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FDA grants Karyopharm Therapeutics a fast track designation for selinexor, the companys first-in-class, oral Sine compound for tre...[ Price : $8.95]
Five major drug companies suggest changes to an FDA draft guidance on using placebo controls in cancer clinical trials.[ Price : $8.95]
FDA releases the FDA-483 with seven observations following an inspection at MedisourceRx.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Hypertension: Developing Fixed- Combination Drug Products f...[ Price : $8.95]
FDA clears an MRI Interventions 510(k) for its latest software platform, ClearPoint 2.0.[ Price : $8.95]
Attorney Scott Lassman says protein drug sponsors may sue FDA over a 2016 draft guidance on requiring BLAs for such products as of...[ Price : $8.95]
FDA releases the latest FDA-483 detailing problems at another Akorn manufacturing facility, this time in Somerset, NJ.