FDA sends Aldeyra Therapeutics a complete response letter on its NDA for reproxalap, an investigational drug candidate for treating dry eye disease.
Novartis recalls two lots of its Sandimmune oral solution (cyclosporine) 100 mg/mL due to crystal formation observed in some bottles.
Federal Register notice: FDA extends the comment period on a 10/24 notice on the revised draft guidance entitled Communications From Firms to Health C...
FDA withdraws its membership in the 32-member medical device Global Harmonization Working Party after failing to persuade the organization to align wi...
Federal Register notice: FDA sends to OMB an information collection extension entitled Good Laboratory Practice Requirements for Nonclinical Laborator...
Unomedical recalls certain VariSoft Infusion Sets due to the risk that the devices connector may detach from the set.
FDA accepts for priority review an Abeona Therapeutics BLA for pz-cel (prademagene zamikeracel) for treating patients with recessive dystrophic epider...
Federal Register notice: FDA makes available a final guidance entitled Covid-19: Developing Drugs and Biological Products for Treatment or Prevention....
