The FDA is issuing exemptions from certain requirements of the Drug Supply Chain Security Act (DSCSA) to small dispensers such as pharmacies until Nov. 27, 2026. Read More

Due to a combination of confounding factors in the regulatory system and the market, patients in Europe wait an average of 531 days to access new medicines, according to three new reports published by the European Federation of Pharmaceutical Industries and Associations (EFPIA) this week. Read More

The US Supreme Court tossed out a challenge to the FDA’s approval of the use of the abortion drug mifepristone (Mifeprex), ruling that the plaintiffs did not have standing to bring the action. Read More

The House’s fiscal 2025 Agriculture-FDA bill, released Monday, keeps spending almost flat, providing the FDA with $6.75 billion in total funding, short of the agency’s $7.2 billion budget request. Read More

Alzheimer’s drugmakers including Biogen, Eli Lilly and Eisai, as well as consumer advocacy group Public Citizen, have characterized a recent FDA guidance on developing drugs for Alzheimer’s as lacking in specifics for later-stage disease progression. Read More

A New Jersey federal judge has ordered Teva Pharmaceuticals to remove from the Orange Book five patents on its ProAir HFA asthma inhalation device, clearing the way for Amneal Pharmaceuticals to launch a generic version. Read More

The FDA’s 11-person Peripheral and Central Nervous System Drugs Advisory Committee unanimously endorsed both the efficacy and safety of Lilly’s antiamyloid antibody donanemab, saying that people with Alzheimer’s disease and their clinicians should be the ones to decide whether the drug’s modest cognitive benefit outweighs its risk of serious adverse events. Read More

The FDA sent an untitled letter to Achieve Vitality, which markets a product claiming to offer regenerative therapy, for offering an injectable product derived from human umbilical cord for which the company lacks required regulatory approvals. Read More

The FDA has selected seven rare disease therapies to participate in its Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program to accelerate the development of novel drug products through, in part, enhanced communications with the agency. Read More