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Antibiotics: FDA Accepts For Review Supplemental New Drug Application for RECARBRIO™

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Merck today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for RECARBRIO™ (imipenem, cilastatin, and relebactam) to treat...

Peanut allergies: FDA approves Palforzia for children

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By NewsDesk  @infectiousdiseasenews On Friday, the U.S. Food and Drug Administration approved Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] to mitigate allergic reactions, including anaphylaxis,...

Novel coronavirus medical countermeasures: FDA announces key actions to advance development

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The U.S. Food and Drug Administration (FDA) announced today critical actions to advance development of novel coronavirus medical countermeasures. As with any emerging public health threat, the FDA will...

Clostridioides difficile antibiotic, DIFICID, receives FDA approval for treating children aged six months and older

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Merck announced today the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for DIFICID® (fidaxomicin) for oral suspension, and a supplemental New Drug Application (sNDA)...

Antibiotic challenges and the Melinta situation

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By NewsDesk  @infectiousdiseasenews In late December 2019, antibiotic development and commercialization company, Melinta Therapeutics, Inc. initiated a voluntary Chapter 11 process to effectuate restructuring...

migraine

Migraine treatment, Ubrelvy, receives FDA approval

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The U.S. Food and Drug Administration today approved Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults....

Eliquis generics receive FDA approval

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The U.S. Food and Drug Administration has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular...

Breast cancer: FDA approves new treatment, Enhertu, for patients with HER2-positive breast cancer

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The U.S. Food and Drug Administration granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic...

Anthrax antibiotic: Project BioShield funding targets health security threat

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This week, the U.S. Department of Health and Human Services (HHS) issued the first Project BioShield contract to fund the advanced development needed to support the expanded use of an existing antibiotic...

Staphylococcus aureus: The Bengal Bay clone mutations and global spread

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Staphylococcus aureus is a major human pathogen prone to developing antibiotic resistance, causing 120,000 cases of bloodstream infections every year in the United States and over 5000 in Australia; the...