TipRanks on MSN

FDA Calendar: These Are the Upcoming FDA Drug Approvals

By the end of this month, two pharmaceutical firms are set to receive a decision on their drug approval applications from the U.S. Food and Drug ...
Nasdaq

Mesoblast Secures FDA Orphan-Drug Approval For Ryoncil

(RTTNews) - Mesoblast (MESO, MSB.AX) announced that it has received seven years of orphan-drug exclusive approval from U.S. Food and Drug Administration for Ryoncil (remestemcel-L) for treatment of ...
Healio

FDA approves Dupixent for bullous pemphigoid

Please provide your email address to receive an email when new articles are posted on . Dupixent previously received priority review and orphan drug designation from the FDA for bullous pemphigoid.
Cure Today

FDA Grants Orphan Drug Status to Cintredekin Besudotox for Glioblastoma

Cintredekin besudotox targets IL-13 alpha-2 receptor in glioblastoma, aiming to spare healthy brain tissue while destroying cancer cells. Orphan drug designation offers benefits like lower fees and ...
JD Supra

New FDA approval process promotes development of rare disease gene therapies

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...
Cure Today

FDA Grants Accelerated Approval to Lynozyfic for Multiple Myeloma

Lynozyfic is approved for relapsed/refractory multiple myeloma after four prior therapies, showing a 70% response rate in the LINKER-MM1 trial. Life-threatening side effects, including cytokine ...
JD Supra

Shutdown Updates, FDA Orphan Drug Leader Reassigned as CMS Issues Orphan Drugs Guidance, FDA to Host Allergen Threshold Meeting, and Commissioner’s National Priority Review ...

Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics ...
Medscape

New FDA Orphan Drugs: iPlex, Cethrin, Brivaracetam

Dec. 13, 2005 -- The US Food and Drug Administration (FDA) has approved orphan drug status for mecasermin rinfabate [rDNA origin] subcutaneous injection in the treatment of children with severe ...