[ Price : $8.95]
FDA cites Medispray Laboratories, a finished drug product manufacturer based in Ponda, Goa, India, for significant lapses in its q...[ Price : $8.95]
Intellia Therapeutics reports that a patient who experienced liver toxicity after being administered the companys CRISPR-based the...[ Price : $8.95]
FDA approves Janssens Darzalex Faspro (daratumumab and hyaluronidase-fihj) for adults with high-risk smoldering multiple myeloma (...[ Price : $8.95]
Senate Democrats say they are worried that FDA and HHS may rely on partisan junk science during its recently announced review of t...[ Price : $8.95]
FDA publicly releases an 11/4 complete response letter issued to Biohaven on its NDA seeking approval for troriluzole to treat spi...[ Price : $8.95]
FDA extends by three months its review of Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide) and its use in trea...[ Price : $8.95]
FDA releases the form FDA-483 with six observations from an inspection at the Baxter Oncology drug manufacturing facility in Halle...[ Price : $8.95]
FDA publishes 76 new and revised product-specific guidances intended to speed generic drug development and approval.