United States Food and Drug Administration
Novo Nordisk Seeks FDA Restriction on Victoza Compounding Amid Ongoing GLP-1 Supply Issues
Novo Nordisk, FDA, Victoza, liraglutide, compounding, GLP-1, supply issues, pharmaceutical regulation
2024 FDA Drug Approvals: A Year of Strategic Approvals and Long-Awaited Treatments
FDA drug approvals 2024, novel drug approvals, accelerated approvals, cancer treatments, rare disease therapies
2024 FDA Drug Approvals: Small Companies Make Significant Impact
FDA drug approvals 2024, small biotech companies, pharmaceutical industry, new drug approvals, regulatory updates.
Eli Lilly Seeks to Intervene in FDA Lawsuit Over Compounded Tirzepatide to Safeguard Interests
Eli Lilly, FDA lawsuit, compounded tirzepatide, weight loss drugs, pharmaceutical industry, regulatory issues
FDA Approves First Generic Version of Victoza (Liraglutide) for Type 2 Diabetes Treatment
FDA approval, generic Victoza, liraglutide, GLP-1 receptor agonist, Type 2 diabetes treatment, affordable medication options
Eli Lilly Intervenes in Lawsuit to Block Compounded Versions of Tirzepatide Following FDA’s Shortage Resolution
Eli Lilly, tirzepatide, GLP-1 shortage, FDA, compounding pharmacies, lawsuit, Mounjaro, Zepbound
Novartis Achieves Pivotal Trial Success for Intrathecal Zolgensma in Older SMA Patients After FDA Delay
Novartis, Zolgensma, Intrathecal formulation, Spinal muscular atrophy (SMA), FDA approval, Pivotal phase 3 trial, Older SMA patients
Bristol Myers Squibb Marks Milestone with FDA Approval of Subcutaneous Opdivo Qvantig
Bristol Myers Squibb, Opdivo, subcutaneous administration, FDA approval, cancer treatment, immuno-oncology, PD-1 inhibitor.
Axsome to Pursue FDA Approval for Alzheimer’s Agitation Treatment Despite Mixed Trial Results
Axsome Therapeutics, Alzheimer’s disease agitation, FDA approval, mixed trial data, AXS-05
FDA Approves Subcutaneous Formulation of Bristol Myers’ Opdivo for Solid Tumor Indications
FDA approval, subcutaneous Opdivo, Bristol Myers Squibb, cancer treatment, immunotherapy, nivolumab, hyaluronidase