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The defendants are barred from seeking or accepting reimbursement for any Gilead medication dispensed to individuals enrolled in the programs. Read More
Boise, Idaho-based Episciences was issued an 8-observation Form 483 for missing testing procedures, deficient cleaning and other quality lapses. Read More
A three-judge panel has rejected Pfizer’s plan to help Medicare patients pay for one of its most expensive drugs, citing the federal anti-kickback statute. Read More
The FDA has granted priority review status to Biogen’s New Drug Application for tofersen, giving the drugmaker an early win in its battle for an amyotrophic lateral sclerosis (ALS) therapy. Read More
Sens. Cory Booker (D-N.J.) and Rand Paul (R-Ky.) introduced a bill yesterday seeking to update the Right to Try Act to permit terminally ill patients to access Schedule I drugs that have completed a phase 1 trial — including MDMA and psilocybin. Read More