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 ...
Anika announced fourth quarter revenue from continuing operations of $30.6 million increasing 1% compared to the same period ...
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 ...
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.
The use of CLPH-511 in acute hemorrhage is currently being investigated in a Phase 2/3 adaptive design study, titled “Randomized Controlled Trial Comparing Dimethyl Sulfoxide Cryopreserved Platelets ...
Antitumor activity observed with confirmed partial responses in 50% of patientsat highest dose tested to date, across ...
Marty Makary is one step closer to becoming the head of the Food and Drug Administration. On March 13, the Senate Health, Education, Labor and Pensions Committee voted to advance Makary’s ...
The government's free at-home COVID-19 test distribution program is no longer accepting orders, its website says. Here's how to get tests in the meantime.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman M.D ...