[ Price : $8.95]
FDA publishes a draft guidance on quality considerations for ophthalmic drug products indicated for topical delivery in and around...[ Price : $8.95]
Citing inspection findings that need to be resolved, FDA sends Alvotech a complete response letter for its BLA for AVT04, a biosim...[ Price : $8.95]
Federal Register notice: FDA determines that Novartis Pharmaceuticals Mekinist (trametinib dimethyl sulfoxide) tablets (1 mg) were...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Allegations of Regulatory Misconduct Volunt...[ Price : $8.95]
PhRMA suggests that FDA revise a draft guidance on QTc labeling to incorporate an International Council on Harmonization guideline...[ Price : $8.95]
Reporting positive data from a Phase 3 study on mirikizumab in Crohns disease, Eli Lilly says it will seek FDA approval for the dr...[ Price : $8.95]
Rep. Abigail Spanberger and 14 Democratic colleagues ask FDA and DEA for more information on their work to resolve shortages of AD...[ Price : $8.95]
FDA lifts a clinical hold against PepGen that will allow the company to begin the Phase 1 FREEDOM-DM1 study of PGN-EDODM1 in patie...