Invivoscribe files sPMA with the FDA for use of the LeukoStrat CDx FLT3 Mutation Assay to Select Patients with Newly Diagnosed FLT3-ITD Positive AML

Invivoscribe is pleased to announce that they have filed a supplemental Pre-Market Approval (sPMA) submission with the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) for the use of the LeukoStrat® CDx FLT3 Mutation Assay as the companion diagnostic for Daiichi Sankyo’s investigational drug quizartinib. The assay is used for the identification of […]

thaipr.net

25 ต.ค. 65

AFTER 30 YEARS — NEW GUIDELINES FOR WEIGHT-LOSS SURGERY

Medical Groups Replace Outdated Consensus Statement that  Overly Restricts Access to Modern-Day Weight-Loss Surgery Two of the world’s leading authorities on bariatric and metabolic surgery have issued new evidence-based clinical guidelines that among a slew of recommendations expand patient eligibility for weight-loss surgery and endorse metabolic surgery for patients with type 2 diabetes beginning at a […]

thaipr.net

25 ต.ค. 65

MedAlliance to be Acquired by Cordis

Swiss-based medical technology company MedAlliance has announced it has entered into an agreement with Cordis for an acquisition which includes an initial investment of $35M and upfront closing payment of $200M, regulatory achievement milestones of up to $125M and commercial milestones of up to $775M through 2029 for a total consideration of up to $1.135 […]

thaipr.net

20 ต.ค. 65

U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted as a Booster for Adults

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide a first booster dose at least six months after completion of primary vaccination […]

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20 ต.ค. 65
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