Neurology

Cingulate submits NDA for CTx-1301 for ADHD treatment

Cingulate, a biopharmaceutical company, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its lead asset, CTx-1301 (dexmethylphenidate HCl), aimed at treating Attention Deficit/Hyperactivity Disorder (ADHD).

Kye Pharmaceuticals gains Health Canada approval for Dyanavel XR to treat ADHD

Kye Pharmaceuticals, a Canadian speciality pharmaceutical company, has received Health Canada's approval for its product, Dyanavel XR (amphetamine extended-release) tablets and oral suspension.

ProQR expands partnership with RSRT to advance Rett Syndrome therapy

ProQR Therapeutics has expanded its partnership with the Rett Syndrome Research Trust (RSRT), receiving an additional $8.1m in funding to support the advancement of Rett Syndrome therapy, AX-2402 into clinical trials.

FDA grants ODD to Ractigen Therapeutics’ RAG-21 for ALS treatment

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Ractigen Therapeutics' new therapy, RAG-21, targeting the fused in sarcoma (FUS) gene, for amyotrophic lateral sclerosis (ALS) treatment.

Asha Therapeutics secures grant for ALS therapeutic development

Asha Therapeutics has received a grant from the ALS Association through its Lawrence and Isabel Barnett Drug Development Program for advancing ASHA-624 to treat amyotrophic lateral sclerosis (ALS).

FDA issues CRL to PharmaTher’s ketamine ANDA

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to PharmaTher concerning its ketamine abbreviated new drug application (ANDA).

FDA grants orphan drug status to Papillon Therapeutics’ PPL-001

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Papillon Therapeutics’ PPL-001, aimed at treating Friedreich's ataxia, a rare neurodegenerative disorder.

FDA grants orphan drug status for RedHill’s opaganib for neuroblastoma

The US Food and Drug Administration (FDA) has granted orphan drug designation to RedHill Biopharma's opaganib for the treatment of neuroblastoma, a childhood cancer.

FDA approves Alpha Cognition’s ZUNVEYL for Alzheimer’s treatment

The US Food and Drug Administration (FDA) has approved Alpha Cognition's oral therapy, ZUNVEYL, for the treatment of mild-to-moderate Alzheimer's disease.