BioSpace News Archive

The FDA has one target action date and one advisory committee meeting scheduled for this week. It is also gearing up for an adcomm that could prove to be pivotal for neurodegenerative diseases.

The FDA has lifted the clinical hold it had placed on the Phase Ib study following the occurrence of hematological malignancies.

The FDA has approved Pfizer’s nasal spray, zavegepant, now to be marketed as Zavzpret, for the acute treatment of migraine in adults, the company announced Friday.

Partners CRISPR and ViaCyte (Vertex), and Genprex are pioneers in the quest to develop a gene therapy for Type 1 diabetes.

Diamyd Medical announced that Karin Rosén, M.D, Ph.D, San Francisco, will join the Board of Directors as an adjunct member, and be proposed for election to the Board at its next General Meeting of Shareholders.

Surglasses/Caduceus S from Taiwan Main Orthopaedic Biotechnology Co., Ltd. Achieves Landmark Success with Caduceus S AR Spine Navigation System for First Augmented Reality Surgery in the US using 2D C-Arm Imaging.

Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company with two innovative dermatology products that were launched in the U.S. and an innovative pipeline, today announced financial results for the full year ended December 31, 2022 and provided a corporate update.

Galera Therapeutics, Inc. today announced the presentation of a net treatment benefit analysis of Phase 3 ROMAN results at the 10th European Congress on Head and Neck Oncology (ECHNO), taking place March 8-11, 2023, in Lisbon, Portugal.

First Wave BioPharma, Inc. announced that the second patient was dosed in the Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).

Castle Biosciences, Inc. today announced that new data supporting its portfolio of skin cancer gene expression profile (GEP) tests will be showcased in one late-breaking oral presentation and three ePosters at the 2023 American Academy of Dermatology (AAD) Annual Meeting, being held March 17-21 in New Orleans.