Regulatory

FDA approves COVID-19 vaccines from Moderna, Pfizer-BioNTech, and Novavax targeting the LP.8.1 sublineage of SARS-CoV-2, with eligibility limited to adults aged 65 years and older and those with underlying medical conditions that place them with a high risk for severe disease.

New indication positions Repatha as an option for high-risk adults with elevated LDL cholesterol and no prior cardiovascular events.

Dawnzera is the first and only RNA-targeted prophylactic therapy to be approved for hereditary angioedema in adults and pediatric patients aged 12 years and older.

Rob Abbott, CEO, ISPOR, highlights how uniting regulators, payers, and academic leaders worldwide can accelerate access to innovative treatments and strengthen evidence-based healthcare.

The clinical hold is due to questions about BX004’s nebulizer device, temporarily pausing US enrollment in the cystic fibrosis Phase IIb trial (NCT06998043) while European dosing continues.

Ron Lanton, partner, Lanton Law, warns that ongoing lawsuits targeting vaccine policy could create ripple effects across FDA decision-making and reshape how future emergency use authorizations are granted.

EVERSANA’s Alan Crowther discusses how pharma can prepare for the impact of the order.

Ron Lanton, partner, Lanton Law, warns that recent changes to federal vaccine recommendations could trigger extensive litigation as insurers, providers, and patients face new access and coverage challenges.

Tomnya is the first new fibromyalgia therapy approved by the FDA in over 15 years.

Expanded approval of Wegovy was based on results from the Phase III ESSENCE trial (NCT04822181), which demonstrated significant improvements in patients with metabolic dysfunction-associated steatohepatitis and liver fibrosis compared to placebo at 72 weeks.

The order aims to set US drug prices at the same level as the lowest cost in other markets.

An examination of proactive preparedness and readiness review for future enrollment in the agency’s QMM program—now in the pilot stage as an effort to incentivize pharma manufacturers to achieve a more mature state of quality culture.

Papzimeos is the first-and-only approved therapy for adults with recurrent respiratory papillomatosis.

The federally created panel was previously disbanded in 1998.

Attorney General Paxton argues that the company’s programs and offerings were essentially bribes and resulted in millions in dollars charged to the state’s Medicaid program.

Brinsupri is a first-in-class DPP1 inhibitor that has been found to inhibit activation of neutrophil enzymes that drive chronic airway inflammation in non-cystic fibrosis bronchiectasis.

Accelerated approval was based on results from the Phase Ib Beamion-LUNG 1 trial (NCT04886804), which showed a 75% objective response rate in patients with unresectable or metastatic non-squamous non-small cell lung cancer treated with Hernexeos.

Vinay Prasad returns to lead the FDA's CBER after leaving in late July.

The talks are a result of the MFN order, which seeks to make US drug prices match lower prices in international markets.

Modeyso is the first and only approved treatment for recurrent H3 K27M-mutant diffuse midline glioma in patients aged one year and older.

The industry is facing calls to reduce prices while also bracing for increased tariffs.

Ajovy becomes the first-and-only calcitonin gene-related peptide agonist approved for pediatric patients aged six to 17 years with episodic migraine who weigh at least 99 lbs.

The move comes amidst a turbulent time at HHS.

The supplemental New Drug Application is supported by data from the Phase II TRANSCEND FL trial (NCT04245839), which showed that patients treated with Breyanzi for relapsed or refractory marginal zone lymphoma demonstrated strong and lasting responses.

Members of the industry believe the US should remain an innovation-friendly market.