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, a Canadian speciality pharmaceutical company, has received Health Canada's approval for its product, Dyanavel XR (amphetamine extended-release) tablets and oral suspension.
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.
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 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).
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to PharmaTher concerning its ketamine abbreviated new drug application (ANDA).
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.
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.
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.
BioArctic's partner Eisai has announced that Leqembi, has received approval in Israel for the treatment of Alzheimer's disease (AD), specifically for patients with mild cognitive impairment or mild dementia, the same stages targeted in clinical trials.
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