FDA News

FDA Approves Opdivo + Yervoy as First-Line Treatment of Patients with Metastatic NSCLC Whose Tumors Express PD-L1≥1%

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by …

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FDA Approves Bristol Myers Squibb’s Pomalyst for AIDS-Related and HIV-Negative Kaposi Sarcoma

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that Pomalyst® (pomalidomide) was approved by the U.S. Food and Drug Administration (FDA) for patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy (HAART), or in patients with Kaposi sarcoma who are HIV-negative.3 Patients with AIDS-related Kaposi sarcoma should …

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Blueprint Medicines Receives CRL from FDA for Avapritinib NDA for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor

CAMBRIDGE, Mass., May 15, 2020 /PRNewswire/ — Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the new drug application of avapritinib …

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Seelos Therapeutics Receives Rare Pediatric Disease Designation for SLS-005 for Treatment of Sanfilippo Syndrome

NEW YORK, May 15, 2020 (GLOBE NEWSWIRE) — Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced it has been granted Rare Pediatric Disease Designation (RPDD) for SLS-005 in Sanfilippo syndrome from the U.S. …

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FDA Informs Public About Possible Accuracy Concerns with Abbott ID NOW Point-of-Care Test to Diagnose COVID-19

Today, the U.S. Food and Drug Administration is alerting the public to early data that suggest potential inaccurate results from using the Abbott ID NOW point-of-care test to diagnose COVID-19. Specifically, the test may return false negative results. “We are still evaluating the information about inaccurate results and are in …

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Bristol Myers Squibb and bluebird bio Provide FDA Update on Idecabtagene Vicleucel for the Treatment of Multiple Myeloma

PRINCETON, N.J., & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced that the companies received a Refusal to File letter from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121) for patients with heavily pre-treated relapsed …

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Abbott Receives FDA Emergency Use Authorization for COVID-19 Molecular Test on New Alinity m System

ABBOTT PARK, Ill., May 12, 2020 /PRNewswire/ — Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the company’s molecular test for the novel coronavirus (COVID-19) for use on its new Alinity™ m molecular laboratory instrument. Abbott is in …

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Moderna Receives FDA Fast Track Designation for its mRNA Vaccine Against Novel Coronavirus

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s mRNA vaccine candidate (mRNA-1273) …

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FDA Grants Breakthrough Therapy Designation to Enhertu for HER2-Positive Metastatic Gastric Cancer

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Daiichi Sankyo Company, Limited’s (Daiichi Sankyo) ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab. Gastric cancer …

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FDA Approves Lynparza as First-Line Maintenance Treatment with Bevacizumab for HRD-Positive Advanced Ovarian Cancer

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that Lynparza (olaparib) in combination with bevacizumab has been approved in the US for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who …

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