Cardiol Therapeutics: Bargain Stock Price With Share Price Appreciation Catalysts
Cardiol Therapeutics' CardiolRx shows promise in treating heart conditions. Click here to read more about CRDL stock and why ...
Monthly Prescribing Reference11h
FDA Approves Denosumab Biosimilars Ospomyv and Xbryk
The approval was based on a comprehensive clinical data package, which included a single phase 1 trial and a phase 3 trial.
News Medical13h
FDA-approved osteoporosis drug may treat rare genetic heart disease
A research team co-led by scientists at the University of Arizona College of Medicine – Tucson found that an osteoporosis drug might counter a rare genetic mutation underlying a type of heart disease.
FDA approves tablet form of Evrysdi for spinal muscular atrophy
The U.S. Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for ...
Cure Today16h
The FDA Grants ODD to OPN-6602 For Relapsed/Refractory Myeloma
The FDA has granted orphan drug designation to the oral agent OPN-6602 for the treatment of patients with relapsed or ...
precisionmedicineonline16h
FDA Grants Priority Review to Ultragenyx's BLA for Sanfilippo Syndrome Type A Gene Therapy
The firm is seeking accelerated approval for UX111 using reductions in levels of heparan sulfate in cerebrospinal fluid as a surrogate endpoint.
Teva and Alvotech get FDA review acceptance for its proposed biosimilar to Eylea
Alvotech and Teva Pharmaceuticals said on Tuesday that the U.S. FDA has accepted for review a Biologics License Application ...
Jaguar Health, Inc.: Jaguar Health Extends Collaboration for Possible Tropical Disease Priority Review Voucher and Cholera Indication for NP-300
Priority Review Vouchers (PRVs) are transferable and, in past transactions by other companies, have sold for prices up to $350 million1.3 to 4 million cholera cases and 21,000 to 143,000 cholera-relat ...
Contract Pharma18h
sBLA for Dupixent Accepted by FDA for Priority Review
The US Food and Drug Administration (FDA) has accepted for priority review Sanofi’s supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults with bullous pemphigoid ...
Chimerix’s NDA for dordaviprone accepted by FDA
Chimerix (CMRX) announced the FDA has accepted its New Drug Application, or NDA, seeking accelerated approval for dordaviprone as a treatment ...
Sanofi: Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoid
Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoid If approved, Dupixent would be the first and only targeted medicine to treat BP in the US; FDA decision ...