Health

Pharming Announces European Medicines Agency (EMA) Validates its Marketing Authorisation Application under Accelerated Assessment for leniolisib

Marketing authorisation in the European Economic Area anticipated in H1 2023 Pharming Group N.V. (“Pharming” or “the Company”) (EURONEXT Amsterdam: PHARM / Nasdaq: PHAR) announces today that its Marketing Authorisation Application (MAA) for leniolisib has been validated for scientific evaluation under an accelerated assessment by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human…

thaipr.net

31 ต.ค. 65

Samyang Holdings’ Lafullen Makes Splash in Korean Medical Aesthetics Market

– Successfully demonstrated Lafullen’s safety and efficacy at autumn medical symposiums – Shared treatment protocols and clinical cases to lecturers by specialist – Continued to develop evidence-based marketing to Asian markets Samyang Holdings Biopharmaceuticals Division (CEO: Lee Young-Joon) participated in recent autumn medical symposiums in Korea to raise awareness of Lafullen, an injectable dermal filler. […]

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31 ต.ค. 65

Cambrex to Invest $16.5 Million in New R&D Facility in Minneapolis, Minnesota and Expansion in Charles City, Iowa

Cambrex today announced it is investing in a new, 21,000-square-foot research and development facility in Minneapolis, Minnesota, expanding its capacity for small molecule development and manufacturing. Strategically located near the Minneapolis–St. Paul Airport, the new facility will specialize in analytical and chemical development for pharmaceutical drug candidates and will operate as an extension of Cambrex’s […]

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28 ต.ค. 65

Texas Cardiac Arrhythmia Institute physician led international workshop on cardiac arrhythmias

The executive medical director of the Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center recently led Venice Arrhythmias 2022, a biennial international workshop on cardiac arrhythmias held in Venice, Italy from October 13 to October 15, 2022. As Venice Arrhythmias president, Andrea Natale, M.D., F.A.C.C., F.H.R.S., F.E.S.C., organized the programming for the event. More than 600 attendees from […]

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27 ต.ค. 65

MedAlliance SELUTION SLR Receives Coronary FDA IDE Approval

Following our communication last  week “MedAlliance to be acquired by Cordis”, MedAlliance is pleased to make the following announcement:  SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, has received FDA Investigational Device Exemption (IDE) approval to initiate its coronary pivotal clinical trial.  This is the first sustained limus release coronary drug eluting balloon (DEB) to receive FDA IDE approval…

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26 ต.ค. 65

SIRONA completes enrollment – A leap in the DCB treatment of femoropopliteal arterial disease

Concept Medical Inc. announces the successful completion of the SIRONA – World’s first and the largest head-to-head RCT investigating the use of Sirolimus Drug Coated Balloon (DCB) (Magic Touch PTA – Concept Medical Inc.) V/S Paclitaxel DCB angioplasty for the treatment of peripheral artery disease in the femoropopliteal vessel segment. The prospective, multi-center, head-to-head, corelab adjudicated RCT […]

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25 ต.ค. 65

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 […]

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25 ต.ค. 65
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