FDA

FDA approved AstraZeneca’s Fasenra for hypereosinophilic syndrome in patients aged 12 and older, expanding the IL-5 receptor-targeting therapy into a third eosinophil-driven disease with limited treatment options.

In today's Pharmaceutical Executive Daily, the FDA grants accelerated approval to BeOne Medicines' Beqalzi as the first and only BCL2 inhibitor for relapsed or refractory mantle cell lymphoma, while also approving Taiho Oncology's Inqovi in combination with venetoclax for newly diagnosed acute myeloid leukemia, Pharmaceutical Executive reports on the Doceree Makers Summit, and Dean Erhardt argues that AI-enabled workflow automation offers a practical path to fixing the prior authorization system's chronic failures.

FDA has approved BeOne Medicines’ Beqalzi for relapsed or refractory mantle cell lymphoma and Taiho Oncology’s Inqovi plus venetoclax for newly diagnosed acute myeloid leukemia, expanding treatment options for patients with difficult-to-treat blood cancers.

FDA has approved Partner Therapeutics’ Bizengri for NRG1 fusion-positive cholangiocarcinoma, expanding precision oncology options for a rare subset of gastrointestinal cancer patients with limited targeted treatment alternatives.

President Trump is reportedly planning to dismiss FDA Commissioner Marty Makary, adding further leadership uncertainty across U.S. health agencies.

In today’s Pharmaceutical Executive Daily, the FDA extends its priority review of a subcutaneous formulation of Leqembi, industry analysts examine how upcoming GLP-1 patent expirations could reshape the drug delivery device market, and experts discuss the key forces driving renewed growth in radiopharmaceuticals.

FDA extended its review of Leqembi’s once-weekly subcutaneous starting dose for early Alzheimer’s disease by three months after requesting additional information from Eisai and Biogen.

FDA clears Cellenkos’ IND for CK0802, enabling a mid-stage trial in steroid-refractory GVHD.

FDA advisory panel backs Truqap combination in PTEN-deficient prostate cancer, signaling potential expansion into biomarker-defined mHSPC population with limited treatment options.

FDA approves Auvelity for Alzheimer’s-related agitation, marking the first therapy targeting NMDA and sigma-1 receptors for this high-burden neuropsychiatric symptom and expanding treatment options for millions of patients.

Rocket Pharmaceuticals sells it's priority review voucher for $180M, securing non-dilutive funding to extend runway and advance gene therapy pipeline.

FDA approves Breztri Aerosphere for asthma, introducing the first single-inhaler triple-combination maintenance therapy for patients aged 12 and older.

FDA approves Caplyta for relapse prevention in schizophrenia, adding long-term Phase III data showing a 63% reduction in relapse risk and reinforcing its role in sustained disease management.

FDA granted Compass Pathways with a rolling review for COMP360, a proprietary formulation of synthetic psilocybin, in treatment-resistant depression.

FDA issues Complete Response Letter to AbbVie’s trenibotulinumtoxinE, delaying a potential first-in-class aesthetic neurotoxin over manufacturing questions despite no identified safety or efficacy concerns.

Early clinical data from the CHORD trial supported accelerated approval of the first gene therapy targeting OTOF-related hearing loss under the FDA Commissioner’s National Priority Voucher program.

FDA expands its approval of Tzield to children as young as one with stage 2 type 1 diabetes, extending the first disease-modifying therapy into an earlier, high-risk population to delay progression to insulin-dependent disease.

FDA expands Dupixent approval to children aged 2–11 with chronic spontaneous urticaria, marking the first biologic option for this population and extending its reach across type 2 inflammatory diseases.

FDA has approved Merck’s Idvynso, introducing a differentiated, two-drug, non-INSTI, tenofovir-free HIV regimen that maintains viral suppression while offering a potentially more tolerable, simplified option for long-term patient management.

The Trump administration’s new executive order aims to accelerate FDA review of psychedelic therapies for mental health conditions, highlighting a potential shift in regulatory timelines and expanded access pathways,

A new ICER white paper calls for reforms to the FDA’s accelerated approval pathway, citing ongoing challenges with regulatory consistency, confirmatory trial delays, and transparency.

FDA has fully approved Travere’s Filspari for focal segmental glomerulosclerosis, making it the first approved therapy for the rare kidney disease and expanding its role beyond IgA nephropathy.

Replimune received a second FDA complete response letter for RP1 in advanced melanoma, raising questions about the viability of its oncolytic immunotherapy program.

Dismissing the role of independent, outside experts in FDA decision-making weakens the drug review process.

Since the start of President Trump's second term, the FDA, CDC, CDER, and CBER have collectively cycled through more than a dozen leadership changes.