FDA releases the FDA-483 with two observations from a September inspection at the Sun Pharmaceutical facility in Punjab, India.
FDA releases the FDA-483 with three observations from an inspection at Indias Stride Pharma Science.
FDA grants HighTide Therapeutics a fast track designation for its investigational new drug, HTD1801, for treating patients with primary sclerosing cho...
CDRH chief medical officer William Maisel reaffirms the agencys intention to modernize its Quality System regulation for medical devices by harmonizin...
FDA approves an Obalon Therapeutics PMA supplement for the Obalon Touch Inflation System for use in inflating the Obalon Balloon, a swallowable gas-fi...
Endo extends the stay on a suit against FDA following an agency commitment to finalize its clinical need determination for vasopressin by 12/31.
FDA releases the FDA-483 with 16 observations from an inspection at the Pharm D Solutions outsourcing facility.
Neurelis files an NDA for Valtoco (diazepam nasal spray) as a treatment for epilepsy in patients six years and older who experience increased bouts of...