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As part of the Fast Track designation, Sanofi is set to launch a Phase I/II trial to evaluate the immunogenicity and safety of its novel mRNA vaccine in preventing chlamydia.

Approval of Vykat XR marks the first treatment indicated for hyperphagia in patients with Prader-Willi syndrome.

The Healthwell Foundation published research that questioned over 1,500 Americans about their healthcare status.

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The new product will allow for improved mRNA production with reduced costs.

Results from multiple clinical trials showed that Tagrisso demonstrated survival benefits in EGFR-mutated non-small cell lung cancer, both as monotherapy and in combination therapies.

Blujepa marks the first new oral antibiotic to gain FDA approval for uncomplicated urinary tract infections in nearly 30 years.

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Under terms of the deal, Merck will gain global rights to develop, manufacture, and commercialize HRS-5346 for cardiovascular disease, excluding Greater China.

Under terms of the license agreement, Novo Nordisk will acquire the rights to develop and commercialize UBT251 outside of China for obesity and type 2 diabetes for an upfront payment of $200 million.

The potential vaccine is being developed in partnership with the Cleveland Clinic and the NCI.

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The facility, which is set to open amid Biogen’s 50th anniversary, will integrate research and development, technical operations, and commercial teams into one location.

Fanhalta marks the first and only treatment for C3 glomerulopathy to gain FDA approval.

The biotech won the award for its work in obesity and inflammation treatment.

Research also showed that the test has a very low false positive rate.

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Tremfya is the first and only IL-23 inhibitor with both subcutaneous and intravenous induction options for adults with moderately to severely active Crohn disease in the United States.

The investment, which is a 25% increase from previous years, will support three new advanced manufacturing facilities, expansions at existing sites, and R&D efforts.

Results from the STEER and STRENGTH studies showed that OAV101 IT led to a 2.39-point improvement in motor function in patients with spinal muscular atrophy.

The pharmaceutical company had previously been subjected to a 2-year suspension.

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HCSC will take ownership of multiple businesses, allowing Cigna to refocus its efforts.

DR-0201, a CD20-directed bispecific antibody, has demonstrated robust B-cell depletion in early clinical studies, showing promise in treating refractory B-cell-mediated autoimmune diseases.

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In the Phase III STOP-HS1 and STOP-HS2 trials, results show that patients treated with povorcitinib for hidradenitis suppurativa experienced a ≥50% reduction in the total abscess and inflammatory nodule count.

Latigo Biotherapeutics, Vivace Therapeutics, and Vori Health each announced the recent successful closing of their respective financing rounds.

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In the Phase III CALYPSO trial, eneboparatide demonstrated statistical significance in achieving albumin-adjusted serum calcium normalization while eliminating the need for active vitamin D and oral calcium therapy in chronic hypoparathyroidism.