Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTCQX: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, today announced the submission of a Premarket Approval ...
Dordaviprone addresses a significant unmet patient need for patients with rare, high-grade brain tumors- -Transaction to add near-term commercial opportunity to Jazz's pipeline- -Transaction ...
Trump says the increase of the tariffs is a response to the price increases that the provincial government of Ontario put on ...
Sigrid Therapeutics (Sigrid) is excited to announce that it has secured U.S. market access for its proprietary SiPore� technology, following the success of the SHINE study, the largest of its kind in ...
Topline clinical data of the confirmatory registrational study GLOW2 expected in 1Q 2026. GLOW2 study design mirrors GLOW1 study, which met primary endpoint and all key secondary ...
Accelerated fourth quarter sales growth to 13.5%Fourth quarter gross margin expanded 310 bps and adjusted gross margin* expanded 230 bpsFourth quarter cash from operations of $19.3 million increased ...
Topline clinical data of the confirmatory registrational study GLOW2 expected in 1Q 2026. GLOW2 study design mirrors GLOW1 study, which met primary endpoint and ...
One FDA employee described the situation as a “Hunger Games-type situation” in which workers encountered overflowing ...
WASHINGTON (AP) — Thousands of employees returned to the Food and Drug Administration’s headquarters Monday to find ...
Seek to clarify that certain hearing implants are prosthetics and therefore not subject to the hearing aid coverage exclusion, allowing for ...
Dr. Marty Makary — a surgeon, author and researcher — lauded the FDA’s “gold-standard science” in testimony before the Senate’s health committee, which will vote on whether to advance ...
The company has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) — a critical regulatory step. This product is now ready to be converted into a finished drug product.