Infectious Diseases

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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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 Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization for the First 2019 Novel Coronavirus Diagnostic

Today, the U.S Food and Drug Administration issued an emergency use authorization (EUA) to enable emergency use of the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, this test has been limited to use at CDC laboratories; today’s authorization allows the use of the test at …

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FDA Approves sNDA for Astellas’ Mycamine for the Treatment of Invasive Candidiasis in Pediatric Patients Younger than 4 Months

NORTHBROOK, Ill., Jan. 8, 2020 /PRNewswire/ — Astellas Pharma Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for MYCAMINE® (micafungin for injection) in support of the treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in …

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Allergan Receives FDA Qualified Infectious Disease Product Designation and Fast Track Designation for ATM-AVI for Antibiotic-Resistant Gram-Negative Infections

DUBLIN, Nov. 11, 2019 /PRNewswire/ — Allergan plc (NYSE: AGN) today announced the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) Designation and Fast Track Designation for ATM-AVI (aztreonam and avibactam), for the treatment of complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI), and …

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FDA Grants Breakthrough Therapy Designation for F2G’s Antifungal Agent Olorofim

MANCHESTER, England and VIENNA, Nov. 11, 2019 /PRNewswire/ — F2G Ltd, a UK- and Austria-based biotech company developing novel therapies for life-threatening systemic fungal infections, announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its lead first-in-class candidate, olorofim (formerly F901318) for the …

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Philips and the US Department of Defense Develop Technology Using AI to Identify Infection Before Observable Symptoms

ANDOVER, Mass. & WASHINGTON–(BUSINESS WIRE)–Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, the Defense Threat Reduction Agency (DTRA), and Defense Innovation Unit (DIU) of the U.S. Department of Defense (DoD) today announced highlights from an 18-month project in predictive health monitoring aimed at developing an early warning …

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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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FDA Approves Roche’s cobas Babesia, a Whole Blood Test for Donor Screening

Basel, 20 September 2019 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the cobas Babesia test for use on the cobas 6800/8800 Systems for individual blood donation testing. This is Roche’s first commercially available whole …

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FDA Grants Breakthrough Therapy Designation to Eiger’s Treatment for Hepatitis Delta Virus Infection

PALO ALTO, Calif., Aug. 20, 2019 /PRNewswire/ — Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for rare and ultra-rare diseases, today announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for peginterferon lambda (Lambda) for the treatment of hepatitis …

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