FDA

The approval is for a new formulation of the medication that allows for it be provided as an oral film.

FDA’s complete response letter for subcutaneous Saphnelo highlights regulatory scrutiny around manufacturing and formulation changes in the industry.

Tenpoint Therapeutics has paired FDA's approval for Yuvezzi with $235 million in new financing to support its U.S. launch and broader push into age-related vision loss.

FDA’s decision to withhold approval of Hetlioz for jet lag disorder underscores the agency’s continued insistence on real-world relevance in clinical evidence.

FDA’s decision to limit regulations of non-medical grade wearables marks a notable shift toward regulatory restraint in digital health.

FDA approval of Vanda’s Nereus marks a rare and meaningful regulatory milestone, introducing the first new pharmacologic option for motion sickness in decades and underscoring renewed innovation in a long-neglected but widely impactful condition.

The approval marks the first agency-cleared oral formulation of a GLP-1 drug for obesity.

Roche’s FDA approval of Lunsumio VELO as a one-minute subcutaneous bispecific therapy for relapsed or refractory follicular lymphoma marks a meaningful advance in reducing treatment burden while preserving strong response rates in later-line disease.

Novo Nordisk’s NDA filing for CagriSema positions the first fixed-dose amylin–GLP-1 combination as a potential next-generation obesity therapy, backed by Phase III data showing more than 20% weight loss and signaling the company’s intent to extend its leadership beyond single-mechanism incretins.

The approval is supported by Phase III SWIFT-1 and SWIFT-2 trial data showing that twice-yearly dosing of Exdensur significantly reduced annualized asthma exacerbation rates compared with placebo when added to standard of care.

The approval is based on Phase III DESTINY-Breast09 data showing the Enhertu–Perjeta combination significantly improved progression-free survival compared with the current taxane-based standard of care in previously untreated metastatic disease.

The FDA’s approval of Lerochol introduces a once-monthly, subcutaneous PCSK9 inhibitor for lowering LDL cholesterol in adults with hypercholesterolemia.

The 16th addition to the FDA Commissioner’s National Priority Voucher pilot program follows Phase III MajesTEC-3 trial data showing significant survival benefits for the Tecvayli-based regimen compared with standard of care in treating relapsed or refractory multiple myeloma.

The FDA’s approval of Uplizna for antibody-positive generalized myasthenia gravis introduces a twice-yearly CD19-targeted therapy option for the rare autoimmune condition.

Experts weigh in on FDA’s new accelerated review program, revealing what companies stand to benefit the most from the initiative.

Waskyra’s FDA approval marks a milestone for rare disease care and for Fondazione Telethon, establishing the first nonprofit-led ex vivo gene therapy to reach market after decades of research.

FDA’s approval of Augmentin XR as the first therapy cleared under the new National Priority Voucher Pilot Program signals a decisive push to strengthen domestic antibiotic manufacturing, accelerate critical drug reviews, and stabilize long-strained U.S. antimicrobial supply chains.

New FDA guidance signals a major shift for CAR-T development, calling for randomized trials with standard-of-care control groups and clear evidence of superiority over existing therapies, while simultaneously easing REMS requirements to reduce logistical burdens for treatment centers and patients.

FDA’s approval of Bristol Myers Squibb’s Breyanzi as the first CAR T therapy for relapsed or refractory marginal zone lymphoma underscores the therapy’s expanding leadership in B-cell malignancies, backed by compelling Phase II data

Twelve former FDA leaders have publicly challenged the agency’s proposed overhaul of vaccine approvals, sparked by an internal memo linking child deaths to COVID-19 vaccination, arguing the changes threaten evidence-based standards, weaken immunobridging practices, and risk eroding public trust.

The agency also named a new head of its Office of Nonprescription Drugs.

The former FDA oncology chief is set to resign by the end of the month.

The agency says that the decision aims to improve employee workflow and build on its previously implemented generative AI tool Elsa.

The agency’s decision is based on claims that the Covid vaccine was linked to the deaths of 10 children.

The company submitted the new dosage for approval based on its Phase III trial results.