Don Tracy, Associate Editor

Approval of Enhertu marks the first HER2-directed therapy indicated for adults with unresectable or metastatic HR-positive, HER2-low, or HER2-ultralow metastatic breast cancer.

Priority review for Welireg is based on data from the Phase II LITESPARK-015 trial, which showed promising response rates in patients with advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.

Approval was based on results from multiple studies, which demonstrated a slowing of cognitive decline in patients with Alzheimer disease administered Leqembi.

Application is supported by results from the DEVOTE study, which suggested that two doses of Spinraza (nusinerse) 50 mg taken 14 days apart can deliver significant clinical benefits in patients with spinal muscular atrophy.

Under terms of the deal, AbbVie will provide Neomorph with an upfront payment and the potential to earn up to $1.64 billion in milestone payments.

Trial findings show long-term recurrence-free survival in patients with low-grade upper tract urothelial cancer treated with Jelmyto.

As part of the regulatory action, memantine/donepezil extended-release capsules have been granted a 180-day exclusivity in patients with Alzheimer disease, with Everolimus receiving approval for tuberous sclerosis complex.

The trial, developed in collaboration with Novotech, will specifically target dietary and alcohol-induced overindulgence.

The cobas liat test aims to improve patient outcomes by offering rapid, accurate results in decentralized and community-based settings for patients at risk for chlamydia, gonorrhea, and Mycoplasma genitalium.

Cary Claiborne, CEO, Adial Pharmaceuticals, discusses AD04’s development timeline and next steps towards approval for alcohol use disorder.

Data from a Phase Ia single ascending dose study found that ASC30 demonstrated dose-proportional pharmacokinetics, a half-life of up to 60 hours, and superior pharmacokinetic properties compared to other oral GLP-1 receptor agonists.

Spravato is the first and only monotherapy to gain FDA approval for treatment-resistant depression.

Approval is based on results from the TROPION-Breast01 Phase III trial, in which Datroway demonstrated a significant reduction in the risk of disease progression or death in patients with previously treated, unresectable, or metastatic HR-positive, HER2-negative breast cancer.

Approval is based on data from the Phase III CodeBreaK 300 trial, which demonstrated that treatment with Lumakras and Vectibix significantly improved progression-free survival in patients with KRAS G12C-mutated metastatic colorectal cancer.

Approval follows results from the Phase III ECHO trial, which demonstrated that Calquence plus chemotherapy reduced the risk of disease progression or death by 27% in patients with previously untreated mantle cell lymphoma.

As part of the Inflation Reduction Act, price negotiations with manufacturers will begin this year, with reduced prices expected to take effect in 2027.

Niktimvo marks the first FDA-approved therapy targeting CSF-1R to address inflammation and fibrosis in chronic graft-versus-host disease.

Cary Claiborne, CEO, Adial Pharmaceuticals, discusses promising results of the AD04 study in patients with Alcohol Use Disorder

Approval was based on results of the VIVID-1 study, which found that Omvoh demonstrated significant clinical remission and endoscopic response rates in patients with Crohn disease.

The New Drug Application for TAR-200 is supported by results from the Phase IIb SunRISe-1 study, which demonstrated an 83.5% complete response in patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer.

During the transition period, Lykos will work with a number of shareholders to secure financing for an additional Phase III trial of midomafetamine capsules for post-traumatic stress disorder.

John Hood, CEO, Endeavor BioMedicines discusses partnering with advocacy groups to increase awareness of clinical trials for idiopathic pulmonary fibrosis.

Acceptance of the Biologics License Application for subcutaneous Leqembi is based on results from the Clarity AD open-label extension and modeling of observed data in patients with Alzheimer disease.

New partnerships aim to expand Teva’s biosimilar portfolio and enhance access to high-cost biologics across key markets.

Organizations including Gilead, Eli Lilly, and AbbVie announced a number of deals addressing inflammatory diseases, multiple myeloma, and other disease areas.

Under terms of the deal, GSK will also acquire IDRX-42, a tyrosine kinase inhibitor designed to treat both primary and secondary KIT mutations in patients with gastrointestinal stromal tumors.

Acquisition includes Caplyta, a once-daily oral therapy approved for schizophrenia and bipolar depression.

San Francisco Police cancel time off requests to increase security at the J.P. Morgan Healthcare Conference after the recent murder of UnitedHealth Group CEO Brian Thompson.

Priority Review was based on results from the Phase III Vivacity-MG3 study of nipocalimab in patients with generalized myasthenia gravis.

Abrysvo and Arexvy will now be required to come with labeling that includes a warning about a potential increased risk of Guillain-Barré Syndrome.