Johnson & Johnson says an unexplained illness in a study participant has temporarily paused dosing in its Janssen Covid-19 vaccine candidate clinical ...
FDA says Optimal Health Stem Cell and Wellness Institute is marketing cellular products to treat several diseases and conditions without an approved B...
Pfizer and the German Breast Group say a Phase 3 study involving Ibrance (palbociclib) did not meet the primary endpoint of improved invasive disease-...
FDA grants CartiHeal a breakthrough device designation for the Agili-C implant and its use in treating cartilage lesions in arthritic and non-arthriti...
Two FDA advisory committees vote to support approval of an Alkermes NDA for ALKS 3831 (olanzapine/samidorphan), an oral atypical antipsychotic drug ca...
An FDA inspection of Colchester, VT-based Edge Pharma ends in a 17-page Form FDA 483 that cites numerous GMP deficiencies.
Federal Register notice: FDA announces 11/16 virtual public meeting entitled Potential Approach for Ranking of Antimicrobial Drugs According to Their ...
FDA issues Avenue Therapeutics a complete response letter due to safety concerns on its NDA for intravenous tramadol, indicated for treating patients ...