A Philadelphia jury delivers an $8 billion punitive verdict against Johnson & Johnson and its alleged improper marketing of the antispychotic drug Ris...
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for NADAs and ANADAs during April, May, and Jun...
Medtronic submits a PMA supplement for its InterStim Micro neurostimulator and InterStim SureScan MRI leads.
Federal Register notice: FDA sends to OMB an information collection extension entitled Investigational Device Exemptions Reports and Records.
FDA says that heparin manufacturers are reporting that African swine fever in China is not affecting the drugs manufacturing and distribution to the U...
Pfizer licenses Akcea Therapeutics Akcea-AngPtl3-L, an investigational antisense therapy being developed for certain cardiovascular and metabolic dise...
FDA approves a Pfenex Inc. 505(b)(2) NDA for PF708 (teriparatide injection) that referenced Eli Lillys Forteo, indicated for treating osteoporosis.
FDA approves a Galdermas Aklief (trifarotene) Cream for topically treating acne.