CDER issues a summary report on the drug snapshots posted in 2018 for 59 novel drugs, showing the role demographic factors played in the safety and ef...
Sen. Bernie Sanders asks Catalyst Pharmaceuticals to explain its decision to set an annual list price of $375,000 for its recently-acquired Firdapse t...
Federal Register notice: FDA issues a guidance entitled Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Ap...
Federal Register notice: FDA determines that Genentechs Esbriet (pirfenidone) film coated tablets (534 mg) was not withdrawn from sale for safety or e...
FDAers Gideon Blumenthal and Richard Pazdur discuss the agencys approval of new cancer treatments in 2018.
Genus Lifesciences says its NCE exclusivity for a cocaine nasal spray precludes any 505(b)(2) applications from other companies, including Lannett, fo...
FDA says Lymol Medical has failed to submit on time the final report for its postmarketing requirement for sterile powder talc.
Federal Register notice: FDA withdraws approval of ANDA #061579 for nonsterile neomycin sulfate powder for prescription compounding due to safety conc...