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University researchers worldwide urge FDA to reevaluate its use of a Boxed Warning in labeling for youth antidepressants after stu...[ Price : $8.95]
FDA reviewers appear unconvinced that a Stealth BioTherapeutics NDA for elamipretide, a mitochondria-targeted therapy for treating...[ Price : $8.95]
FDA grants a de novo marketing authorization for over-the-counter Healgen Rapid Check Covid-19/Flu A&B Antigen Test.[ Price : $8.95]
FDA releases the transcript from a two-day workshop held in conjunction with NIH on developing clinical outcome assessments to dem...[ Price : $8.95]
Two stakeholders recommend changes to an FDA draft guidance on treatment development for Bacillus Calmette-Guerin-Unresponsive Non...[ Price : $8.95]
FDA warns Indias MMC Healthcare about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA orders a clinical hold on Kezar Life Sciences IND for zetomipzomib and its investigational use in treating lupus nephritis.[ Price : $8.95]
FDA awards a priority review for an Indivior prior approval supplement for Sublocade (buprenorphine) extended-release injection fo...