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 ...
FDA approves Alexion Pharmaceuticals Ultomiris (ravulizumab-cwvz) 100 mg/mL, a new dosing formulation for treating adults with paroxysmal nocturnal he...