FDA commissioner Robert Califf says that approval of stem-cell therapies should be based on scientific evidence.
Egalet Corp. files a supplemental NDA for Oxaydo (oxycodone HCl) tablets for an abuse-deterrent label claim for the intravenous route of abuse.
CDER issues its latest drug standards program quarterly progress report.
FDA denies two petitions asking it to find that Wyeths original formulation of Protonix IV was not withdrawn for reasons of safety.
Pfizer says its pivotal REFLECTIONS B3271002 study, a comparative safety and efficacy study of biosimilar candidate PF-05280014 versus Genentechs Herc...
FDA sets a user fee review goal date of 7/7/2017 for an Emmaus Life Sciences NDA for its orally administered pharmaceutical grade L-glutamine treatmen...
FDA deputy commissioner Howard Sklamberg outlines a new final rule with data submission requirements for importers of FDA-regulated products using the...
FDA cites Prescription Lab Compounding Pharmacy and Stonegate Pharmacy in two recent Warning Letters as part of FDAs increased scrutiny of drug compou...