The FDA has accepted for review the New Drug Application for plozasiran for the treatment for familial chylomicronemia syndrome.

The Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for elamipretide for the treatment of Barth syndrome, a rare genetic disorder.

Trump rescinded Executive Order 14087, "Lowering Prescription Drug Costs for Americans," which directed Medicare and Medicaid ...

The FDA has accepted the BLA for lecanemab-irmb SC for weekly maintenance dosing in the treatment of early Alzheimer disease.

Since the announcement that president-elect Donald Trump would nominate Robert F. Kennedy Jr. (RFK Jr.) as the secretary of the U.S. Department ...

The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) for the treatment of adults with locally advanced ...

and substance use disorder, CMS said. Since April 1, 2023, people with Medicare have seen savings on over 120 drugs thanks to Inflation Reduction Act’s Medicare Prescription Drug Inflation ...

Replimune Group ( REPL, Financials) shares surged 17% to $11.85 as of 10:18 a.m. ET Tuesday after the U.S. Food and Drug ...

Separate provisions in the Inflation Reduction Act of ... 2000-prescription-drug-cap-january-1-2025-how-it-works/. Sayed, Bisma A., et al. Medicare Part D Enrollee Vaccine Use after Elimination ...

Eisai and Biogen are one step away from deploying a more convenient version of their jointly developed Alzheimer’s treatment ...

Orphan Drug Designation: a status given to drugs that are being developed to treat rare diseases or conditions. Prescription Drug User Fee Act (PDUFA): a law that allows the FDA to collect fees from ...

the third-party companies that act as middlemen and negotiate drug discounts and rebates between manufacturers, insurance companies and pharmacies. The law requires PBMs to use "pass-through ...