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).
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to PharmaTher concerning its ketamine abbreviated new drug application (ANDA).
Acumen Pharmaceuticals has announced the extension of its collaboration with Lonza to facilitate the anticipated commercial launch of sabirnetug, a new therapeutic for early Alzheimer's disease (AD).
Sanofi India Limited and Sanofi Healthcare India (together called “Sanofi India”) have entered into an exclusive partnership with Cipla, focusing on the expansion of its central nervous system (CNS) product portfolio in the Indian market.
Guangzhou Fermion Technology (Fermion) has received approval from China’s National Medical Products Administration (NMPA) for its Investigational New Drug (IND) application for FZ008-145.
CuraSen Therapeutics has secured up to $5.8m from the Alzheimer’s Drug Discovery Foundation (ADDF) to progress CST-3056 for the treatment of Alzheimer’s disease.
US-based amyloid diseases treatment solutions developer AltPep has raised $52.9m in its Series B investment round led by Senator Investment Group.
Ractigen Therapeutics has received orphan drug designation from the US Food and Drug Administration (FDA) for its new therapeutic siRNA, RAG-17, to treat Amyotrophic Lateral Sclerosis (ALS).
Ryne Biotechnology has received a $4m Clinical Stage Research Program (CLIN1) grant from the California Institute for Regenerative Medicine (CIRM) to advance its lead candidate RNDP-001.
Astex and Cardiff University Medicines Discovery Institute (MDI) have announced a multi-year research collaboration which is aimed at identifying new drugs for the treatment of neurodegenerative diseases.
The European Medicines Agency (EMA) has accepted for review Eisai and Biogen’s marketing authorization application (MAA) submitted for lecanemab to treat early Alzheimer’s disease (AD).