BioSpace News Archive

Certara, Inc., a global leader in biosimulation, announced it has successfully supported 300 completed submissions to regulatory agencies worldwide.

ReCode Therapeutics today announced the closing of an extension to its Series B financing.

Medidata, a Dassault Systèmes company, today announced the launch of the Medidata Diversity Program, the industry’s most comprehensive solution for improving diversity, equity, and inclusion in clinical trials.

Avilar Therapeutics today announced that its company leaders will participate in two upcoming industry conferences, highlighting the company’s proprietary protein degradation platform capabilities and associated opportunities to target historically intractable pathogenic proteins.

Natural Cycles, the company that developed the world’s first birth control app, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its use of wrist temperature data from Apple Watch.

SpectraWAVE, Inc today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for product enhancements to the HyperVue™ Imaging System.

Cerevance, today announced that the first subject has been dosed in the Phase 1 clinical study evaluating the safety, tolerability, and pharmacokinetics of CVN293.

Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT) today announced the results of a phase 1/2 study showing that a booster dose of a novel, self-amplifying messenger RNA (sa-mRNA) vaccine against COVID-19 induces a robust, broadly cross-reactive, and durable immune response in adults that remains elevated through 12 months after vaccination.

Sonnet BioTherapeutics Holdings, Inc., announced today that it has received formal notice from the Listing Qualifications staff of The Nasdaq Stock Market indicating that Sonnet has regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2).

JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced that data from the ALIGN-AR Pivotal Trial will be presented by Dr. Vinod Thourani (Piedmont Heart Institute, Atlanta, GA) during the Late-Breaking Clinical Trial sessions at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) Annual Scientific Symposium in San Francisco, CA.