Regulatory

The third entry in our premium webinar series dives into the implications the MFN order might have on wider market.

FDA's approval of Kygevvi as the first treatment for thymidine kinase 2 deficiency offers hope to patients and families affected by this rare disease.

Join us for a premium webinar on November 4, 2025!

Texas filed its lawsuit just days before Kennedy made his remarks.

The agency says the new guidelines will simplify the requirements to bring biosimilars to market.

The FDA has approved a new single-injection, once-monthly maintenance regimen for Eli Lilly’s Omvoh (mirikizumab-mrkz), offering adults with moderately to severely active ulcerative colitis a more convenient dosing option that maintains proven efficacy and long-term remission outcomes.

The FDA has updated the label for Merck’s Winrevair (sotatercept-csrk) following results from the Phase III ZENITH trial, confirming the therapy’s ability to reduce the risk of clinical worsening events in adults with pulmonary arterial hypertension.

Lynkuet, a hormone-free therapeutic option for hot flashes associated with menopause, is expected to be available in the United States in November 2025.

The proposed change would add a warning about an increased risk of autism, despite a lack of scientific evidence connecting the medication to the condition.

An analysis of pricing data for 12 high-revenue drugs from Medicare Part B and Part D compares US wholesale acquisition costs with the lowest prices in reference countries under the most-favored nation model.

Amid converging pharma pricing trends, such as those triggered by the Inflation Reduction Act, companies must adopt novel operational practices and strategic approaches in line with new parameters for success across a product’s lifecycle.

Sanofi's Tzield gains FDA's expedited review, promising rapid access to innovative treatment for type 1 diabetes and addressing significant medical needs.

Amgen and AstraZeneca’s Tezspire (tezepelumab-ekko) gains FDA approval as an add-on maintenance therapy for patients aged 12 and older with inadequately controlled chronic rhinosinusitis with nasal polyps.

The President claimed that prices would drop significantly based on government negotiations.

EMD Serono partners with the U.S. government to enhance IVF access, offering significant discounts on fertility treatments for millions of women.

At the heart of this moment is a growing unpredictability in how U.S. healthcare policy is being shaped.

The company’s CEO will reportedly joining the President to announce the deal.

In the second part of Pharm Exec’s webinar series, experts discuss the changing landscape surrounding the MFN executive order.

Serialization changes what's possible.

In today’s Pharmaceutical Executive Daily, we cover the FDA lifting its clinical hold on Neurizon Therapeutics’ lead program Nuz-001, the agency’s export ban on Sun Pharma’s Halol facility, and new insights on how small biotechs can better navigate regulatory and market complexities.

CDC introduces shared-decision making for COVID-19 vaccinations, emphasizing informed consent and individual consultation with healthcare providers.

Products tested and manufactured exclusively from domestic materials will be eligible for the program.

This marks the latest change in the President’s strategy.

How cell and gene therapy developers can lessen the chances of receiving FDA complete response letters through the use of proactive chemistry, manufacturing, and controls strategies.

The FDA has expanded Johnson & Johnson’s Tremfya (guselkumab) approval to children six years and older weighing at least 40 kilograms with moderate to severe plaque psoriasis or active psoriatic arthritis, marking the first pediatric approval of an IL-23 inhibitor for these conditions.