FDA issues Stealth BioTherapeutics a complete response letter that proposes the company resubmit its elamipretide NDA to seek accelerated approval for...
FDA approves an Alcon NDA for Tryptyr (acoltremon ophthalmic solution) 0.003% for treating the signs and symptoms of dry eye disease.
Former McKinsey & Company senior partner Martin Elling is sentenced to six months in federal prison, supervised release after incarceration, community...
FDA warns Marburg, Germany-based DRG Instruments that it is marketing diagnostic devices that do not have FDA approval and are being manufactured with...
Complaining about a lack of information from the department, top Democrats on the House Energy and Commerce Committee ask HHS Secretary Robert F. Kenn...
FDA publishes two guidances relating to the CDRH/CBER Q-submission process.
GSK plans to submit an NDA in the second half of the year after it and Spero Therapeutics announced that they will end their Phase 3 PIVOT-PO clinical...
CDERs Accelerating Rare Disease Cures online newsletter says there were 26 orphan drug approvals in 2024 and lists four approvals already in 2025.
