Angering drugmakers, the Biden Administration announced Thursday that it’s supporting a previously unused, obscure and controversial regulatory authority called “march-in” rights to achieve lower prices on taxpayer-funded drugs deemed too…
Over the past week, the FDA issued final guidance on verification systems for certain prescription drugs under the Drug Supply Chain Security Act and draft guidances on the interim policy…
In this edition of Quick Notes, we review recent FDA drug approvals of Jaypirca for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma, Ogsiveo for desmoid tumors who…
Two cell-based gene therapies to treat sickle cell disease — Casgevy (exagamglogene autotemcel or exa-cel) and Lyfgenia (lovotibeglogene autotemcel or lovo-cel) — received FDA approval Friday, marking the first treatments…
Listen to an audio podcast of the November 28, 2023, FDA Drug Safety Communication, FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR,…
The FDA has released two draft guidances with interim policies addressing the FDA’s efforts to finalize bulk drug lists for compounders subject to 503A regulations and for compounders using bulk…
As action dates for two groundbreaking sickle cell gene therapies loom, U.S. Senator Bill Cassidy, MD (R-LA), is raising questions about the cost, and how these extremely expensive, but life-changing,…
As the comment period closed Wednesday on a trio of FDA draft guidances covering data requirements for 510(k) device submissions, industry trade group AdvaMed expressed its clear concerns that the…
AbbVie and Cerevel Therapeutics announced that AbbVie will buy Cerevel Therapeutics and its neuroscience pipeline of schizophrenia, Parkinson's disease, and mood disorder drugs that are in multiple clinical and preclinical…
Medtronic notified EOFlow on Dec. 6 that it exercised its right to terminate its agreement to acquire the company based on multiple breaches, according to a Securities Exchange Commission Form…