GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...
The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of non-cancerous tumors on ...
Biohaven's NDA for Troriluzole was accepted by the FDA, potentially leading to approval in Q3 2025. Click here to find out ...
The Food and Drug Administration approved mirdametinib, brand name Gomekli, from SpringWorks Therapeutics (SWTX), a kinase inhibitor, for adult ...
The U.S. Food and Drug Administration said on Tuesday it has approved SpringWorks Therapeutics' drug to treat a type of rare ...
Hims & Hers is under scrutiny for promoting compounded weight-loss drugs in a Super Bowl ad without clear FDA approval or side effect disclosures. These compounded drugs, unlike generics, are not ...
A large number of Australian biotechs are waiting for US FDA product approval – or are on the cusp of ... Read More The post ...
Twenty years ago, in 2004, Congress passed the Project BioShield Act, which established the Biomedical Advanced Research and ...
The FDA has made some modest efforts, but it needs an internal organization that understands and would be an aggressive ...
The next FDA Commissioner could solve two big problems with one powerful policy: encourage independent testing of both ...
GNA-The Ghana Food and Drugs Authority (FDA) has spearheaded a joint initiative with National Regulatory Authorities (NRAs) ...
The telehealth company Hims & Hers put out a Super Bowl ad that skimped on clarifying that its compounded semaglutide medications aren't FDA-approved.