FDA approves new pain medication as an alternative to opioids: What to know about Journavx
The FDA on Thursday approved a new class of pain medication that provides an alternative to opioids. It will be sold under ...
FDA approves new painkiller designed to avoid opioid addiction risk
The U.S. Food and Drug Administration said it approved Vertex Pharmaceuticals’ Journavx for short-term pain that often ...
New Pain Drug Gets FDA Nod as Safer Alternative to Addictive Opioids
Vertex Pharmaceuticals Inc. gained US approval for the first new type of painkiller in more than two decades, paving the way ...
JD Supra20h
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...
Teva's Growth Profile Looks Strong From Innovative Portfolio, Biosimilar Approvals and Deep Pipeline
We assign Teva a Morningstar Uncertainty Rating of High, which largely reflects our quantitative analysis of the firm, based on the return ranges used by our star rating system, as well as our ...
MindMed's LSD Anxiety Drug: Revisiting, Rethinking, But Maintaining My 'Hold' Call
Inc. stock despite strong Phase 2b data. Click for my updated look at MNMD stock and its market opportunities.
Cure Today2d
FDA Accepts sNDA for Welireg in Advanced Pheochromocytoma and Paraganglioma
The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic ...
Targeted Oncology2d
FDA Grants Belzutifan Priority Review For Advanced Pheochromocytoma and Paraganglioma
The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date ...
BioSpace2d
Atara to Cut Half Its Workforce Following FDA-Related Setbacks
Atara Biotherapeutics’ layoffs could leave the biotech with around 80 employees. The cuts follow news that the FDA rejected ...
thecardiologyadvisor.com3d
FDA Extends Review of Elamipretide for Barth Syndrome
The FDA has extended the review period for the New Drug Application for elamipretide for the treatment of Barth syndrome.
Pharm Exec3d
Challenges to Navigating the Pharmaceutical Regulatory Landscape
In the United States, the biomedical industry encounters numerous regulatory challenges in conducting nonclinical and ...