Perimeter Files FDA PMA Application for its Next-Generation B-Series OCT with ImgAssist AI 2.0
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 ...
House passes bill to fund federal agencies through September, sending it to the Senate. Here’s how it unfolded.
Trump says the increase of the tariffs is a response to the price increases that the provincial government of Ontario put on ...
The Manila Times5d
Anika Reports Fourth Quarter and Full Year 2024 Financial Results
Anika announced fourth quarter revenue from continuing operations of $30.6 million increasing 1% compared to the same period ...
Bioventus, Inc.: Bioventus Announces Fourth Quarter and Full Year 2024 Financial Results
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 ...
Kodiak Sciences Inc.: Kodiak Sciences Completes Enrollment in Second Registrational Trial of Tarcocimab in Patients with Diabetic Retinopathy
Topline clinical data of the confirmatory registrational study GLOW2 expected in 1Q 2026. GLOW2 study design mirrors GLOW1 study, which met primary endpoint and ...
FDA return-to-work mandate results in ‘absolute chaos’
One FDA employee described the situation as a “Hunger Games-type situation” in which workers encountered overflowing ...
FDA staff return to crowded offices, broken equipment and missing chairs
WASHINGTON (AP) — Thousands of employees returned to the Food and Drug Administration’s headquarters Monday to find ...
Hearing Device Coverage Clarification Act Reintroduced in House and Senate
Seek to clarify that certain hearing implants are prosthetics and therefore not subject to the hearing aid coverage exclusion, allowing for ...
Phlow Corp. Achieves Key Milestone Toward Full Epinephrine Production — Made in America
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.
Cellphire Therapeutics CLPH-511 Fast Track Designation Granted
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 ...
Pliant Therapeutics Announces Interim Phase 1 Data for PLN-101095 in Patients with Immune Checkpoint Inhibitor-Refractory Advanced Solid Tumors
Antitumor activity observed with confirmed partial responses in 50% of patientsat highest dose tested to date, across ...
Food Safety News4d
Senate committee advances Makary to become new head of the FDA
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 ...