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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
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Ultragenyx setrusumab misses primary endpoints in Phase 3 osteogenesis imperfecta trials

Ultragenyx Pharmaceutical (NASDAQ:RARE) Phase 3 trials of setrusumab (UX143) in osteogenesis imperfecta failed to meet their primary endpoints, prompting the company to plan significant expense reductions while it evaluates next steps for the program.

Leia mais: Ultragenyx setrusumab misses primary endpoints in Phase 3 osteogenesis imperfecta trials