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 ...
Jazz Pharmaceuticals plc: Jazz Pharmaceuticals to Acquire Chimerix, Further Diversifying Oncology Portfolio
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 ...
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 ...
Medindia7d
Sigrid Therapeutics Secures U.S. Market Access for SiPore Technology Following SHINE Prediabetes Study Success
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 ...
Medindia7d
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 all key secondary ...
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 ...
Newsday11d
FDA nominee sidesteps questions on abortion pill, agency layoffs and other issues
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 ...
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.