Regulatory

FDA introduces a new drug approval process, the Plausible Mechanism Pathway, streamlining drug approvals for personalized therapies targeting rare genetic diseases without traditional trials.

Per the FDA's request, HHS is updating hormone therapy labels, removing misleading warnings to empower women in managing menopause and improving their health options.

The FDA has added six new therapies to its Commissioner’s National Priority Voucher program, bringing the total to 15 products that address major public health needs, including obesity, cancer, sickle cell disease, and drug-resistant tuberculosis.

Johnson & Johnson secures FDA approval for Darzalex Faspro as the first and only treatment for adults with high-risk smoldering multiple myeloma, supported by Phase III Aquila trial data showing a 51% reduction in disease progression or death.

FDA’s approval of Caplyta as an adjunctive treatment to oral antidepressants for major depressive disorder in adults, expands the drug’s use to a fourth indication following positive Phase III trial results.

GLP-1 medications will be available on TrumpRx for discounted rates.

The motion is part of the state’s lawsuit against the Tylenol-maker based on unproven autism claims.

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!

Marcel Botha, CEO of 10XBeta, discusses FDA’s new pilot authorization program for abbreviated new drug applications (ANDA) and what impact it will have on manufacturing and the supply chain.

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

Marcel Botha, CEO of 10XBeta, discusses FDA’s new pilot authorization program for abbreviated new drug applications (ANDA) and what impact it will have on manufacturing and the supply chain.

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

Marcel Botha, CEO of 10XBeta, discusses FDA’s new pilot authorization program for abbreviated new drug applications (ANDA) and what impact it will have on manufacturing and the supply chain.

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.

Chris O’Dell, SVP of market solutions at Turquoise Health, explains the timeline to expect changes to prescription drug prices based on current DTC trend.

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.