Live pharma industry news from FDA, Fierce Pharma, and BioPharma Dive. Updated continuously with the latest drug pricing, regulatory, and market developments.
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Detailed 2025 HRSA 340B recertification instructions to prevent data mismatches, account lockouts, or program termination for hospitals and grantees.
How to correct 340B eligibility documentation errors after a HRSA audit finding in 2025, with step-by-step context from real covered entity experiences.
How telehealth prescribing intersects with 340B patient definition, HRSA audits, and covered entity oversight in 2025.
HRSA’s 2025 crackdown on child site registration ties 340B eligibility to how hospitals bill for offsite clinics, forcing system-level compliance overhauls.
HRSA’s 2025 audits show rising duplicate discount findings in Managed Medicaid carve-ins, forcing hospitals and states to overhaul rebate exclusion protocols.
Many FQHCs lose 6-10% of 340B savings each year from wrong Medicaid Exclusion File reporting. Here’s how to fix it heading into 2025.
HRSA’s 2025 guidance tightened 340B mixed-use oversight. Here’s how to implement split-billing software that actually survives audit scrutiny.
How hospitals and grantees can stay compliant with 340B contract pharmacy limits after 2024 court rulings weakened HRSA’s enforcement powers.
HRSA’s 2024 contract pharmacy oversight is forcing covered entities to rethink diversion prevention, patient documentation, and audit defense.
HRSA’s 2024 340B audits are tougher on mixed-use areas, duplicate discounts, and patient eligibility, here’s what FQHCs and DSHs should check now.
Specialty drugs in 340B trip audits fast. This piece covers HRSA triggers, data pitfalls, and split-billing setup practices that actually work.
Live headlines from leading pharma and regulatory news sources. Links open original articles.
FOR IMMEDIATE RELEASE – August 19, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Containe
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.
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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