Legal & Regulatory

US pharma supply chains are shifting amid regulation and geopolitics, with BIOSECURE driving less Asia reliance and more complex, distributed networks.

FDA commissioner Marty Makary is planning to resign today, according to sources close to the White House.

According to the Wall Street Journal, a source close to the White House said FDA commissioner Marty Makary "is done."

For drugs already on the market, there may be little companies can do to limit business impact; however, for new development drugs, there are some critical considerations.

At Asembia AXS26, Dee Chaudhary broke down how shifting US drug pricing policy is tightening payer controls and changing pharmaceutical pricing and forecasting.

Pharma importers can apply for tariff reimbursements through the US Customs and Border Protection’s online portal.

President Trump signed an executive order to fast-track FDA review of psychedelic therapies for mental health conditions.

Charley Maxwell explains why Annex 21 is not just a regulatory hurdle, but a key commercial risk point.

Mastering the PSMF is critical for inspection readiness, as it provides regulators an early look at your pharmacovigilance system's compliance.

Pharma companies could face 100% tariffs under new US rules, with relief available for those prioritizing onshore manufacturing or pricing concessions.

Eli Lilly’s newest GLP-1, Foundayo (orforglipron), is the first FDA-approved weight loss pill that can be taken without food or water restrictions.

How the zero-prefix collision will disrupt reimbursement, patient access, brand protection and market intelligence — and what commercial leaders must do before 2033.

The FDA launched AEMS, a unified platform that replaces fragmented legacy databases to enable real-time adverse event reporting.

In today’s Pharma Pulse, the FDA approved Wellcovorin as the first therapy for an ultra-rare neurological disorder, and disparities in OTC naloxone access persist despite declining retail prices.

In today's Pharma Pulse, Ipsen voluntarily withdraws tazemetostat due to safety signals, while the FDA approves deucravacitinib for active psoriatic arthritis.

The FDA is working with states to implement the Section 804 Importation Program, offering new regulatory enhancements for projecting cost savings on Canadian drug imports.

The FDA has transitioned to a "new era" of proactive enforcement, issuing warning letters to telehealth and pharmaceutical companies to eliminate misleading promotional claims and ensure a fair balance of risks and benefits regarding approved and compounded GLP-1 medications.

In today’s Pharma Pulse, the FDA grants priority review to a therapy for polycythemia vera, while Novo Nordisk receives expanded pediatric approval for its once-weekly growth hormone.

In today’s Pharma Pulse, the FDA grants a lightning-fast approval for Boehringer’s lung cancer therapy under its new priority program, while CMS Administrator Mehmet Oz launches a sweeping offensive against fraudulent billing.

The FDA granted accelerated approval to Boehringer Ingelheim’s Hernexeos for first-line HER2-mutant NSCLC following a 44-day review under the National Priority Voucher Program.

A guide to how the IRA is reshaping Medicare Part D, price negotiations, manufacturer liability, and pharmacy operations, along with what it means for access, adherence, and commercial strategy.

Rare disease drugs now drive innovation, investment, and portfolio strategy as policy incentives, scientific advances, and market success reshape biopharmaceutical growth.

In today’s Pharma Pulse, the FDA unveils a Plausible Mechanism framework to fast-track ultra-rare disease therapies, while Astellas partners with Vir Biotechnology in a massive $2.1 billion oncology collaboration.

The FDA’s Plausible Mechanism Framework is designed to facilitate the approval of highly individualized therapies for patients with ultra-rare diseases.