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FDA grants Spinologics a breakthrough device designation for its MIScoli system, a vertebral body tethering device to treat scolio...[ Price : $8.95]
FDA grants Roche an emergency use authorization for its cobas SARS-CoV-2 nucleic acid test for use on the cobas Liat System.[ Price : $8.95]
FDA sends Orphazyme a complete response letter on an NDA for arimoclomol, a heat shock protein amplifier intended for treating Nie...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Premenopausal Women with Breast Cancer: Developing Drugs fo...[ Price : $8.95]
Federal Register notice: FDA announces a 9/21 public workshop entitled Considerations for Progressive Multifocal Leukoencephalopat...[ Price : $8.95]
Bausch Health petitions FDA to apply its specified bioequivalence and pharmaceutical equivalence criteria to the approval of any A...[ Price : $8.95]
FDA issues a draft guidance to clarify whether activities performed on medical devices are likely remanufacturing.[ Price : $8.95]
FDA says Philips has notified customers about possible risks associated with the sound abatement foam used in three of its product...