Ascendis Pharma and BioMarin Reach Global Settlement for Yuviwel

Shots: Ascendis Pharma has entered into a binding term sheet with BioMarin for a global settlement & license agreement covering Yuviwel (navepegritide) & related products, resolving ongoing litigation & disputes between the companies As per the deal, BioMarin will grant Ascendis a non-exclusive, worldwide, royalty-bearing license to research, develop, manufacture & commercialize navepegritide-related products without…

ByRidhi RastogiSeptember 1, 2026

The US FDA New Drug Approvals in February 2026

Shots: Approval momentum strengthened in February 2026, with the US FDA clearing four new therapies across dermatology, psychiatry, and rare pediatric disorders highlighting both volume and therapeutic impact. Four notable therapies crossed the regulatory finish line, Acrotech Biopharma and Otsuka Pharmaceutical’s Adquey for mild-to-moderate atopic dermatitis, Vanda Pharmaceuticals’ Bysanti for acute bipolar I disorder and schizophrenia, Immedica Pharma’s Loargys for ARG1-D–related hyperargininemia, and Ascendis Pharma’s Yuviwel to improve growth in children with achondroplasia Overall, February 2026 reflected…

ByDipanshu DixitMarch 10, 2026

Ascendis’ Yuviwel (Navepegritide) Receives the US FDA Accelerated Approval for Achondroplasia

Shots: FDA granted accelerated approval to Yuviwel (navepegritide, QW) to increase linear growth in children (≥2yrs.) with achondroplasia & open epiphyses; commercially available by Q2’26 Approval was based on extensive clinical data, incl. 3 PBO-controlled trials plus up to 3yrs. of OLE data, with the pivotal ApproaCH results published in JAMA Pediatrics Continued approval may…

ByRidhi RastogiMarch 2, 2026

Ascendis Pharma and BioMarin Reach Global Settlement for Yuviwel

The US FDA New Drug Approvals in February 2026

Ascendis’ Yuviwel (Navepegritide) Receives the US FDA Accelerated Approval for Achondroplasia

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