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...

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,...

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...

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)...

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

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....

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...

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...

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 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...