La FDA accorde la Breakthrough Device Designation au système μFR® de Pulse Medical

SHANGHAI, 29 mai 2023 /PRNewswire/ — Le système μFR® de 4e génération de Pulse Medical Technology, Inc. (Pulse Medical) a reçu la désignation de dispositif révolutionnaire (Breakthrough Device) de la FDA. Pulse Medical, fondée en 2015 et située à Shanghai, en Chine, se consacre au développement d’une technologie innovante pour un diagnostic précis et un traitement optimal des patients atteints … Read more

Pulse Medical recibe la designación de dispositivo innovador de la FDA para su sistema μFR®

SHANGHAI, 29 de mayo de 2023 /PRNewswire/ — El sistema μFR® de cuarta generación de Pulse Medical Technology, Inc. (Pulse Medical) ha recibido la designación de dispositivo innovador de la FDA. Pulse Medical, fundada en 2015, ubicada en Shanghái, China, se dedica a desarrollar tecnología innovadora para el diagnóstico preciso y el tratamiento óptimo de pacientes … Read more

Nuvaxovid™ von Novavax erhält positive CHMP-Stellungnahme für vollständige Marktzulassung zur Prävention von COVID in der EU

GAITHERSBURG, Maryland, 27. Mai 2023 /PRNewswire/ — Novavax, Inc. Nasdaq: NVAX), ein globales Unternehmen, das Impfstoffe auf Proteinbasis mit seinem neuartigen Matrix-M™-Adjuvans entwickelt, gab heute bekannt, dass Nuvaxovid™ (NVX-CoV2373) in der Europäischen Union (EU) nach einer positiven Stellungnahme der European Medicines Agency für Medicinal Products for Human Use (CHMP) zur vollständigen Zulassung als Erstimpfung bei Personen … Read more

Pulse Medical erhält FDA-Zulassung als bahnbrechendes Gerät für sein μFR®-System

SHANGHAI, 26. Mai 2023 /PRNewswire/ — Das μFR®-System der vierten Generation von Pulse Medical Technology, Inc. (Pulse Medical) hat von der FDA den Status eines bahnbrechenden Geräts erhalten.  Pulse Medical wurde in 2015 gegründet und hat seinen Sitz in Shanghai, China, und widmet sich der Entwicklung innovativer Technologie für eine präzise Diagnose und optimale Behandlung … Read more

BIOLASE Inc. Announces Closing of $4.5 Million Underwritten Public Offering of Series H Convertible Redeemable Preferred Stock and Warrants

LAKE FOREST, Calif., May 26, 2023 /PRNewswire/ — BIOLASE, Inc. (NASDAQ: BIOL) (“BIOLASE” or the “Company”), a global leader in dental lasers, today announced the closing of its previously announced underwritten public offering of 175,000 units (the “Units”), with each Unit consisting of one share of BIOLASE’s Series H Convertible Redeemable Preferred Stock, par value $0.001 per … Read more

Terran Biosciences announces new breakthroughs in the chemistry of MDMA and its enantiomers and analogs, discovers new salts and polymorphs, publishes PCT application.

New York, May 26, 2023 /PRNewswire/ — Terran Biosciences (“Terran”), a biotech platform company dedicated to the development of transformational therapeutics for neurological and psychiatric diseases, has announced the publication of a PCT patent application covering what may be the first comprehensive salt and polymorph screens of the empathogens MDMA, (R)-MDMA, (S)-MDMA, MDEA (MDE), (S)-MDEA, (R)-MDEA, … Read more

IDEAYA Biosciences Announces Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

SOUTH SAN FRANCISCO, Calif., May 26, 2023 /PRNewswire/ — IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that, on May 25, 2023, the Compensation Committee of IDEAYA’s Board of Directors granted non-qualified stock options to purchase an aggregate of 17,800 shares of … Read more

Leap Therapeutics to Present Updated Data from Part A of the DisTinGuish Study of DKN-01 Plus Tislelizumab and Chemotherapy in Gastric Cancer Patients at the 2023 ASCO Annual Meeting

19.5 months median OS in the overall first-line patient population, exceeding current benchmarks Long-term follow-up identifies additional patient with partial response, resulting in 73% ORR in overall mITT population, including 86% ORR in PD-L1-low patients CAMBRIDGE, Mass., May 25, 2023 /PRNewswire/ — Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology … Read more

Sera Prognostics Announces Commercial Changes and Actions to Optimize Business for Market Success Toward Accelerating Test Adoption and Revenue

Aligning Management Team given New Refined Commercial Focus on Institutions Starting with Recent Appointment of Board Member Zhenya Lindgardt as Interim President and CEO Engages Leading Strategy House to Evaluate Best Pathways Toward Targeting Enhanced Revenue Generation at Significantly Reduced Operating Costs Nadia Altomare Expected to Move from Chief Commercial Officer to Consulting Role to … Read more

Hememics Biotechnologies, Inc. Announces Successful Close in $2 Million Seed 2 Financing from TEDCO and Qualified Investors to Accelerate Growth

GAITHERSBURG, Md., May 25, 2023 /PRNewswire/ — Hememics Biotechnologies, Inc., developer of first-in-class, handheld, multiplexed biosensor platform that can test antibodies, antigens and molecular targets simultaneously, announced today the closing of a $2 million Seed 2 financing round. Participants of this round include a strategic investor, existing investors and Maryland Technology Development Corporation (TEDCO). “I … Read more