Calliditas Therapeutics AB has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its drug setanaxib for the treatment of Alport syndrome.

Nexus Pharmaceuticals, LLC has announced its receipt of approval from the U.S. Food and Drug Administration (FDA) for Fluorescein Injection, USP. Usman Ahmed, President and Chief Executive Officer of Nexus Pharmaceuticals, expressed enthusiasm about this FDA approval, stating

Chrysalis BioTherapeutics, Inc. has received permission from the U.S. Food and Drug Administration (FDA) to commence human clinical trials focused on treating acute lung failure. With the approval of its Investigational New Drug (IND) Application

AcuraStem, a biotechnology company focused on developing treatments for neurodegenerative diseases, has entered into a licensing agreement with Takeda to collaborate on the development and commercialization of AcuraStem's PIKFYVE targeted therapeutics, including AS-202, an antisense oligonucleotide (ASO) designed for the treatment of Amyotrophic Lateral Sclerosis (ALS).

Chime Biologics, a prominent Contract Development and Manufacturing Organization (CDMO) specializing in biologics, has entered into a strategic cooperation agreement with Kings Pharm. Under this agreement, Chime Biologics will utilize its extensive expertise in biosimilar projects to provide Kings Pharm

The U.S. Food and Drug Administration (FDA) has approved Jardiance® (empagliflozin) 10 mg tablets to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR)

Shanghai Henlius Biotech, Inc. (2696. HK) announced that the new drug application (NDA) for new indication of HANSIZHUANG (serplulimab injection), an innovative anti-PD-1 monoclonal antibody

Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical firm specializing in innovative inhaled therapies for serious pulmonary and central nervous system disorders, has announced that the U.S. Food and Drug Administration (FDA) has accepted the investigational new drug (IND) application for PUR3100 and issued a study may proceed letter.

Brain diagnostics innovator BrainScope has secured new investment from the Alzheimer’s Drug Discovery Foundation (ADDF) as part of its ongoing Series B equity financing round. This investment will support the development of an Artificial Intelligence / Machine Learning-derived brain-activity-based biomarker aimed at predicting the future onset of Alzheimer’s disease.

Unravel Biosciences, Inc. (referred to as "Unravel") has unveiled a pioneering initiative known as rareSHIFT™, aimed at expediting patient-centric drug discovery and translation with unmatched speed.