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Infectious Diseases

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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AbCellera and Gilead Enter Infectious Disease Therapeutic Antibody Discovery Collaboration

VANCOUVER, British Columbia–(BUSINESS WIRE)–AbCellera, a leader in therapeutic antibody discovery from natural immune systems, today announced it has entered into an agreement with Gilead Sciences to support the discovery of therapeutic antibody candidates for infectious diseases. AbCellera will apply its expertise in single-cell screening of natural immune sources to generate …

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FDA Approves Merck’s Zerbaxa 3g Dose for the Treatment of Adults with Hospital-Acquired Pneumonia

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Merck’s supplemental New Drug Application (sNDA) for the use of ZERBAXA® (ceftolozane and tazobactam) for the treatment of patients 18 years and older with hospital-acquired bacterial …

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FDA Grants Breakthrough Therapy Designation to La Jolla Pharmaceutical’s Investigational Treatment for Severe Malaria

SAN DIEGO, April 24, 2019 (GLOBE NEWSWIRE) — La Jolla Pharmaceutical Company (Nasdaq: LJPC), a leader in the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for …

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