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The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which identifies patients with HR–positive, HER2-ultralow metastatic breast cancer who may be eligible for treatment with Enhertu.

President Trump’s tariffs will include imported pharmaceuticals, among other items that will impact the industry.

Dr. Shakthi Kumar, EDETEK, Inc.'s Chief Strategy and Business Officer, discusses future plans for R&D Cloud.

Daniel Vitt, CEO, Immunic Therapeutics, discusses promising results from the Phase Ib trial of IMU-856 in celiac disease.

Clinical trials demonstrated that a single dose of Symbravo provides rapid migraine relief, sustains efficacy for up to 48 hours, and reduces the need for rescue medication.

Approval of Journavx for acute pain marks the first new class of acute pain medication approved by the FDA in over 20 years.

A Harvard Business School Healthcare Alumni Association Q&A with Paul Ollinger, one of Facebook’s first 250 employees.

Senators Durbin and Grassley proposed the new regulations for direct-to-consumer pharma advertising.

The latest news for pharma industry insiders.

Dr. Shakthi Kumar, EDETEK, Inc.'s Chief Strategy and Business Officer, explores the company's launch of R&D Cloud.

Q4 earnings for companies such as Johnson & Johnson, Teva, and Roche highlight the impact of significant innovations brought to market last year.

The Phase III trial builds on findings from prior findings that indicated Anktiva can restore T-cell function and improve overall survival in patients with advanced of metastatic non-small cell lung cancer who are PD-1 checkpoint inhibitor resistant.

The two organizations will provide multi-modal learning experiences, opportunities to work with peers, and more.

Gregory Mattingly, MD, president, Midwest Research Group, founding partner, St. Charles Psychiatric Associates, discusses the immediate impact Spravato has had on patients with treatment-resistant depression.

The two companies will combine existing assets in order to find new connections and opportunities.

The new app provides user with more features, including an AI-powered search, than the pharmacy’s previous app.

Nancy Ghattas, VP, US franchise head, imunno-oncology, gastrointestinal tumors, AstraZeneca, discusses the promising results from the ADRIATIC trial, in which patients were treated with Imfinzi for limited-stage small cell lung cancer.

Effective February 10, 2025, Mamilli will assume global responsibility for the Informatics function for the Roche Group.

The new Medicare alternative payment model aims to improve dementia care coordination.

Approval was based on results from the Phase IIIb FLOW trial, which demonstrated a 24% relative risk reduction in kidney disease, kidney failure, and cardiovascular death in patients treated with Ozempic.

Prescription data between 2017 and 2023 revealed that while Adderall prescription fills decreased following the shortage, many children transitioned to alternative stimulants for attention-deficit/hyperactivity disorder.

Gregory Mattingly, MD, president, Midwest Research Group, founding partner, St. Charles Psychiatric Associates, discusses the approval of Spravato for treatment-resistant depression.

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.

The health-tech company is teaming up with Vitable and MARPAI on the project.

The deal allows for sugemalimab to be commercialized across 10 Latin America countries.

The government agency says X no longer suits its communication needs.

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.