Friday, September 29, 2023

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Biotechnology News Magazine

FDA Updates

Unravel Biosciences Reports Positive Feedback from FDA Pre-Ind Meeting on RVL001 RETT Syndrome Program

Richard Novak, Ph.D., Unravel Bioscience Co-Founder and CEO. "The successful completion of this key development milestone provides a great validation of Unravel's ability to rapidly move promising therapies into the clinic, much faster than most conventional approaches to drug development."

ADMA BioCenters Receives FDA Approval for its Eighth Plasma Collection Center, Located in Hammond, LA

In addition, ADMA BioCenters remains on-track to have all 10 plasma collection centers FDA-licensed by year-end 2023.

ImmPACT Bio Announces FDA Clearance of IND for Novel Bispecific CAR to Treat Aggressive B-cell Lymphoma

Results from an investigator-led study evaluating this CAR T-cell therapy demonstrated that 70 percent of patients achieved a complete response with significant durability of remission. These initial efficacy results combined with the favorable safety profile show that IMPT-314 could potentially be a best-in-class treatment for patients with B-cell lymphomas.

DualityBio Announces DB-1303 Granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the Treatment of Advanced, Recurrent or Metastatic Endometrial...

DualityBio is currently evaluating DB-1303 in an ongoing Phase I/IIa clinical trial for preliminary safety and efficacy in advanced/metastatic solid tumors with Her2 expression, including both HER2 positive and HER2 low patients.  

Neurelis Announces Filing of Its Investigational New Drug Application for NRL-1049, a Rho Kinase (Rock) Inhibitor with Potential to Treat Cerebral Cavernous Malformations

"We are excited that the preclinical studies have shown that NRL-1049 is safe and efficacious in animal models," said Enrique Carrazana, M.D., Neurelis Chief Medical Officer. "Based on the significance of these data, Neurelis is developing further studies in humans to assess the safety of NRL-1049 in the treatment of chronic and acute conditions that affect the functioning of the blood-brain barrier. If successfully developed and approved, NRL-1049 has the potential to provide relief to people suffering from CCMs."

US FDA Grants Breakthrough Designation for Blood Test to Help Diagnose Inaccessible Brain Tumors

The FDA has granted 'Breakthrough Device Designation' for its 'TriNetra™-Glio', a blood test to help in the diagnosis of brain tumors.