CDER Office of Medical Policy regulatory counsel Christopher Diamant explains why the new Patient Medication Information form was developed and how.
Two Polsinelli attorneys say the Supreme Courts refusal to hear an appeal in a labeling case helps manufacturers argue for preemption.
Patient nonprofit group Haystack Project confirms that former FDA principal deputy commissioner Janet Woodcock is playing an advisory role in its drug...
PhRMA gives FDA general and specific comments on a draft guidance on using data monitoring committees in clinical trials.
FDA approves a Genentech NDA for Alecensa (alectinib) for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase-po...
AbbVie reports positive top-line results from SELECT-GCA, a Phase 3, placebo-controlled study that showed the companys arthritis drug Rinvoq (upadacit...
Eli Lilly plans to file an NDA mid-year for tirzepatide and its use in treating obstructive sleep apnea; the drug is currently marketed as Zepbound fo...
Novartis asks FDA to impose limits on applications for generic forms of its Lutathera radioligand.
