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 ...
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 ...
Nurix Announces U.S. FDA Orphan Drug Designation Granted to Bexobrutideg (NX-5948) for the Treatment of Waldenström Macroglobulinemia
Orphan Drug Designation follows positive Phase 1 data presented at the 12th International Workshop on Waldenström MacroglobulinemiaFirst-in-class ...
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Clinical trial of vaccine candidate to prevent Lassa fever begins enrollment
A (NIH)-sponsored clinical trial of a candidate vaccine to prevent Lassa fever has begun enrolling participants at the University of Maryland School of Medicine, Baltimore.