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Fda Approval

All articles tagged with #fda approval

health7 days ago•4 min saved

Early Detection and New RAS Inhibitors Aim to Triple Pancreatic Cancer Survival

Researchers are pursuing a strategy of 'cancer interception' to treat pre-cancerous pancreatic tissue before it becomes malignant, aiming to boost five-year survival from 13.7% to 50%. This approach leverages the recent FDA approval of daraxonrasib, a drug that nearly doubled median survival in metastatic cases. While current trials focus on advanced disease, new studies are testing the drug for early-stage prevention and screening.

via nature.com|

#cancer-interception #daraxonrasib #early-detection

health9 days ago•3 min saved

FDA Approves First RAS Inhibitor, Doubling Survival for Pancreatic Cancer Patients

The FDA has approved daraxonrasib (Rasonque), the first drug in its class to target RAS mutations, a breakthrough for pancreatic cancer. In a trial of 500 patients, the drug doubled median survival to 13.2 months compared to 6.7 months for chemotherapy. Developed by Revolution Medicines, the drug addresses a target previously deemed untargetable, offering new hope for a disease with a 13% five-year survival rate.

via Gizmodo|

#daraxonrasib #fda-approval #health

biotechnology10 days ago•0 min saved

uniQure Stock Plunges 41% as Huntington’s Gene Therapy Misses Key 48-Month Endpoint

uniQure shares dropped 41% after its Huntington’s disease gene therapy, AMT-130, failed to reach statistical significance on its primary endpoint at 48 months. While the composite Unified Huntington’s Disease Rating Scale (cUHDRS) showed only a 44% slowing of progression, the secondary Total Functional Capacity (TFC) endpoint remained strong at 61%. Analysts and executives argue that methodological flaws in the control group and the stability of functional outcomes support the drug’s path to accelerated FDA approval, despite the initial market sell-off.

via Fierce Biotech|

#amt-130 #biotechnology #fda-approval

biotech10 days ago

Kodiak Sciences Stock Doubles as Zenkuda Matches Eylea in Phase 3 Trial

Kodiak Sciences shares surged 128% after its Phase 3 trial showed its eye drug Zenkuda matched the efficacy of Regeneron’s Eylea for wet age-related macular degeneration. The company plans to file for FDA approval in the fourth quarter of 2026, leveraging an AI-guided dosing strategy that allows longer intervals between injections.

via fiercebiotech.com|

#biotech #eylea #fda-approval

biotech11 days ago•18 min saved

Kodiak Sciences stock triples as Zenkuda matches Eylea in Phase 3 trial

Kodiak Sciences shares surged nearly 178% after its Phase 3 Daybreak trial results showed that both Zenkuda and tabirafusp-ted matched the efficacy of aflibercept (Eylea) for wet age-related macular degeneration. The company plans to file for FDA approval of Zenkuda in the fourth quarter of 2026, citing data that allows for extended dosing intervals.

via Yahoo Finance|

#biotech #fda-approval #kodiak-sciences

biopharma11 days ago•18 min saved

Kodiak Sciences shares surge 178% after Zenkuda and tabirafusp-ted match Eylea in Phase 3 trial

Kodiak Sciences stock jumped 178% after its two eye drugs, Zenkuda and tabirafusp-ted, matched Regeneron’s Eylea in a Phase 3 trial for wet age-related macular degeneration. Zenkuda allowed over half of patients to receive injections only once every six months, compared to every eight weeks for Eylea. The company plans to file for FDA approval of Zenkuda in the fourth quarter of 2026.

via BioPharma Dive|

#biopharma #eylea #fda-approval

health-and-pharma11 days ago•1 min saved

AbbVie Secures FDA Approval for Juvmo, First D1/D5 Agonist for Parkinson's

AbbVie received FDA approval on Friday for tavapadon, branded as Juvmo, the first selective D1/D5 receptor agonist for adults with Parkinson's disease. The approval validates the company's $8.7 billion acquisition of Cerevel Therapeutics, which closed in August 2024. Juvmo is priced at $4,900 per 30-day supply and is expected to launch in the U.S. next month. While the deal's flagship asset, emraclidine, failed in schizophrenia trials in 2025, Juvmo's success provides a new growth avenue for AbbVie's neuroscience division.

via Fierce Pharma|

#abbvie #cerevel-therapeutics #fda-approval

biotech14 days ago•3 min saved

Kyverna reports durable, safe CAR-T results as rivals face safety pauses

Kyverna Therapeutics released one-year data for its CD19 CAR-T therapy, miv-cel, showing sustained efficacy and no severe safety events in stiff person syndrome and myasthenia gravis. The results contrast with recent safety pauses at Novartis and Bristol Myers Squibb, supporting Kyverna's FDA submission for a potential first-in-class autoimmune treatment.

