’s …

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FDA Rejects Gilead’s Filgotinib for Treatment of Rheumatoid Arthritis Over Safety Concerns

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for filgotinib, an investigational treatment for moderately to severely active rheumatoid arthritis (RA). The FDA has requested data from …

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Mustang Bio’s MB-107 Granted Rare Pediatric Disease Designation from the FDA for Treatment of X-linked Severe Combined Immunodeficiency

WORCESTER, Mass., Aug. 17, 2020 (GLOBE NEWSWIRE) — Mustang Bio, Inc. (“Mustang”) (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, today announced that the U.S. Food and Drug Administration …

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FDA Accepts and Grants Priority Review to G1 Therapeutics’ NDA for Trilaciclib for Patients with Small Cell Lung Cancer

RESEARCH TRIANGLE PARK, N.C., Aug. 17, 2020 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for trilaciclib for small cell lung cancer (SCLC) patients being treated with chemotherapy and …

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FDA Issues Emergency Use Authorization to Yale School of Public Health for its SalivaDirect COVID-19 Diagnostic Test

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection. “The SalivaDirect test for rapid detection of SARS-CoV-2 is yet another …

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