Ganaxolone, marketed under the brand name Ztalmy, is FDA approved for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder (CDD) in individuals aged 2 years and older.

Jul 23rd latest updates in the global new drug development field, including progress in new drug research and development, transaction information, and partnership developments.

Pacritinib, with the generic name pacritinib [pak-RI-ti-nib], is approved by the FDA for the treatment of myelofibrosis in adults.

NexThera Co., Ltd. announced the submission of a Phase 1/2a Investigational New Drug application to the U.S. Food and Drug Administration for NT-101.

Ciltacabtagene autoleucel received FDA approval on February 28, 2022.

Celldex Therapeutics launches worldwide Phase 3 trial of Barzolvolimab for chronic spontaneous urticaria patients.

Mitapivat (Pyrukynd) was approved by the FDA on February 17, 2022.

Novo Holdings spearheads $100 million Series C investment in Asceneuron to propel innovative Alzheimer’s treatment forward.

The FDA approved Sutimlimab (Enjaymo) on February 4, 2022. This approval marked an important development for patients with CAD.

Biosyngen's BRG01 moves to Phase II trial, pioneering autologous EBV-specific CAR-T for recurrent/metastatic nasopharyngeal carcinoma solid tumors.

Faricimab ophthalmic was approved by the FDA on January 28, 2022. This approval covers its use in adults for treating neovascular age-related macular degeneration and diabetic macular edema.

Evommune, Inc. reported positive findings from its initial proof-of-concept study in humans with EVO756.