A: The majority of inquiries are related to regulatory issues, such as the drug review process, and are classified as follows: investigational new drugs (16%), new drugs (13%), generic drugs (17% ...

Multiple myeloma is the second most common hematologic malignancy, but there is a treatment gap for patients with disease ...

In a tough fundraising space, cell therapy biotechs pursuing autoimmune indications review staffing to ensure the right ...

today announced that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) Application for CLN-978 and its global Phase 1 clinical trial may proceed in ...

Fast Track Designation is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need. Fast Track Designation for LP-184 (STAR-001 ...

Individuals with STXBP1 mutations can develop treatment-resistant seizures, severe developmental delay and intellectual disabilities, motor abnormalities, and sudden unexpected death in epilepsy.

Leal Therapeutics has secured yet another multi-million financing deal as the Worcester-based biotechnology startup has ...

Novavax has said its previous COVID-19 and influenza trials have shown no signs of motor neuropathy, and the clinical hold ...

In the field of myelodysplastic syndromes (MDS), there are a number of investigational studies designed with the hope of ...

Vertex may have pivoted away from the space, but candidates in development by Arrowhead/Takeda, Wave, Korro and others could ...

Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the ...

LP-184 is currently in a Phase 1A clinical trial designed to evaluate the safety and tolerability of the synthetically lethal investigational ... to development of new drugs in the treatment ...