BioSpace News Archive

Airway Management, Dallas-based manufacturer of the most independently studied custom oral appliance in the world, announces their non-custom myTAP™ is now proven equally effective to their custom TAP™.

FDA 510(k) clearance will expand the reach of Rune Labs’ precision neurology platform to millions of people with or at risk of developing Parkinson’s disease, enabling data-driven routine care and accelerating clinical trials for new Parkinson’s therapeutics.

Artiva Biotherapeutics, Inc., an oncology company whose mission is to deliver highly effective, off-the-shelf allogeneic, natural killer cell therapies that are safe and accessible to cancer patients, announced the official opening of the company’s U.S. corporate headquarters and R&D laboratory facilities at the Alexandria Tech Center in San Diego.

Dermata Therapeutics, Inc., a clinical-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions, announced it has completed enrollment of its Phase 2 trial of DMT310 for the once-weekly treatment of moderate-to-severe rosacea.

Dompé farmaceutici S.p.A (“Dompé”) today announced results from its Phase 2 clinical trial demonstrating that, in patients in severe COVID-19 Pneumonia, Reparixin led to an improvement in clinical outcomes when compared with the standard of care, a larger phase 3 clinical study is needed to confirm these results.

In our continued efforts to establish long-term partnership with our clients, FDAQRC is expanding in Current Good Manufacturing Practices (cGMP) by including a broad range of comprehensive quality and regulatory compliance services.

Contrast agents used in MRI scans to improve the clarity of imaging for diagnostic accuracy, accumulate in the brain and body of every patient, and carry an FDA “black box” warning about gadolinium, a heavy metal they use to generate contrast.

Rentschler Biopharma, a leading global contract development and manufacturing organization, provided an update on progress at Rentschler ATMP Ltd., the Company’s dedicated cell and gene therapy facility located in Stevenage, UK, including an important key hire.

Amsterdam, the Netherlands – Royal Philips announced that it will repurchase up to 3.2 million shares to cover certain of its obligations arising from its long-term incentive and employee stock purchase plans.

On June 14-15, the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee will meet to consider granting Emergency Use Authorization (EUA) for COVID-19 vaccinations for children under age 5.