FDA grants GlaxoSmithKline an accelerated approval for Jemperli (dostarlimab-gxly) for adult patients with mismatch repair deficient recurrent or adva...
Attorney Andrew Tauber says two appeals court decisions in the last three years have strengthened implied preemption of state law drug cases.
FDA says a new pediatric electrocardiogram data warehouse already has almost 40,000 reports to be used in assessing cardiac risk to children through c...
FDA approves Boehringer Ingelheim and Eli Lillys diabetes drug Jardiance (empagliflozin) 10 mg for reducing the risk of cardiovascular death plus hosp...
FDA issues a letter to healthcare providers warning them to stop using and discard all ultrasound gels and lotions manufactured by Eco-Med Pharmaceuti...
FDA grants a breakthrough designation to Abiomeds Impella ECP expandable percutaneous heart pump.
The CDER State of Pharmaceutical Quality report for FY 2020 documents a slight decrease in the number of drug manufacturing sites and a slight decreas...
FDA tells Virpax Pharmaceuticals that it can proceed with additional research on MMS019, a high-density molecular masking spray under development for ...