FDA grants Lantern Pharma an orphan drug designation for LP-184 and its use in treating glioblastoma multiforme and other malignant gliomas.
Federal Register notice: FDA announces that it has revoked the Emergency Use Authorization issued to Curative Inc. for its Curative SARS-Cov-2 Assay b...
Federal Register notice: FDA makes available two draft device-specific guidance documents for the Safety and Performance Based Pathway one on denture...
FDA Review posts the Federal Register notices for the week ending 8/27/2021.
FDA Review posts product approval summaries for the week ending 8/27/2021.
Roche withdraws its accelerated approval for Tecentriq (atezolizumab) in combination with chemotherapy for treating adults with unresectable locally a...
Federal Register notice: FDA withdraws the approval of a Breckenridge Pharmaceutical ANDA for solifenacin succinate tablets (5mg and 10mg) after the c...