Medtronic describes several actions to increase its manufacturing of ventilators to help patients hospitalized with Covid-19.
FDA says it is concerned that some firms are falsely claiming that their serological tests are FDA approved/authorized or that they can diagnose Covid...
FDA grants EicOsis a Fast Track designation for its lead drug candidate, EC5026, for treating neuropathic pain.
Hyman, Phelps & McNamara outlines key provisions in the OTC monograph reform provisions included in the coronavirus recovery legislation.
Two House lawmakers ask FDA to provide information about Covid-19 test accuracy in the wake of testing failures earlier this year involving Centers fo...
The Judge Rotenberg Center asks FDA to delay indefinitely the effective dates for a final regulation banning the use of electrical stimulation devices...
Pfizer and BioNTech say they are working together on clinical trials and manufacturing capacity for an mRNA Covid-19 vaccine.
Seneca Biopharma says FDA has provided significant guidance on the design of a Phase 3 trial for the companys neural stem therapy intended to treat AL...