Page 33 - Priority Review News Today

Drug is intended for persons who are considered 'obese,' and deal with what is called chronic weight management issues.

The FDA approved Zepbound (tirzepatide) injection for chronic weight management in adults with obesity or overweight with at least one weight-related condition, for use in addition to a reduced calorie diet and increased physical activity.

Agreement reached with FDA on Phase 2 pivotal study design of RP-L301 for PKD to support accelerated approval; Initiating single-arm, 10-patient pivotal study with primary endpoint of ≥1.5 point Hgb improvement at 12 monthsInitiated Phase 2 pivotal trial of RP-A501 for Danon Disease following FDA alignmentInitiated...

- Continued strong commercial launch for ZYNTEGLO® and SKYSONA®; 22 patient starts across both programs to date – - Ended quarter with $227M in cash, cash equivalents, marketable securities and...

SOMERVILLE, Mass.--(BUSINESS WIRE)--Nov 7, 2023--

Real-Time Oncology Review (RTOR) Draft Guidance for Industry

Priority Review of resmetirom new drug application underway in the U.S. • $500 million financing provides Madrigal with funds to support a potential…

-Advisory Committee meeting for exagamglogene autotemcel (exa-cel) for the treatment of severe sickle cell disease (SCD) completed October 31, 202...

Data for a pair of studies presented at Kidney Week 2023 provide an overview of the effects of eGFR and how this might translate to potential long-term benefit in patients IgA nephropathy.

Oral presentation details efficacy, safety and health-related quality of life data in adult and pediatric patients with sickle cell disease treated with lovo-cel in HGB-206 Group C and HGB-210 ...