SCG Cell Therapy Pte Ltd (SCG), a biotechnology company developing novel immunotherapies for infectious diseases and their associated cancers, today anno...
Cepheid announced today that it has received FDA De Novo marketing authorization and Clinical Laboratory Improvement Amendments (CLIA) Waiver approval for ...
Regulatory review of the single-dose CHIKV VLP vaccine candidate for immunization to prevent disease caused by chikungunya virus infection in individua...
The status is based on preclinical data and data from an ongoing phase 1/2 study for BNT324/DB-1311; preliminary phase 1/2 clinical data showed anti-tu...
Takeda announced that LIVTENCITY® (maribavir) has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for post-transplant cy...
AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for adults with moderately to severely ac...
Milestone Scientific , a leading developer of computerized drug delivery instruments that provide painless and precise injections, announces that it has ...
Shanghai Junshi Biosciences , a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of nov...
Danish MedTech company, °MEQU announces 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) of the °M Warmer System - a ...
Eisai Co., and Biogen announced that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Supplemental Biologics License Applicat...
The test uses highly sensitive PCR technology, requiring only a single nasal-swab sample to provide rapid, accurate qualitative detection and different...
Moderna's Investigational Therapeutic for Methylmalonic Acidemia (mRNA-3705) Selected by U.S. Food & Drug Administration for START Pilot Program ...
Bio-Thera Solutions , a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, announced th...
START is a pilot program newly launched jointly by the FDA CDER and CBER divisions to further accelerate the development of novel drug and biological p...
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