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Regulatory Overview: Post-Approval Changes to Marketed Drugs - The popularity of GLP-1s have brought post-approval changes to New Drug Applications (NDAs) to centerstage. Recently...
Key Takeaways FDA has proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list. The proposal would materially limit 503B bulk compounding of these GLP-...
On April 30, 2026, the U.S. Food and Drug Administration (FDA) announced a proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulk Drug Substances List (“5...
Key Takeaways On April 1, 2026, FDA issued a statement reminding 503A pharmacies and 503B outsourcing facilities that compounded drugs qualify for the statutory exemptions under t...
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....By: Latham &...
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....By: Latham &...
By Charles D. Snow & Karla L. Palmer —
On April 16, 2026, the U.S. Food & Drug Administration (FDA) announced it will convene the Pharmacy Compounding Advisory Committee (PCAC) on July 23 and 24, 2026, to discuss pe...
As GLP-1 medications become an increasingly significant cost driver for employer-sponsored health plans, plan sponsors are seeking creative solutions beyond conventional pharmacy b...
Key Takeaways: FDA will convene the Pharmacy Compounding Advisory Committee (PCAC) on July 23-24, 2026, to discuss seven peptides for potential inclusion on the 503A bulks list. A...
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....By: Latham &...
Despite the flurry of reform activity throughout the first quarter of 2026, the pace of new PBM regulation and drug pricing reforms shows no sign of tapering off. Instead, both fed...
Key Takeaways Medspas and other entities operating in the aesthetic space that dispense or administer prescription drugs should assess whether they have obligations as dispensers...
This week, we're rerunning some popular posts while we prepare for Friday’s live video webinar: PBM Industry Update 2026: Trends, Challenges, and What’s Ahead. Click here to see...
While federal and state legislators contemplate the next wave of PBM and drug pricing reform, legislatures in Virginia and Ohio have already sent significant legislation addressing...
Key Takeaways - Medspas and other entities operating in the aesthetic space that dispense or administer prescription drugs should assess whether they have obligations as dispensers...
On April 14, 2026, the Centers for Medicare and Medicaid Services (“CMS”) published a proposed rule[1] that would require faster prior authorization (“PA”) decisions, expand electr...
By Charles D. Snow & Karla L. Palmer —
FDA released its FY 2027 congressional justification last week. The $7.2 billion topline is less interesting than what's underneath it—the budget translates this administration's p...
The popularity of GLP-1s have brought post-approval changes to New Drug Applications (NDAs) to centerstage. Recently, the FDA approved Wegovy in tablet form, offering an alternativ...
News Briefs - High Court Won't Hear Drug Manufacturer Price Negotiation Appeal - The Supreme Court declined to hear an appeal from six drug manufacturers that wanted the court to r...
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