The National Association for Rare Disorders says a study it commissioned shows that the FDA orphan exclusivity designation is working as intended and ...
Media accounts say some drug companies are greeting the new year by raising prices on prescription medications.
Researchers say the REDUCE-IT study demonstrates that patients with elevated triglyceride levels despite use of statins benefit from receiving 2 g of ...
The Supreme Court schedules oral arguments in a Merck appeal of a 3rd Circuit decision allowing state failure-to-warn claims involving the companys Fo...
FDA grants Bruin Biometrics de novo clearance to market the SEM Scanner, a wireless handheld device that is indicated for use as an adjunct to the sta...
FDA says a Phase 2/3 efficacy trial for Wave Life Sciences DMD drug suvodirsen will be in the agencys pilot program for complex innovative trial desig...
FDA approves an expanded indication for Bristol-Myers Squibbs Sprycel (dasatinib) tablets to include treating pediatric patients one year of age and o...
FDA sends Warning Letters to Cao Medical Equipment Co., Gentech and Hybrid Pharma.