Teva’s Ecopipam NDA Wins FDA Priority Review
PARSIPPANY, N.J., August 19, 2026 Teva Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted its...
pediatric neurology
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Santhera Pharmaceuticals Gains EU Boost for AGAMREE Expansion
PRATTELN, Switzerland, April 27, 2026 Santhera Pharmaceuticals has achieved a significant regulatory milestone with the European Medicines Agency’s (EMA)...
Acadia Expands DAYBUE STIX Access for Rett Syndrome
San Diego, California, USA, April 7, 2026 Broad U.S. Availability Expands Patient Access In a major advancement for rare...
Praxis Precision Medicines Gains FDA Priority Review Boost
BOSTON, March 30, 2026 Praxis Precision Medicines has achieved a major regulatory milestone as the U.S. Food and Drug...
Ultragenyx Gene Therapy Shows Durable Gains in MPS IIIA
NOVATO, Calif., February 3, 2026 — Ultragenyx Pharmaceutical Inc. has reported positive long-term clinical data for UX111, an investigational...
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Merz Submits EMA Application for Pediatric XEOMIN Spasticity Use
FRANKFURT AM MAIN, GERMANY | January 26, 2026 — Merz Therapeutics has completed and submitted a regulatory application to...
FDA Breakthrough Status Advances Rett Syndrome Gene Therapy
DALLAS, Oct. 2, 2025 — The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to TSHA-102,...
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