Rubicon Research announced that the United States Food and Drug Administration (USFDA) conducted an unannounced inspection of its manufacturing facility located at Pithampur, Madhya Pradesh.
Three infants in California, Pennsylvania and Washington were hospitalized with botulism after drinking Nara Organics ...
The FDA's New Registration Rule and What It Means for the Cigar World The battle between America's premium cigar industry and ...
Posts claimed federal officials "upgraded" the recall to the highest level, meaning there's a "reasonable probability of ...
After a site visit by FDA inspectors yielded a Form 483 for Genzyme Ireland in early 2026, the Sanofi subsidiary is facing further reprimand from the U.S. regulator.  | After a site visit by FDA ...
The US FDA has declined to approve Unicycive Therapeutics’ resubmitted NDA for OLC to treat hyperphosphatemia in CKD patients on dialysis.
Galderma shares fell after the Swiss skincare specialist failed to obtain approval from the U.S. Food and Drug Administration for its latest product to rival AbbVie's Botox for the second time. Shares ...
Galderma's application for its latest product to rival AbbVie's Botox was declined by the U.S. Food and Drug Administration after a manufacturing-site inspection, three years after a prior submission ...
Glenmark Pharmaceuticals Limited has informed the stock exchanges that the United States Food and Drug Administration (USFDA) has completed a Good Manufacturing Practice (GMP) ...
Glenmark Pharmaceuticals has received a Form 483 with six observations following a US FDA GMP inspection of its Goa ...
The U.S. Food and Drug Administration (FDA) recently announced a pilot program for "One-Day Inspectional Assessments," a new ...