via Fierce Biotech|

#autoimmune-disease #biotech #car-t-therapy

health18 days ago•409 min saved

Gene therapy eases daily cornstarch burden for teen with rare metabolic disease

Thirteen-year-old Trey McGowan has a rare glycogen storage disease Type 1a (von Gierke) that requires uncooked cornstarch every few hours to prevent dangerous lows; after FDA-approved gene therapy (Genglycos) his daily cornstarch intake dropped and feeds are now six per day, easing the family’s anxiety and keeping him on a life-sustaining regimen that will always include cornstarch.

via TODAY.com|

#cornstarch-therapy #fda-approval #gene-therapy

health21 days ago•6 min saved

First mRNA flu vaccine lands in US for adults 50 and older

Moderna’s mFlusiva is the first mRNA-based flu shot and is now available in the US for adults 50 and older (50–64 traditional, 65+ accelerated approvals). In Phase 3 it was about 27% more effective than a standard flu shot; it uses mRNA and can be produced in 2–3 months, but it does not protect against COVID. Younger than 50 can’t get it this season. Price is about $171 per dose without insurance, with coverage varying by insurer, and it’s rolling out to CVS/Walgreens as stock permits ahead of the October vaccination window.

via NBC News|

#fda-approval #flu-vaccine #health

health21 days ago•2 min saved

FDA approves first gene therapy for Sanfilippo syndrome, a rare childhood neurodegenerative disease

The FDA approved Ultragenyx’s gene therapy Fayuvi as the first treatment for Sanfilippo syndrome type A, a rare pediatric neurodegenerative disease, with price not disclosed.

via STAT|

#fayuvi #fda-approval #gene-therapy

health21 days ago•24 min saved

North Bay Gets Next-Gen Flu Vaccine at Local Pharmacies This Week

North Bay residents may access Moderna’s new mRNA flu vaccine, mFLUSIVA, at CVS and Walgreens this week after FDA approval for adults 50–64 and 65+, with trial data showing about 26.6% higher protection than standard flu shots across the major flu strains; the vaccine’s rapid design and three-strain target could reduce mismatches versus egg-based vaccines, though side effects are common and protection lasts roughly six months—experts also urge ongoing precautions and note some local providers are still evaluating formulary for future seasons.

via pressdemocrat.com|

#cvs #fda-approval #health

health22 days ago•11 min saved

Half of U.S. Kids Delayed for Updated Covid Vaccines Amid Delivery Hurdles

Nearly three weeks after the FDA approved updated Covid vaccines, about half of U.S. children cannot receive them because the federal government has not decided to supply doses through the Vaccines for Children program, which would provide free shots to uninsured, underinsured or Medicaid-eligible kids; those with insurance can get doses, but the program’s status delays access for many low-income families.

via The New York Times|

#covid-19 #fda-approval #health

health23 days ago•11 min saved

First FDA-approved mRNA flu vaccine targets adults 50 and older

The FDA approved Moderna’s mFLUSIVA (mRNA-1010) for adults 50+, marking the first influenza vaccine using mRNA technology. In trials it was about 26.6% more effective than traditional flu vaccines and produced a stronger immune response in adults 65+, with safety data from roughly 70,000 participants. Real-world data from the 2026–27 season will show performance in broader populations. The mRNA platform enables faster updates to match circulating strains, potentially changing regulatory and rollout dynamics, but questions remain about cost, availability, and uptake. Traditional egg-based and recombinant vaccines will remain available for now, and long-term adoption will depend on real-world effectiveness and public acceptance.

via Futurity|

#fda-approval #flu-vaccine #health

health29 days ago•6 min saved

First mRNA flu shot cleared for 50+—a faster, potentially more protective seasonal vaccine

The FDA approved Moderna’s mFLUSIVA (mRNA-1010) for adults 50 and older as the first influenza vaccine using mRNA technology, with trial data showing about 26.6% greater effectiveness than traditional flu vaccines and a stronger immune response in older adults, plus a safety profile based on roughly 70,000 participants. The mRNA platform promises faster updates to match circulating strains, which could alter regulatory and manufacturing timetables. Real‑world performance will be tested in the 2026–27 season; meanwhile, cost, access, and how widely it will be stocked or adopted remain uncertain, and traditional flu shots will continue to be available this season. Uptake may hinge on vaccine confidence in mRNA technology, and long‑term changes to vaccine recommendations could follow real‑world effectiveness data.

via Johns Hopkins University|

#fda-approval #flu-vaccine #health