FDA News

FDA Issues Emergency Use Authorization to Thermo Fisher for its TaqPath COVID-19 Combo Kit

Today, the U.S. Food and Drug Administration took another significant diagnostic action during the coronavirus outbreak (COVID-19). The FDA issued the fourth COVID-19 diagnostic Emergency Use Authorization (EUA) to Thermo Fisher for its TaqPath COVID-19 Combo Kit. “This action today shows our agency’s dedication to working around the clock to …

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FDA Grants Fast Track Designation to Empagliflozin for the Treatment of Chronic Kidney Disease

INGELHEIM, Germany, and INDIANAPOLIS, Ind.–(BUSINESS WIRE)–The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of empagliflozin to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced. The …

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FDA Grants Fast Track Designation to Balstilimab and Zalifrelimab for Treatment of Advanced Cervical Cancer

LEXINGTON, Mass., March 12, 2020 /PRNewswire/ — Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Agenus Fast Track designation for investigation of balstilimab [PD-1] in combination …

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FDA Grants Accelerated Approval for Opdivo Plus Yervoy for Patients with Hepatocellular Carcinoma Previously Treated with Sorafenib

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb Company (NYSE: BMY) today announced that Opdivo (nivolumab) 1 mg/kg plus Yervoy (ipilimumab) 3 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) to treat hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib.1,2 Approval for this indication has been granted under …

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Roche Receives FDA Approval for CINtec PLUS Cytology Test to Aid Clinicians in Improving Cervical Cancer Prevention

Basel, 11 March 2020 — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food and Drug Administration (FDA) approval of CINtec® PLUS Cytology as the first biomarker-based triage test for women whose primary cervical cancer screening results are positive for the human papillomavirus (HPV) using the cobas® 4800 HPV Test. This …

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Janssen Announces FDA Breakthrough Therapy Designation for JNJ-6372 for Treatment of Non-Small Cell Lung Cancer

RARITAN, N.J., March 10, 2020 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for JNJ-61186372 (JNJ-6372) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor …

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Daré Bioscience Receives FDA Fast Track Designation for DARE-BV1 for the Treatment of Bacterial Vaginosis

SAN DIEGO, March 10, 2020 (GLOBE NEWSWIRE) — Daré Bioscience, Inc.(NASDAQ: DARE), a leader in women’s health innovation, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for DARE-BV1 for the treatment of bacterial vaginosis (BV) in women. DARE-BV1 was previously granted Qualified Infectious Disease Product …

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FDA Approves Boehringer Ingelheim’s Ofev as First Treatment for Chronic Fibrosing ILDs with a Progressive Phenotype

RIDGEFIELD, Conn., March 9, 2020 /PRNewswire/ — Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved Ofev® (nintedanib) as the first treatment for people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Unclassifiable ILDs, autoimmune ILDs, chronic hypersensitivity pneumonitis, sarcoidosis, myositis, sjogren’s syndrome, …

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FDA Accepts for Review Mylan and Biocon’s BLA for Proposed Biosimilar Bevacizumab

HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, March 9, 2020 /PRNewswire/ — Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan’s Biologics License Application (BLA) for MYL-1402O, a proposed biosimilar to Avastin® (bevacizumab), for review under the 351(k) pathway. The BLA seeks approval …

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AVROBIO Receives Orphan Drug Designation from the FDA for AVR-RD-04 for Treatment of Cystinosis

CAMBRIDGE, Mass.–(BUSINESS WIRE)–AVROBIO, Inc. (Nasdaq: AVRO), a leading clinical-stage gene therapy company with a mission to free people from a lifetime of genetic disease, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company’s investigational gene therapy, AVR-RD-04, for the treatment of …

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