Don Tracy, Associate Editor

Partnership is expected to leverage Amneal’s global manufacturing and product development experience and Metsera’s portfolio of ultra-long acting injectables and oral nutrient-stimulated hormone analogs.

The application for Priority Review of Enhertu was supported by positive results from the DESTINY-Breast06 Phase III trial, which demonstrated that Enhertu reduced the risk of disease progression or death by 37% in patients with HER2-low or HER2-ultralow metastatic breast cancer.

Flyrcado is the first positron emission tomography myocardial perfusion imaging agent of its kind designed for the detection of coronary artery disease.

Designed for cataract patients, the TECNIS Odyssey aims to reduce the need for glasses by offering a full range of precise vision at all distances.

Dupixent was found to significantly reduce the rate of moderate to severe exacerbations of chronic obstructive pulmonary disease, according to data from the Phase III BOREAS and NOTUS trials.

Landmark FDA approval of Cobenfy represents the first new class of drugs indicated to treat schizophrenia in decades.

A new JAMA study indicates that semaglutide produced up to a 68% lower risk of opioid overdose for patients with type 2 diabetes compared to other antidiabetic medications.

Tagrisso was approved under a Priority Review based on the pivotal LAURA Phase III trial in adults with unresectable stage III epidermal growth factor receptor-mutated non-small cell lung cancer.

Rybrevant is the first targeted second-line regimen to significantly reduce the risk of disease progression by more than 50% in patients with locally advanced or metastatic EGFR mutated non-small cell lung cancer, according to Johnson & Johnson.

Results of the Phase III HERTHENA-Lung02 trial demonstrated the superiority of patritumab deruxtecan over platinum plus pemetrexed induction chemotherapy in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer.

Approval was based on results from the MANDARA Phase III trial, which demonstrated the superiority of Fansenra over Nucala in patients with eosinophilic granulomatosis with polyangiitis.

Approval was based on data from the IND.227/KEYNOTE-483 trial, which demonstrated a 21% reduction in the risk of death when Keytruda was added to chemotherapy in patients with unresectable advanced or metastatic malignant pleural mesothelioma.

Ten-year data from the Phase III KEYNOTE-006 trial found that Keytruda produced a 34% ten-year overall survival rate compared to 23.6% for ipilimumab in patients with advanced melanoma.

Results from the Phase II PHAROS trial found that treatment-naïve patients with BRAF V600E-mutant metastatic non-small cell lung cancer administered Braftovi in combination with Mektovi achieved an objective response rate of 75%.

As chief medical officer, Foley is expected to guide the clinical direction of True Digital Surgery and the advancement of its Digital Surgical Exoscope Platform.

Results from the ADvocate 1, ADvocate 2, and ADhere clinical trials found that patients treated with Ebglyss 38% of patients with moderate-to-severe atopic dermatitis achieved clear or almost-clear skin after 16 weeks of treatment.

Ocrevus Zunovo is the first and only twice-yearly, 10-minute subcutaneous injection for treating both relapsing multiple sclerosis and primary-progressive multiple sclerosis.

Landmark results from the Phase III PURPOSE 2 trial found that lenacapavir demonstrated 89% greater efficacy than Truvada in preventing HIV infections.

Subcutaneous Tecentriq Hybreza will provide patients and physicians increased flexibility for administration of the immunotherapy across approved indications for Tecentriq, including non–small cell lung cancer, small cell lung cancer, and hepatocellular carcinoma.

Dupixent displayed a nearly 50% reduction in itch and urticaria activity scores in patients with chronic spontaneous urticaria.

Tremfya is the first and only fully-human, dual-acting monoclonal antibody targeting IL-23 and CD64 to be approved for the treatment of moderately to severely active ulcerative colitis.

A recent study by Morningstar predicts that 16 new weight-loss drugs could be on the market by 2029.

Results from the Phase Ib Beamion LUNG-1 trial found that zongertinib achieved an objective response rate of 66.7% in previously treated patients with advanced non-small cell lung cancer with HER2 mutations.

Filspari is considered the first non-immunosuppressive treatment to significantly slow kidney function decline in adults with IgA nephropathy.

Results of the FENopta study found that after one year of treatment, 96% of patients experienced no relapses of multiple sclerosis, with an annualized relapse rate of just 0.04.

Results from the MATINEE trial found that Nucala led to a statistically significant and clinically meaningful reduction in moderate/severe exacerbations of chronic obstructive pulmonary disease compared to placebo over 104 weeks.

Boruzu is the first ready-to-use version of bortezomib for subcutaneous and intravenous administration in the treatment of multiple myeloma and mantle cell lymphoma.

Results from the QWINT-1 and QWINT-3 trials found that insulin-naïve patients achieved similar reductions in A1C levels using once-weekly efsitora compared to daily insulin glargine and degludec.

Data from the Phase II/III DEVOTE study demonstrated that Spinraza showed significant motor function improvements at six months in infants with spinal muscular atrophy.

Results from the FINE-HEART pooled analysis of three Phase III clinical trials highlighted the potential of finerenone in treating high-risk cardiovascular patients.