Former FDA commissioner Scott Gottlieb says FDA is likely to see up to a 25% reviewer exodus over the coming months as about 600 reviewers have curren...
HHS secretary Robert F. Kennedy Jr. vows to restore FDAs and other health agencies Freedom of Information Act (FOIA) offices that were gutted earlier ...
A Northern Texas federal judge denies a preliminary injunction sought by Outsourcing Facilities Association to delay FDA enforcement actions against c...
FDA grants Orchestra BioMed a breakthrough device designation for its atrioventricular interval modulation therapy that uses a pacemaker to reduce blo...
FDA issues a clinical hold on VYNE Therapeutics Phase 1b study evaluating VYN202 for treating moderate-to-severe plaque psoriasis based on testicular ...
A new biosimilars report says that FDA has approved a total of 73 biosimilars across 19 unique biological molecules, and so far only 48 (66%) of these...
Axios reports that key FDA databases that are relied on by healthcare professionals are not being fully updated due to staff shortages resulting from ...
FDA approves an Akeso Biopharma BLA for penpulimab-kcqx, indicated for adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.
