FDA Review posts the Federal Register notices for the week ending 4/10/2020.
FDA issues an emergency use authorization to Terumo BCT and Marker Therapeutics for their Spectra Optia Apheresis System and Depuro D2000 Adsorption C...
FDA sends a Warning Letter to Earthly Wellness over unapproved and misbranded products related to Covid-19.
Novartis says it is seeking revised prescribing information with Beovu (brolucizumab) after confirming a safety signal involving retinal vasculitis an...
FDA issues a guidance entitled Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders Not Registered as...
FDA issues a second emergency use authorization for decontaminating compatible N95 or N95-equivalent respirators for reuse by health care workers in h...
FDA approves an AstraZeneca NDA for Koselugo (selumetinib) for treating of pediatric patients with neurofibromatosis type 1, a nervous system genetic ...