BioSpace News Archive

Rapid Micro Biosystems, Inc. (Nasdaq: RPID) (the “Company”), an innovative life sciences technology company providing mission critical automation solutions to facilitate the efficient manufacturing and fast, safe release of healthcare products, will release first quarter 2023 financial results prior to the market open on Friday, May 5, 2023.

The FDA has also recently granted an orphan drug designation (ODD) to GIVI-MPC.

BioCareSD, a specialty distributor of life-saving therapies, today announced that ALTUVIIIO [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], previously referred to as efanesoctocog alfa, is now available through their network.

AVITA Medical, Inc. announced that its automated device, RECELL GO, maintains the Food and Drug Administration Breakthrough Device designation for the treatment of acute wounds.

Alvotech announced that the U.S. Food and Drug Administration has issued a complete response letter for Alvotech’s Biologics License Application for AVT02, a high-concentration biosimilar candidate for Humira®.

Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration has issued a complete response letter to its partner Alvotech for the Biologics License Application for AVT02, a high-concentration biosimilar candidate for Humira®.

JEOL Ltd. announces launch of a new Cryogen Reclamation System for Nuclear Magnetic Resonance on April 14, 2023.