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 ...
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 ...
Orphan Drug Designation follows positive Phase 1 data presented at the 12th International Workshop on Waldenström MacroglobulinemiaFirst-in-class ...
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News-Medical.Net on MSNClinical trial of vaccine candidate to prevent Lassa fever begins enrollmentA (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.
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