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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How HRSA defines eligibility and registration for 340B child sites and off-site outpatient facilities in 2026, and what makes them auditable.
Practical 340B compliance guide for setting up split-billing software to align virtual inventory, purchasing, and dispensing data.
How HRSA defines 340B overcharges, validates manufacturer data, and compels refunds when ceiling prices are exceeded in 2026.
HRSA’s 340B contract pharmacy registration hinges on verified site eligibility, written agreements, and precise OPAIS records.
HRSA’s duplicate discount prohibition defines Medicaid overlap rules and recordkeeping expectations that every 340B covered entity must understand.
HRSA’s 2026 audits are tightening around Medicaid Exclusion File accuracy and duplicate discount controls for FQHCs and community health centers.
FQHCs are under tighter HRSA audit scrutiny in 2026: eligibility records, Medicaid duplicate discount flags, and contract pharmacy inventory data are key.
HRSA’s 2026 enforcement push exposes how health system mergers disrupt 340B eligibility, contract pharmacy integrity, and re-registration.
How HRSA’s 2026 audits are reshaping 340B compliance expectations for oncology infusion centers, from infusion notes to contract pharmacy claim matching.
HRSA’s 2026 scrutiny of 340B diversion controls now targets specialty pharmacy shipments, patient definitions, and contract pharmacy oversight.
Live headlines from leading pharma and regulatory news sources. Links open original articles.
This page describes recent rare disease drug approvals that received a CDER or FDA communication. This is not an exhaustive list of all rare disease drug approvals.
Terms of the deal announced Tuesday are very similar to those the FTC reached with Express Scripts earlier this year, including requiring the PBM to stop preferring higher cost versions of drugs on st
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.
Learn about the warnings for pain and arthritis products that contain hidden drugs and other hidden ingredients.
The Food and Drug Administration is advising consumers not to purchase or use Xian Ling, a product promoted and sold for pain on various websites and in some retail stores.
FDA is advising consumers not to purchase or use Tawon Liar, a product promoted and sold for pain, rheumatism, insomnia, improving the immune system, increasing energy, and lowering cholesterol on var
Learn more about recent news and events related to rare diseases and read ARC Program Annual Reports.
Learn about the warnings for weight loss products that contain hidden drugs and other hidden ingredients.
See updates from CDER on fast-moving issues and learn about CDER's work to enhance public health
The ruling from a Cayman Islands court adds a new wrinkle to an ongoing legal dispute that's already resulted in a bankruptcy filing - and a bid by general partner Seth Harrison for the firm's portfol
Set to go public via a reverse merger, Avere has licensed from a prolific Chinese drugmaker rights to a potential threat to medicines like Skyrizi and Icotyde.
The cash will support mid-stage trials of a prospect the company claims to have "best-in-disease" potential treating major depressive disorder.
The study provides the clearest evidence yet that medicines like BIIB080 might improve cognition, but leaves unclear why higher doses didn't perform better.
The new study results could make Abbott, which has an agreement with Freenome to market the blood-based test, the dominant player in colorectal cancer screening, Evercore ISI analysts said.
Nearly two years after clinical setbacks cratered Q32's stock price, new results showed hair growth improvements that surpassed investors' expectations.
Agenus is financially abandoning an ongoing study in late-line colorectal cancer. Elsewhere, an ebola vaccine began human testing and an important Bristol Myers medicine got an FDA decision date.
The FDA has approved a new small molecule inhibitor from Celcuity with blockbuster potential that could become a new standard-of-care for patients with breast cancer.
Senior Director Kate Woda breaks down what attendees can expect at the Partnerships with Sites Summit, happening Sept. 14, 2026 in Boston, MA.
In the second of a new series of interviews with top executives from leading healthcare and comms agencies, Fierce Pharma Marketing sat down with London-based Havas SO’s managing director, Joanna Quad
Huyabio has scored a win in the largest oncology study it has undertaken in its 22 years, as its oral histone deacetylase inhibitor HBI-8000 has succeeded in combination with Bristol Myers Squibb’s Op
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