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Fda Approval

All articles tagged with #fda approval

Sanofi wins FDA nod for subcutaneous Sarclisa with on-body injector
health12 hours ago

Sanofi wins FDA nod for subcutaneous Sarclisa with on-body injector

The FDA approved Sanofi’s Sarclisa Escena, a subcutaneous version of Sarclisa that can be delivered by hand or Enable Injections’ CirCLIQ on-body injector, marking the first subcutaneous anticancer therapy usable with an OBI. In a phase 3 trial in relapsed/refractory multiple myeloma after at least one prior line, Sarclisa Escena plus pomalidomide and dexamethasone achieved an objective response rate of 71.1%—non-inferior to 70.5% with the IV Sarclisa–pomalidomide–dexamethasone regimen—while reducing administration time. The device’s rollout positions Sanofi to better compete with Johnson & Johnson’s Darzalex Faspro. Europe had already cleared OBIs for Sarclisa, and J&J highlighted Darzalex’ broader indications and established, monthly dosing in its own subcutaneous form.

via Fierce Pharma|
#darzalex-competition#fda-approval#health
FDA panel endorses Moderna’s next-gen mRNA flu shot for older adults
health22 days ago

FDA panel endorses Moderna’s next-gen mRNA flu shot for older adults

An FDA advisory panel unanimously recommended Moderna’s mRNA flu vaccine (mFlusiva) for adults 50 and older, approving it for two age groups (50–64 and 65+), with a requirement for an additional post‑market trial in the older cohort. In trials, the shot was about 27% more effective than standard flu vaccines. If FDA and then CDC sign off, it could become the first mRNA influenza vaccine, and its flexible, quickly updated design could help match circulating strains, though final timelines and access this fall remain uncertain amid regulatory and political considerations.

via NBC News|
#fda-approval#health#influenza-vaccine
Tick bites can trigger a mammal-meat allergy: the rise of alpha-gal syndrome and new treatments
health27 days ago

Tick bites can trigger a mammal-meat allergy: the rise of alpha-gal syndrome and new treatments

Alpha-gal syndrome is a mammal-meat allergy triggered when certain ticks inject the sugar alpha-gal into the bloodstream, provoking antibodies and reactions hours after eating beef, pork, or lamb. Cases are rising as tick habitats expand, and diagnosis combines symptoms with blood tests (which can yield false positives). Management centers on avoiding mammal meats and certain byproducts; a small number of pigs engineered to lack alpha-gal (GalSafe) are FDA-approved for consumption, and the FDA approved Xolair (omalizumab) in 2024 to reduce severe reactions, with more therapies in the works. The allergy can fade in 15–20% of people after years with strict tick-bite avoidance.

via The Independent|
#alpha-gal-syndrome#fda-approval#health
Napkin Sketch to Breakthrough: How a Baby's Death Redefined Inflammation Treatment
health1 month ago

Napkin Sketch to Breakthrough: How a Baby's Death Redefined Inflammation Treatment

A baby’s death in the arms of a young neurosurgeon in 1985 propelled Dr. Kevin Tracey to devote his career to understanding inflammation. His decades of research culminated in the FDA’s 2025 approval of the SetPoint System, a tiny implanted device that stimulates the vagus nerve to dampen inflammation in rheumatoid arthritis, with hopes it could treat other inflammatory diseases—an achievement born from a napkin sketch and a tragedy that reshaped medical science about inflammation.

via CNN|
#bioelectronic-medicine#fda-approval#health
Galleri Cancer Test Shows Early Gains but No Proven Mortality Benefit Yet
health1 month ago

Galleri Cancer Test Shows Early Gains but No Proven Mortality Benefit Yet

Grail’s $950 Galleri blood test, which screens for dozens of cancers via tumor DNA in the blood, produced mixed results in a UK study of more than 140,000 older adults: adding Galleri to annual screening detected about 937 additional cancers but did not meaningfully reduce late-stage (Stage 3/4) cancers, with a sensitivity around 30% and 2,114 cancers missed after a negative result. Some cancers—like ovarian, myeloma, and esophageal cancers—showed notable early-stage detection gains, but overall mortality benefit remains unproven. The test is not FDA-approved and is available via prescription or telehealth; experts say it could be an add-on to standard care but is not yet a replacement for conventional screening.

via Business Insider|
#asco-study#cancer-screening#early-detection
KRAS-targeting drug doubles survival in pancreatic cancer, fueling hope for broader use
health1 month ago

KRAS-targeting drug doubles survival in pancreatic cancer, fueling hope for broader use

Phase 3 results show the KRAS-targeting drug daraxonrasib doubles median survival in advanced pancreatic cancer (13.2 months vs 6.7 with chemotherapy), with FDA fast-track and expanded-access moves under way. The oral drug works by binding the KRAS-driven protein via cyclophilin A and appears less toxic than chemo, prompting optimism about its use in other KRAS-driven cancers, though it is not a cure and researchers are exploring where it fits in treatment sequences.

via NBC News|
#clinical-trial#daraxonrasib#fda-approval
FDA approves first-in-class Auvelity for agitation in Alzheimer’s disease
health2 months ago

