More than 30 babies in 15 states have been sickened in a growing outbreak of infant botulism linked to recalled ByHeart ...
The FDA said it received multiple reports that the baby formula is still being found on store shelves in multiple states.
The agency considered clinical trial data showing Redemplo can significantly reduce triglyceride levels in patients with familial chylomicronemia syndrome versus placebo.
Pharmaceutical Technology on MSNOpinion
FDA inspection reveals critical supply chain vulnerabilities
Amanda Murphy, Senior Director at GlobalData, discusses how real-time intelligence can turns regulatory events into ...
One of the most highly regulated sectors in the U.S. food industry is still too vulnerable to contamination.
Clinical trials are more connected and more closely examined than ever. Inspection readiness isn’t a last-minute document ...
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and ...
A U.S. representative is pressing the FDA for information about ByHeart Inc., the company linked to an outbreak of infant ...
A Pennsylvania plant run by the company, ByHeart, was shut down this year after inspectors found mold, a leaking roof and ...
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