[ Price : $8.95]
FDA says it is removing a Boxed Warning about amputation risk on Janssens diabetes drug canagliflozins (Invokana, Invokamet, Invok...[ Price : $8.95]
CBER updates its Calendar Year 2020 guidance agenda listing 28 planned guidances in four categories.[ Price : $8.95]
CDER publishes a MAPP describing responsibility in the Office of Generic Drugs for processing drug application ownership changes i...[ Price : $8.95]
FDA posts final determinations for three drugs under the drug efficacy study implementation program.[ Price : $8.95]
FDA publishes a draft guidance on designing clinical trials for cancer drugs in patients with central nervous system metastases.[ Price : $8.95]
FDA accepts for priority review an EMD Serono NDA for once-daily, orally-dosed tepotinib for treating certain adult patients with ...[ Price : $8.95]
Five major stakeholders praise PDUFA performance to date and suggest improvements to be included in the 2022 PDUFA 7 reauthorizati...[ Price : $8.95]
Former FDA commissioner Margaret Hamburg and principal deputy commissioner Joshua Sharfstein say the Trump administration and FDA ...