FDA approves first-in-class Auvelity for agitation in Alzheimer’s disease

The FDA has approved Axsome Therapeutics’ Auvelity (dextromethorphan–bupropion) as a first-in-class treatment for agitation in Alzheimer’s disease, targeting NMDA and sigma-1 receptors. Agitation affects up to about 70% of patients and worsens caregiver burden and mortality. In phase 3 trials ACCORD-2 and ADVANCE-2, Auvelity delayed relapse of agitation compared with placebo (ACCORD-2: hazard ratio 0.275, P=0.001; relapse 8.4% vs 28.6%). ADVANCE-2 did not meet its primary CMAI endpoint but showed numerical improvements. Auvelity had FDA Breakthrough Therapy designation and an sNDA was submitted in 2025. Experts say this provides a meaningful new option with a favorable safety profile, potentially easing patient and caregiver burden.

via Psychiatric Times|
#agitation#alzheimer-disease#axsome-therapeutics
FDA Clears Non-Antipsychotic Help for Agitation in Alzheimer’s Dementia
health2 months ago

FDA Clears Non-Antipsychotic Help for Agitation in Alzheimer’s Dementia

The FDA expanded the use of Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) to treat agitation in adults with Alzheimer’s disease–related dementia, marking the first non-antipsychotic approved for this symptom. In two randomized trials, Auvelity improved agitation measures and extended time to relapse with continued treatment. Common side effects include dizziness, upset stomach, headache, diarrhea, drowsiness, dry mouth, sexual dysfunction, and sweating; there is a boxed warning for suicidality in adolescents/young adults and risks of seizures, high blood pressure, and mood activation. Pre-treatment assessments include blood pressure checks and bipolar-history screening. The approval was granted to Axsome Therapeutics, supported by breakthrough therapy and priority review designations.

via fda.gov|
#agitation-in-dementia#alzheimers-disease#auvelity
Alzheimer's blood tests spark debate over predicting risk and guiding care
health2 months ago

Alzheimer's blood tests spark debate over predicting risk and guiding care

Alzheimer's blood tests that detect amyloid or tau are being considered for early risk assessment, but doctors say their predictive value for asymptomatic people is uncertain, with potential false positives/negatives and no clear benefit from early intervention; FDA has cleared two tests for symptomatic patients, not for screening; patient interest is high, with surveys showing many would take a test if advised, though distress is common.

via NBC News|
#alzheimers#amyloid#blood-tests
FDA backs first gene therapy to treat a rare genetic deafness (Otarmeni) with free US access
health2 months ago

FDA backs first gene therapy to treat a rare genetic deafness (Otarmeni) with free US access

The FDA approved Otarmeni, Regeneron’s gene therapy for OTOF-related deafness—the first gene therapy for this rare inherited hearing loss—delivered via a single cochlear injection to restore otoferlin production. In a 20-child trial, several participants showed hearing improvements, with five of 12 followed for 11 months reaching near-normal hearing. Regeneron will provide Otarmeni at no cost to US patients, and the therapy was fast-tracked under the Commissioner’s National Priority Voucher program. While promising, effects were generally safe, the condition affects about 50 US babies born each year, and this advance could pave the way for more gene therapies and potentially reduce reliance on cochlear implants.

via New York Post|
#fda-approval#gene-therapy#health
FDA approves Otarmeni, first gene therapy for rare OTOF-related infant hearing loss
health2 months ago

FDA approves Otarmeni, first gene therapy for rare OTOF-related infant hearing loss

FDA approves Regeneron's Otarmeni, the first gene therapy for a rare OTOF-mutation–driven hearing loss in infants; in a trial, a single-dose inner-ear injection improved hearing in 16 of 20 children, with some able to detect whispers; the company will provide the drug for free to U.S. patients, while pricing outside the U.S. has not been determined since it is not approved there.

via NBC News|
#fda-approval#gene-therapy#health
Merck’s IDVYNSO earns FDA nod as a once-daily, two-drug HIV regimen
health2 months ago

Merck’s IDVYNSO earns FDA nod as a once-daily, two-drug HIV regimen

FDA approved IDVYNSO, a once-daily two-drug regimen (doravirine/islatravir) for adults with virologically suppressed HIV-1, intended to replace their current antiretroviral therapy. It is the first non-INSTI, tenofovir-free two-drug therapy to demonstrate non-inferiority to a three-drug regimen in two Phase 3 trials (052 vs BIKTARVY and 051 vs baseline ART). The product will be available in pharmacies after May 11 and carries contraindications with strong CYP3A inducers and with lamivudine or emtricitabine, plus safety considerations including potential severe skin reactions and drug interactions. Trials enrolled 708 participants with diverse demographics, supporting another option in HIV treatment.

via Merck.com|
#fda-approval#health#hiv
FDA Grants Accelerated Approval for KRESLADI to Treat Pediatric LAD-I
healthcare3 months ago

FDA Grants Accelerated Approval for KRESLADI to Treat Pediatric LAD-I

Rocket Pharmaceuticals announced that the FDA granted accelerated approval for KRESLADI (marnetegragene autotemcel), an autologous hematopoietic stem cell–based gene therapy for pediatric patients with severe LAD-I due to ITGB2 variants who lack an HLA-matched donor. Approval is based on increased neutrophil CD18/CD11a expression and will rely on longer-term follow-up data and a post‑marketing registry to confirm benefit. The FDA also awarded Rocket a Rare Pediatric Disease Priority Review Voucher, which the company plans to monetize. LAD-I is ultra-rare and causes recurrent life-threatening infections; safety concerns include infections during conditioning, veno-occlusive disease, engraftment failure, potential insertional oncogenesis, hypersensitivity, anti-retroviral interactions, and possible HIV test false positives, necessitating long-term monitoring. A conference call is planned for March 27, 2026.

via Business Wire|
#fda-approval#gene-therapy#healthcare