Orthofix Medical Inc. a leading global spine and orthopedics company, announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Rodeo™ Telescopic Nail.
SN Bioscience Co. Ltd. announced on May 7 that the FDA has granted Fast Track Designation for small cell lung cancer (SCLC) for SNB-101 (API: SN-38), a new drug for polymer nanoparticle anticancer under clinical trial. SNB-101 was designated as an orphan drug for small cell lung cancer and pancreatic cancer in July of last year and February of this year, respectively. By receiving fast-track designation this time, it is evaluated that it has laid the groundwork that can be commercialized immediately after completion of phase 2 clinical trials.
ExcellGene SA, a leading Swiss biotech service provider specializing in mammalian cell line development for more than two decades, proudly announces its strategic collaboration with Cytovance Biologics, a renowned Contract Development and Manufacturing Organization (CDMO) based in the USA.
Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as "Leads Biolabs") announced that LBL-024, an anti-PD-L1/4-1BB bispecific antibody independently developed by Leads Biolabs with global intellectual property rights has received approval to conduct the single-arm pivotal study for registration and market.
Axion BioSystems announced new Maestro Volt™, an affordable benchtop microelectrode array (MEA) system designed to meet the demands of academic labs with lower throughput needs and limited budgets.
Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Eptifibatide for Injection in the United States as a therapeutic equivalent generic for Integrilin® for Injection (Eptifibatide) approved by the U.S. Food and Drug Administration.
Cold Box Express, Inc. (CBX) has announced a rebranding of both the company and its product the ClimateCrate™ (formerly COLD BOX). While the corporate company name remains Cold Box Express, Inc., the evolution to CBX simplifies the logo and helps distinguish the company from its product offerings.
Octapharma USA, Inc. announced the U.S. Food and Drug Administration (FDA) has granted orphan drug exclusivity for wilate®, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous Injection, for routine prophylaxis to reduce the frequency of bleeding episodes in adults and children 6 years of age and older with von Willebrand disease (VWD).
Rubedo Life Sciences, a biopharmaceutical company committed to developing first-in-class therapies targeting senescent cells which drive age-related diseases, announced the closing of a $40M Series A financing round.
ImmunityBio, Inc.an immunotherapy company, announced that the U.S. Food and Drug Administration (FDA) has approved ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.