Jiangsu Hengrui Pharmaceuticals and its partner Elevar Therapeutics will have to wait even longer before their PD-1 inhibitor ...

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 ...

Test results from Consumer Reports found potentially harmful chemicals in roughly half of the formula products. “Eight of the ...

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 ...

We analysed new anticancer drug indications approved by the FDA and EMA between 2020 and 2023 using the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale quality-of-life ...

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 ...

Commits to ‘independent scientific review’ of key abortion drug If confirmed, Makary stands to have enormous influence over access to drugs in the U.S. including the mifepristone, one of two drugs ...

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 ...