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 AD04-13 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.

A new offering in collaboration with Progyny, Inc makes fertility/family-building services more accessible and equitable.

Physicians remain central even as DTP programs are implemented.

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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.

The technology is part of a larger platform that provides a variety of AI-powered services.

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The company revealed plans to increase the usage of AI in pharma at JP Morgan’s healthcare conference in San Francisco.

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.

Moderna provided updates on key elements of its pipeline, including a next-generation COVID-19 vaccine, an RSV vaccine, a new seasonal flu, and a combination seasonal flu/COVID vaccine.

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

The association also named Jim Weiss as honorable mentor and Rebecca Vermeulen as its STAR recipient.

The new digital ecosystem offers scalable and flexible environment for clinical development.

The company provided information about its upcoming oncology portfolio, along with developments from its MoDE platform.

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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.

The Swiss company is focused on developing treatments for respiratory conditions, such as asthma and COPD.

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Company leadership urged members and employees to stay safe and follow evacuation orders.