Alachua, Florida biologics contract development and manufacturing organization (CDMO), Ology Bioservices, Inc., announced this week that it was awarded an Other Transaction Agreement (OTA) to support the...

The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that...

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Product Quest Manufacturing  is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. The product was found to have had microbiological...

The Food and Drug Administration (FDA) issued a warning Friday concerning the long-term use of azithromycin (Zithromax, Zmax) for prophylaxis of bronchiolitis obliterans syndrome to patients who undergo...

GlaxoSmithKline (GSK) and Medicines for Malaria Venture (MMV) announced that the United States Food and Drug Administration (FDA) has approved, under Priority Review, single-dose Krintafel (tafenoquine)...

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) has approved SYMTUZA™, the first and only complete, darunavir-based single-tablet regimen...

SIGA Technologies, Inc. (SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced that the U.S. Food and Drug Administration (FDA) has approved oral TPOXX® (tecovirimat)...

The U.S. Food and Drug Administration today is requiring safety labeling changes for a class of antibiotics called fluoroquinolones to strengthen the warnings about the risks of mental health side effects...

Analysis of outpatient records of large number of British patients reveals that those believed to be allergic to penicillin have significantly increased risks of contracting the dangerous infections MRSA (methicillin-resistant...