A US Food and Drug Administration (FDA) official acknowledged significant regulatory hurdles in the development of products ...
If the FDA approves a drug for a neglected tropical disease, the company gets a voucher that accelerates review of another drug. This remains controversial.
Please provide your email address to receive an email when new articles are posted on . One presentation at this year’s vMed conference highlighted updated federal policies in the digital health space ...
WASHINGTON, DC / ACCESS Newswire / March 26, 2026 / The Centers for Medicare & Medicaid Services (CMS) is preparing to launch an unprecedented federal pilot program that could furnish participating ...
Generic combination drug product applications (Abbreviated New Drug Applications-ANDA) are rapidly increasing, driven by the rise of GLP-1 drugs. In this one-hour webcast, you'll receive detailed ...
Despite many efforts over the years, drug developers have not yet secured an FDA approval for a disease-modifying osteoarthritis drug (DMOAD). Biosplice Therapeutics aims to change that with its ...
FDA moves shaping drug development and oversight include new gene therapy guidance, clinical trial transparency efforts, and recent drug approvals.
A CNBC investigation revealed the proliferation of AFPs, which import prescription drugs from overseas in what U.S.
Washington — Federal health officials posted a warning Tuesday about misleading statements made by biotech billionaire Dr. Patrick Soon-Shiong, who recently told podcast listeners his company's ...
By Sneha S K April 16 (Reuters) - The U.S. Food and Drug Administration should be more transparent when granting accelerated ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results