GSK says a Phase 2a study showed that GSK3036656, an investigational antitubercular agent, was well tolerated and showed early bactericidal activity w...
FDA approves an expanded use for GE Healthcares DaTscan (ioflupane I 123 injection) for use in patients with suspected dementia with Lewy Bodies.
FDA issues a five-item Form FDA-483 after conducting a pre-approval inspection of Lupins Nagpur, India Unit-2 injectable manufacturing facility 10-17-...
Some 165 healthcare-related organizations urge Congress to pass the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance Act before the ...
ECA Academy lists the top 10 GMP observations from 42 Warning Letters issued in FY 2022.
Federal Register notice: FDA issues an order debarring David Elias Mendoza for five years from importing or offering for import any drug into the U.S.
FDA says MITRE has updated a 2018 playbook explaining how healthcare organizations can prepare for and respond to cybersecurity incidents.
FDA is soliciting comments on a preliminary assessment that some naloxone products may be safe and effective when sold over-the-counter.
