The U.S. FDA has made clear its expectations of batteries and accessories for automated external defibrillators, but at least one maker of replacement AED batteries seems to have not got the message.
Insignis Therapeutics Inc.’s sublingual anaphylaxis treatment IN-001 has received Fast Track designation from the FDA. The Fast Track program is designed to expedite the product review and facilitate the development of drugs that treat serious conditions and address unmet medical needs.
Medigene AG has provided a pipeline update in its half-year report for the first half of 2024. The company, which develops T cell receptor (TCR)-guided therapies for the treatment of cancer, confirmed for following positive EU and U.S. preliminary regulatory interactions, is on track for filing an IND in Q3 and a CTA in Q4 of 2024 for its lead candidate MDG-1015.
Cidara Therapeutics Inc. announced in its Q2 filing that it received IND clearance for its drug-Fc conjugate (DFC) immunotherapy CBO-421 in July of 2024.
Aiming to offer an advantage over Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), dermatology-focused Galderma Holding SA won clearance from the U.S. FDA for Nemluvio (nemolizumab) as a prefilled pen providing a subcutaneous injection to treat adults with prurigo nodularis (PN).
Neuren Pharmaceuticals Ltd.’s NNZ-2591 met the primary endpoints in a phase II trial in children with Angelman syndrome, with improvements seen in clinically important aspects of the disease, including communication, behavior, cognition and motor abilities, Neuren CEO Jon Pilcher said during an Aug. 9 conference call.
The U.S. FDA warning letter to Globus Medical Inc., highlights some long-running concerns at the agency about medical device reporting practices, but the agency was keen to point to a problem with the company’s complaint trending practices.
Executives of ARS Pharmaceuticals Inc. are anticipating a quick switch for severe allergy patients following the U.S. FDA approval of Neffy (epinephrine nasal spray 2 mg), marking the first needle-free treatment option.
After many months of jockeying, the U.S. FDA has approved Ascendis Pharma A/S’ hormone replacement therapy Yorvipath (palopegteriparatide) for treating hypoparathyroidism. Ascendis said this is the first and only treatment for adults with the rare endocrine disease.
The U.S. FDA draft guidance for enforcement of in vitro diagnostics for emergent threats without a public health emergency has proposed some significant restrictions, which drew several negative responses.
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