Drug Discovery & Development

Renaissance Pharma secures FDA Fast Track Designation and IND clearance for Daretabart in high-risk neuroblastoma

The US Food and Drug Administration (FDA) has granted Fast Track Designation for Daretabart (hu1418K322A), a novel anti-GD2 monoclonal antibody in development for the...

Oragenics doses first patient in phase 2a clinical trial of drug for mild traumatic brain injury

Oragenics, a clinical-stage biotechnology company developing brain-targeted therapeutics through proprietary intranasal delivery technology, has announced that the first patient has been dosed in its...

Bracco invests in GMP manufacturing facility for cell therapy products

Bracco Imaging, a global pharmaceutical company that develops, manufactures, and markets innovative healthcare solutions, announced an upgrade of its manufacturing site in Geneva to...

Virica Biotech and Fujifilm Biosciences collaborate to develop production enhancers

Virica Biotech, a cell enhancer company specialising in Viral Sensitizers for viral vector manufacturing, has announced receipt of advisory services and funding from the...

FDA approves new high dose regimen of Spinraza (nusinersen) for spinal muscular atrophy

Biogen has announced that the high dose regimen of Spinraza® (nusinersen), which is comprised of 50 mg/5 mL and 28 mg/5 mL doses, has been approved...

Apotex receives first US FDA tentative approval for a generic version of Ozempic (semaglutide injection)

Apotex has announced it has received the first US Food and Drug Administration (FDA) Tentative Approval for its Abbreviated New Drug Application (ANDA) for...

Lynk Pharmaceuticals announces NDA acceptance for zemprocitinib

Lynk Pharmaceuticals, a clinical-stage innovative drug development company focused on therapies for immune and inflammatory diseases, has announced that the New Drug Application (NDA)...

Lilly to acquire Centessa Pharmaceuticals to advance treatments for sleep-wake disorders

Eli Lilly and Company and Centessa Pharmaceuticals, a clinical-stage company developing a new class of medicines for the treatment of excessive daytime sleepiness and other...
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