How Microbial Preservation Supports Quality and Safety in Compounding Pharmacies
April 4th 2025Mark Mulvahill, MBA, MSc, discusses the importance of microbial preservation and reference materials in pharmaceutical manufacturing and compounding pharmacies, highlighting their role in contamination control, regulatory compliance, and enhancing microbiological testing reliability.
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Rilzabrutinib Granted Orphan Drug Designation For Multiple Rare, Immune-Mediated Conditions
April 4th 2025The new designations span both warm autoimmune hemolytic anemia and IgG4-related disease, 2 rare, immune-mediated conditions that burden patients due to a lack of available treatment options.
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FDA Grants Accelerated Approval to Atrasentan for Proteinuria Reduction in Primary IgA Nephropathy
April 3rd 2025Positive results from an interim analysis of the phase 3 ALIGN study bolstered atrasentan towards receiving accelerated approval for patients with immunoglobulin A nephropathy, a rare condition that can cause kidney failure.
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ELCC 2025: Amivantamab Plus Lazertinib Effective in EGFR-Mutated NSCLC Versus Standard of Care
April 2nd 2025Nicolas Girard, MD, explains the benefits observed in the MARIPOSA clinical trial among patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) treated with amivantamab plus lazertinib.
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Revolutionizing Treatment with Bispecific Therapies: Navigating the Challenges Ahead
April 2nd 2025By decade’s end, approval of additional bispecifics is expected for hematological malignancies, solid tumors, and non-oncology conditions such as inflammatory, autoimmune, neurodegenerative and vascular diseases, and ocular disorders and infections.
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