[ Price : $8.95]
FDA accepts for review an Immunomedics resubmitted BLA seeking accelerated approval for sacituzumab govitecan, indicated for treat...[ Price : $8.95]
Stakeholders suggest areas where more clarification is needed in an FDA draft guidance on how to identify what is important to pat...[ Price : $8.95]
Journal authors, including FDAers, analyze therapeutic modalities that could be used in developing new orphan drugs.[ Price : $8.95]
Stakeholders comment on an FDA draft guidance on postmarketing studies and clinical trials.[ Price : $8.95]
FDA again issues Correvio Pharma a complete response letter on its NDA for Brinavess (vernakalant IV), an anti-arrhythmic drug for...[ Price : $8.95]
FDA approves an Eisai NDA for Dayvigo (lemborexant) 5 mg and 10 mg for treating adult patients with insomnia.[ Price : $8.95]
FDA publishes a draft guidance recommending how to approach bridging in NDAs or BLAs for some drug-device and biologic-device comb...[ Price : $8.95]
FDA issues a draft guidance to help applicants filing NDAs or BLAs or their supplements understand the evidence to be provided to ...