Federal Register notice: FDA sends to OMB an information collection extension entitled Expedited Programs for Serious Conditions Drugs and Biologics....
Eli Lilly plans to file an NDA mid-year for tirzepatide and its use in treating obstructive sleep apnea; the drug is currently marketed as Zepbound fo...
Novartis asks FDA to impose limits on applications for generic forms of its Lutathera radioligand.
FDA issues Sun Pharmaceutical Industries a six-item Form-483 following a two-week December inspection at the firms Dadra, Dadra & Nagar Haveli and Dam...
FDA releases the form FDA-483 with three observations from an inspection at a Eugia Steriles drug manufacturing facility in Andhra Pradesh, India, the...
FDA posts its official notice that Oncopeptides accelerated-approval multiple myeloma drug Pepaxto (melphalan flufenamide) has been withdrawn after fa...
FDA denies a Hyman, Phelps & McNamara petition seeking permission to submit an ANDA for generic Imodium with two different strengths than the referenc...
CDRH releases reports on its commitment to medical device innovation and safety.
