U.S. Supreme Court justices appear to be leaning in Mercks favor in its pursuit to reverse a 3rd Circuit Court of Appeals ruling that allowed hundreds...
FDA clears a Neocis 510(k) for additional dental materials to be used with Yomi, the companys robot-assisted dental surgery system.
FDA issues a new Software Precertification (Pre-Cert) Pilot Program working model 1.0, Test plan, and regulatory framework to explain how it envisions...
Lupin Pharmaceuticals recalls 42 lots of ceftriaxone for injection in varying product strengths because they have been found to contain visual grey pa...
CDER says it saw a 28% increase in novel new drug approvals last year jumping from 46 approvals in 2017 to 59 in 2018.
FDA grants Rainier Therapeutics a fast track designation for its targeted antibody vofatamab for treating patients with advanced or metastatic urothel...
FDA Review posts the Federal Register notices published during our annual end-of-year holiday break.
FDA Review posts product approval summaries for the week ending 1/4/2019.