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Infectious Diseases

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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Nabriva’s Xenleta Receives FDA Approval for Treatment of Community-Acquired Bacterial Pneumonia

DUBLIN, Ireland, Aug. 19, 2019 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that the U.S. Food and Drug Administration (FDA) has approved Nabriva’s new drug applications for the oral and …

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FDA Approves Breakthrough Drug to Treat Extensively Drug-Resistant Tuberculosis

RESEARCH TRIANGLE PARK, N.C., Aug. 14, 2019 /PRNewswire/ — Today, the Food and Drug Administration (FDA) announced its approval of pretomanid, a new drug developed to treat Extensively Drug-Resistant Tuberculosis (XDR-TB) and treatment intolerant/non-responsive Multidrug-Resistant (MDR) TB. RTI International (RTI) scientist Dr. Doris Rouse and her team have collaborated closely …

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FDA Grants Qualified Infectious Disease Product Designation to Daré Bioscience’s DARE-BV1 for Treatment of BV in Women

SAN DIEGO, Aug. 12, 2019 (GLOBE NEWSWIRE) — Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, today announced that DARE-BV1, a novel thermosetting hydrogel containing clindamycin phosphate 2%, has been granted Qualified Infectious Disease Product (QIDP) designation by the U.S. Food and Drug Administration (FDA) for the treatment …

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Roche Expands Global Access Program Beyond HIV to Include Diagnostic Tests for Tuberculosis, Hepatitis and HPV

Basel, 22 July 2019 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the Global Access Program is expanding beyond HIV, to include Mycobacterium tuberculosis (MTB), Hepatitis B and C (HBV and HCV), and Human Papillomavirus (HPV) for low and middle income country programs where the disease burden is the …

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