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ARS Pharma Wins China Approval for Nasal Epinephrine, Secures Milestone Payment

ARS Pharmaceuticals (NASDAQ:SPRY) said China’s drug regulator has approved neffy 2 mg, an epinephrine nasal spray, for the emergency treatment of Type 1 allergic reactions in adults and children weighing at least 30 kilograms, marking the first epinephrine product authorized for community use in the country.

Leia mais: ARS Pharma Wins China Approval for Nasal Epinephrine, Secures Milestone Payment
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Tonix outlines late-stage development path for long-acting Lyme disease antibody

Tonix Pharmaceuticals (NASDAQ:TNXP) said it is advancing development plans for TNX-4800, a long-acting human monoclonal antibody designed for the prevention of seasonal Lyme disease, as the company prepares for regulatory discussions on potential late-stage clinical pathways.

Leia mais: Tonix outlines late-stage development path for long-acting Lyme disease antibody
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GATX, Brookfield win regulatory clearance for $4.4B Wells Fargo railcar deal

GATX Corp. (NYSE:GATX) said it and Brookfield Infrastructure Partners L.P. (NYSE:BIP) have received all required regulatory approvals to complete their previously announced transaction to acquire Wells Fargo’s rail operating lease portfolio

Leia mais: GATX, Brookfield win regulatory clearance for $4.4B Wells Fargo railcar deal
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Praxis wins FDA breakthrough designation for essential tremor drug

Praxis Precision Medicines (NASDAQ:PRAX) said the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to ulixacaltamide, a selective T-type calcium channel inhibitor being developed for the treatment of essential tremor, accelerating the regulatory path for the experimental therapy.

Leia mais: Praxis wins FDA breakthrough designation for essential tremor drug
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Mereo BioPharma’s setrusumab misses primary endpoints in Phase 3 bone disease trials

Mereo BioPharma (NASDAQ:MREO)  said Phase 3 trials of setrusumab (UX143) in osteogenesis imperfecta failed to meet their primary endpoints, dealing a setback to the late-stage program as the company moves to cut spending and reassess priorities.

Leia mais: Mereo BioPharma’s setrusumab misses primary endpoints in Phase 3 bone disease trials