[ 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FDA publishes a draft guidance on designing clinical trials for cancer drugs in patients with central nervous system metastases.[ Price : $8.95]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 ...[ Price : $8.95]
Ipsen says it is planning to submit an NDA for palovarotene and its use in treating patients with fibrodysplasia ossificans progre...[ Price : $8.95]
FDA says it will temporarily allow the distribution of some rifampin and rifapentine with nitrosamine impurities to avoid shortage...[ Price : $8.95]
FDA commissioner Stephen Hahns controversial remarks exaggerating the efficacy of convalescent plasma touches off a wider examinat...