News

Soleno Therapeutics, Inc. has submitted a New Drug Application to the U.S. Food and Drug Administration for approval of DCCR extended-release tablets.

KBio has announced that the FDA has cleared its investigational new drug application for EV68-228-N, a human monoclonal IgG1 antibody targeting enterovirus D68 capsid. This antibody is intended for intravenous treatment of acute flaccid myelitis

Arch Biopartners Inc. has announced a significant advancement in its development of cilastatin, a drug candidate designed to prevent acute kidney injury

Concerto Biosciences, based in Cambridge, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to begin Phase 1 trials of Ensemble No.2

TRex Bio, Inc., a biotechnology company focused on deciphering human tissue immune biology to create innovative therapeutics, has announced a significant milestone. Its partner, Eli Lilly and Company, has initiated a Phase 1 first-in-human study of TRB-051

Roche has received approval from the European Commission for OCREVUS® (ocrelizumab) subcutaneous (SC) formulation, expanding its use to treat both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis

Exsilio Therapeutics, a biotechnology company focused on developing genomic medicines for a wide range of diseases, has announced its emergence from stealth mode after securing $82 million in Series A financing

Silence Therapeutics plc, a leading biotechnology company specializing in precision-engineered medicines for treating diseases, has announced a significant milestone in its partnership with Hansoh Pharmaceutical Group Company Limited

4D Molecular Therapeutics has obtained FDA clearance for its Investigational New Drug Application for 4D-175, an intravitreal genetic medicine utilizing the R100 vector, intended for treating geographic atrophy

Bristol Myers Squibb announced today that the U.S. Food and Drug Administration has granted accelerated approval for KRAZATI® in combination with cetuximab as a targeted treatment for adult patients