FDA

Following a Type A meeting with the FDA’s Center for Biologics Evaluation and Research, Moderna’s flu vaccine candidate mRNA-1010 has been accepted for formal review after the company revised its regulatory strategy.

The new once-monthly dosing schedule for Rybrevant Faspro in combination with Lazcluze offers a more convenient option and also maintains efficacy and safety comparable to the prior bi-weekly regimen.

The letter follows Phase II data that did not sufficiently link biomarker reductions to clinical benefit.

The withdrawal is due to data shared from FDA reflecting that data included in the NDA submission is unlikely to meet the required threshold of evidence.

The approval of Keytruda (pembrolizumab) and Keytruda Qlex was supported by Phase III KEYNOTE-B96 data showing statistically significant improvements in progression-free and overall survival in patients with PD-L1–positive platinum-resistant ovarian, fallopian tube, or primary peritoneal carcinoma.

A regulatory setback for Moderna’s next-generation flu vaccine underscores mounting scrutiny of late-stage trial design in the U.S., even as the company pivots to international manufacturing partnerships to sustain momentum in its respiratory franchise.

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