FDA

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.

In the final part of our conversation with Ryan Conrad, visiting fellow at the Center on Health Policy at the Brookings Institution, he discusses how FDA’s new program may or may not impact manufacturing pipelines.

The filing follows the completion of a pivotal study targeting abdominal conditions.

Ryan Conrad, visiting fellow at the Center on Health Policy at the Brookings Institution, continues his conversation about FDA’s Priority Review Voucher Program, and explains what the industry can learn from the announced participants.

The FDA approves multiple new drugs, enhancing treatment options for cancer and other conditions.

The first wave of Commissioner’s National Priority Vouchers signals a fundamental shift in FDA competitiveness, rewarding companies that pair breakthrough science with affordability commitments, onshore manufacturing readiness, and the operational muscle to execute ultra-accelerated reviews.

Epkinly plus rituximab and lenalidomide is the first bispecific antibody combination FDA-approved for relapsed or refractory follicular lymphoma, backed by Phase III data showing substantially improved disease control over standard therapy.

The FDA’s new Commissioner’s National Priority Voucher signals a transformative shift in U.S. drug review, tying accelerated approval to manufacturing readiness, domestic supply-chain strength, and credible affordability commitments, while redefining how companies must innovate, scale, and launch therapies in 2025 and beyond.

Approval of Komzifti (ziftomenib) provides a new targeted option for a high-risk patient population and strengthens the Kura Oncology–Kyowa Kirin collaboration, which includes a global development and commercialization strategy.

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

Following the removal of George Tidmarsh, HHS and FDA has appointed Richard Pazdur, M.D., director of CDER.

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.

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.