FDA halts release of new drug rejection letters while working to formalize policy
From the article
You might also wanna read
FDA Issues Refusal-to-File Letter to Moderna for mRNA Influenza Vaccine
The article criticizes the FDA's recent actions under the new administration, particularly focusing on a Refusal-to-File (RTF) letter issued
Researchers Call for FDA to Require Negative Drug Studies on Product Labels After Approval of Drug with Mostly Negative Results
Researchers argue that the FDA should require negative studies of new drugs to be included in product labeling, not just positive ones, to p
How excessive FDA manufacturing requirements are bottlenecking cell and gene therapy companies
The article argues that excessive FDA manufacturing requirements are crippling cell and gene therapy companies, using Grace Therapeutics as
Pharma CEOs' silence enables Trump administration's assault on U.S. biomedical research, argues Washington editor
The article argues that pharma CEOs are complicit in the destruction of U.S. science by remaining silent as the Trump administration, partic

Replimune to resubmit melanoma drug for FDA approval after agency leadership changes
Replimune plans to resubmit its melanoma drug for FDA approval following a leadership shakeup at the agency. The drug was twice rejected und

FDA Announces Plans to Restrict Non-Approved GLP-1 Drugs in Compounded Medications
The FDA is announcing its intent to take action against non-FDA-approved GLP-1 drugs, specifically targeting GLP-1 active pharmaceutical ing

Comments
Sign in to join the conversation.
No comments yet. Be the first.