In an effort to guarantee "the ongoing quality, safety, nutritional adequacy, and resilience of the domestic infant formula ...

Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G) Fabhalta is the only oral alternative complement pathway ...

HHS Secretary Robert F. Kennedy Jr. discussed a new initiative aimed at improving the safety and nutritional value of baby ...

Q4 2024 Management View CEO Linda Marban highlighted the acceptance by the FDA of Capricor's Biologics License Application (BLA) for deramiocel, targeting treatment of Duchenne muscular dystrophy (DMD ...

New Drug Application (NDA) for LNZ100 for treatment of presbyopia on track for PDUFA target action date of August 8, 2025Upon FDA approval, ...

Gilead Sciences announced a significant milestone: the U.S. FDA accepted their New Drug Applications (NDAs) for lenacapavir ...

Earlier this year, the United States Department of Health and Human Services Office of the Inspector General (HHS OIG) conducted a review of the Food and Drug Administration (FDA) accelerated approval ...

The FDA has accepted the resubmission of a BLA for odronextamab for the treatment of patients with relapsed/refractory ...

While Congress is renewing the priority review voucher program for rare pediatric diseases, the FDA should be required to keep public records of the passes changing hands, too. For a week I buried ...

Makary said he had nothing to do with canceling the meeting, because he didn't yet work at the FDA. "You have my commitment to review what the committees are doing, how they're being used," he ...

In 2024, the Food and Drug Administration (FDA) significantly invested in reorganizing its internal infrastructure and enhancing operations. These efforts aimed to address the complexities of a ...