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Federal Register notice: FDA submits to OMB an information collection extension for General Licensing Provisions; Section 351(k) B...[ Price : $8.95]
FDA issues Aquestive Therapeutics a complete response letter on its NDA tadalafil oral film, a PDE5 inhibitor currently marketed (...[ Price : $8.95]
FDA seeks input on how it can promote the development of digital technologies that would guide safe and effective prescription dru...[ Price : $8.95]
AstraZeneca and MedImmune say results from their Phase 3 MYSTIC trial involving Imfinzi (durvalumab) in lung cancer did not meet p...[ Price : $8.95]
Senator Mike Enzi (R-WY) writes FDA commissioner Scott Gottlieb expressing concern over eventual senior staff turnover and asking ...[ Price : $8.95]
In less than two weeks after submitting a supplemental BLA, FDA approves a Seattle Genetics submission for Adcetris (brentuximab v...[ Price : $8.95]
Pharmaceutical Manufacturing Research Services petitions FDA asking it to not approve any opioid product seeking an indication or ...[ Price : $8.95]
Federal Register notice: FDA announces the availability of its annual report entitled Report on the Performance of Drug and Biolog...