Sat.Mar 23, 2024 - Fri.Mar 29, 2024

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FDA approves J&J’s OPSYNVI for pulmonary arterial hypertension

Pharmaceutical Technology

The US FDA approved Johnson & Johnson's (J&J) OPSYNVI for chronic treatment in adult patients with pulmonary arterial hypertension.

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AstraZeneca Gains FDA Nod for Ultomiris, a Treatment for Managing NMOSD

PharmaTech

FDA has approved AstraZeneca's Ultomiris, marking the first and only long-acting C5 complement inhibitor for patients with NMOSD.

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FDA Hands Expanded Indication to Gilead’s Vemlidy for Chronic HBV Infection in Pediatric Patients

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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FDA Grants Pemivibart Emergency Use Authorization for PrEP of COVID-19 in Immunocompromised Patients

Pharmacy Times

The indication is for adults and adolescents with moderate to severe immune compromise due to medical conditions or immunosuppressive medications and treatments.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

A recent draft from the FDA provides valuable insight. Learning Objectives: Dose-response curves and patient treatment: How do pharmacologic and toxicologic principles apply to the dosing of drugs in clinical development? What will the future hold for clinical research?

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First-in-class biologic approved for rare lung disease

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved WINREVAIR ( sotatercept -csrk) for subcutaneous injection (45mg, 60mg) for adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1). Further findings from the Phase III trial The FDA approval is based on results from the Phase III STELLAR trial.

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FDA Approves AstraZeneca’s Ultomiris for Neuromyelitis Optica Spectrum Disorder

PharmExec

Action marks the first FDA approval of a long-acting treatment for adult patients with neuromyelitis optica spectrum disorder who are positive for the anti-aquaporin-4 antibody.

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