FDA grants Orchestra BioMed a breakthrough device designation for its atrioventricular interval modulation therapy that uses a pacemaker to reduce blo...
A Northern Texas federal judge denies a preliminary injunction sought by Outsourcing Facilities Association to delay FDA enforcement actions against c...
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...
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.
FDA awards BrainChild Bio a breakthrough therapy designation for its investigational CAR T-cell therapy, BCB-276, for treating a rare and fatal pediat...
Amneal Pharmaceutical recalls two lots of ropivacaine hydrochloride injection USP, 500 mg/100 mL, infusion bags because the products may contain an in...
