Zacks Investment Research on MSN

Rare rises as FDA accepts resubmitted BLA for Sanfilippo syndrome

Shares of Ultragenyx Pharmaceutical RARE rose 5% after the company announced that the FDA has accepted its resubmitted biologics license application (BLA) seeking accelerated approval for AAV gene ...
Monthly Prescribing Reference

FDA to Review Resubmitted Dupilumab sBLA for Chronic Spontaneous Urticaria

The Food and Drug Administration (FDA) has accepted for review the resubmitted supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) for the treatment of chronic spontaneous ...
Healio

FDA receives resubmitted NDA for sotagliflozin to treat type 1 diabetes and CKD

Please provide your email address to receive an email when new articles are posted on . The FDA declined to approve sotagliflozin for type 1 diabetes in a complete response letter issued in March 2019 ...
Monthly Prescribing Reference

NDA for Twirla Contraceptive Patch Resubmitted to FDA

Agile Therapeutics has resubmitted to the Food and Drug Administration (FDA) the New Drug Application (NDA) for its product, Twirla, an investigational low-dose combined hormonal contraceptive patch ...
Becker's ASC

Which physicians have the most claims denied, resubmitted? A specialty breakdown

At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives ...