Live pharma industry news from FDA, Fierce Pharma, and BioPharma Dive. Updated continuously with the latest drug pricing, regulatory, and market developments.
Original data-driven analysis from the RxFinder team.
HRSA’s 2026 audits are zeroing in on eligibility, prescription origination, and contract pharmacy matching at women’s health clinics.
How rural health clinics can align with HRSA’s 2026 audit focus on provider eligibility, dispensing records, and contract pharmacy oversight.
HRSA’s 2026 contract pharmacy oversight focuses on restocking delays tied to manufacturer shipping pauses and ESP data mismatches.
HRSA’s 2026 340B audits are targeting clinic-dispense programs. Here’s how pharmacy-owned clinics can prove prescription origin and link inventory cleanly.
HRSA’s 2026 340B audits are hitting outpatient mental health clinics harder on eligibility proof and contract pharmacy claim checks.
HRSA’s 2026 enforcement focus on telehealth-dispensed 340B prescriptions is exposing diversion risks for FQHC and hospital covered entities.
HRSA audits in 2026 are targeting outpatient surgery centers in 340B. Here’s how to track inventory, handle contract pharmacies, and stay compliant.
HRSA audits in 2026 are zeroing in on hospital 340B discharge prescription conversions from inpatient stock, raising new compliance risks.
HRSA’s 2026 oversight of 340B ESP data and manufacturer access restores is testing covered entities’ compliance systems and data accuracy.
HRSA's 2026 audits now target specialty drug replenishment and contract pharmacy oversight, demanding precision in split-billing accuracy and data validation.
HRSA’s 2026 oversight of 340B contract pharmacy profit retention exposes gaps in pricing transparency, rebate practices, and covered entity accountability.
HRSA’s 2026 oversight of 340B shortage substitutions is catching covered entities that swap NDCs in contract pharmacies without proper tracking.
HRSA’s 2026 audits target 340B duplicate discounts in contract pharmacies, focusing on state Medicaid mismatches and manufacturer rebate exposure.
HRSA’s 2026 audits emphasize 340B compliance for hematology and transplant infusion drugs, demanding airtight inventory tracking and audit-proof records.
How HRSA’s 2026 oversight priorities are reshaping 340B compliance for specialty pharmacies and limited-distribution drugs.
HRSA is tightening oversight on 340B insulin discounts for FQHC Look-Alikes and contract pharmacies facing manufacturer access conditions in 2025.
HRSA’s 2025 enforcement push on child site registration and Medicaid carve-in rules will upend how hospitals handle off-campus clinics under 340B.
How covered entities should train pharmacy residents on 340B compliance and HRSA documentation standards in 2025 amid tighter oversight.
HRSA is focusing 2025 340B audits on pediatric-use formulations. Children’s hospitals need airtight compliance documentation for outpatient prescribing.
How oncology infusion sites can align 340B split-billing controls with HRSA’s 2025 audit priorities and avoid diversion or duplicate discounts.
Behavioral health drugs create unique 340B compliance risks. Here’s how covered entities should handle HRSA oversight, billing, and coordination in 2025.
How to build a 340B infusion center inventory reconciliation process that stands up to HRSA’s 2025 audit priorities and stops diversion at the source.
HRSA’s 2025 ceiling price enforcement rule raises the stakes for manufacturers and covered entities in 340B pricing and inflationary penalties.
HRSA’s 2025 audits show orphan drug exclusion errors remain a top compliance risk for Rural Referral Centers and Critical Access Hospitals.
Live headlines from leading pharma and regulatory news sources. Links open original articles.
Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.
FDA Novel Drug Therapy Approvals for 2026
The U.S. Food and Drug Administration today approved Mimrylo (rusfertide), a new treatment for adults with polycythemia vera, a rare blood disorder that causes the body to make too many red blood cell
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News about human drug-related approvals
The U.S. Food and Drug Administration has approved Stelara (ustekinumab) injection for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients aged 2 years old and
Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics.
This meeting serves as a checkpoint midway in the stabilization period, affording industry, FDA and others an opportunity to share stabilization progress that has been made, stabilization activity tha
Moderna's upsized note offering quickly followed a big win in a crucial study. Elsewhere, a biotech's shares tumbled after study data were "inadvertently" published ahead of a medical meeting.
Results published in NEJM raised questions about the benefits "silencer" medications provide on top of standard therapies for TTR cardiomyopathy and amplified investor pressure on Alnylam.
Not only is the XBI continuing to hover around a historic high, but drug companies can't seem to get enough of both large IPOs and big-ticket M&A.
Lisraya's clearance marks the first approval of a drug the Roivant subsidiary licensed from Pfizer and has since positioned against multiple rare inflammatory conditions.
Though its data could be useful for pharmaceutical firms, Polansky's latest entrepreneurial endeavor, Outer Bio, is serious about steering clear of road bumps that slow biotechs.
Tezspire succeeded in a study in eosinophilic esophagitis, which could become the drug's third approved indication and unlock what's viewed as a blockbuster opportunity.
Rasonque's $39,800 monthly list price surpassed Wall Street forecasts and led to rosier sales projections ahead of what one analyst described as a "historic" launch.
Rasonque's speedy approval - just a month after a completed submission - represents a paradigm shift for a notoriously deadly cancer and begins what analysts see as a highly lucrative drug launch.
After a surprise washout in a recent phase 3 trial of AstraZeneca and Ionis’ antisense oligonucleotide Wainua, the likely reason for the miss is being laid bare, in a potential ill omen for others pur
The FDA has approved Takeda’s Mimrylo (rusfertide) for polycythemia vera, introducing a new mechanism to the nonmalignant rare blood cancer and handing CEO Julie Kim another major regulatory win since
In their high-profile competition in the diabetes and obesity markets, Eli Lilly has proven adept at playing catch-up with Novo Nordisk. On Friday, Lilly checked another item off that list as it secur
In this week’s episode of “The Top Line,” Fierce’s Ben Adams and Zoey Becker discuss how pharma marketing is evolving across social media, creative work and agency strategy.
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