April 21st 2025
The simplified requirements for Camzyos are expected to ease prior contraindications, thereby simplifying treatment and expanding eligibility in patients with symptomatic New York Heart Association Class II-III obstructive hypertrophic cardiomyopathy.
How Uncertainty & Distrust Damage Relationships with Patients
February 11th 2025In this Pharmaceutical Executive video interview, Ian Baer, Founder & CEO of Sooth, identifies how uncertainty of where to find information, coupled with distrust, can damage the relationship between pharmaceutical companies and the patients they aim to serve.
FDA Approves Supernus Pharmaceuticals’ Onapgo for Managing Motor Fluctuations in Parkinson Disease
February 7th 2025Approval of Onapgo (apomorphine hydrochloride) marks the first and only subcutaneous apomorphine infusion device for managing motor fluctuations in adults with advanced Parkinson disease.
FDA Approves Roche’s Susvimo Refillable Eye Implant for Diabetic Macular Edema
February 4th 2025Roche’s Susvimo, a refillable eye implant for diabetic macular edema, provides continuous delivery of ranibizumab, showing sustained vision improvements with fewer treatments than standard eye injections.
Spravato’s Transformative Impact: Offering Hope and Rapid Relief for Patients with Depression
January 30th 2025Gregory 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.
Biogen Seeks FDA Approval for a Higher Dosing Regimen of Spinraza for Spinal Muscular Atrophy
January 24th 2025Application 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.
FDA Grants 510(k) Clearance to Roche’s Cobas Liat Molecular Test for Sexually Transmitted Infections
January 22nd 2025The 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.
FDA Approves Amgen’s Lumakras Plus Vectibix for KRAS G12C-Mutated Metastatic Colorectal Cancer
January 20th 2025Approval 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.
FDA Approves AstraZeneca’s Calquence for Previously Untreated Mantle Cell Lymphoma
January 17th 2025Approval 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.