GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...
Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...
Here is a select list of cancer therapies approved by the FDA throughout the month of January, featuring patient populations ...
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...
SANTA ANA, Calif. - NKGen Biotech, Inc. (NASDAQ: NKGN), a clinical-stage biotechnology company with a current market capitalization of $17 million, has received Fast Track designation from the U.S.
The intravenous antibiotic Emblaveo, a combination of aztreonam and avibactam approved in Europe last year, was developed in ...
Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...
Acceptance follows resolution of third-party fill/finish manufacturing issuesFDA decision expected by July 10, 2025 TARRYTOWN, N.Y., Feb. 11, ...
The FDA’s new approval makes the drug the first GLP-1 ... senior vice president of clinical development, medical & regulatory affairs for Novo Nordisk, maker of Ozempic — in a press release.
Vertex Pharmaceuticals ( VRTX 5.31%) just snagged its second U.S. Food and Drug Administration (FDA) approval in only 41 days. On Dec. 20, 2024, the FDA gave a thumbs-up to Alyftrek in treating cystic ...
GNA-The Ghana Food and Drugs Authority (FDA) has spearheaded a joint initiative with National Regulatory Authorities (NRAs) ...