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Fda Approval

All articles tagged with #fda approval

health2 days ago•6 min saved

FDA approves Moderna’s first mRNA flu shot for adults 50+, enabling faster strain matching

The FDA approved Moderna’s mFLUSIVA (mRNA-1010), the first mRNA-based seasonal flu vaccine, for adults 50 and older, based on phase 3 data showing superior protection against flu-like illness versus standard vaccines; accelerated approval for 65+, with post‑approval confirmatory data required. The vaccine can be produced more quickly to better match evolving influenza strains, potentially adding an important option without replacing existing vaccines; common vaccine side effects apply, and availability is anticipated for the 2026–2027 season.

via Medical News Today|

#fda-approval #health #influenza-vaccine

health4 days ago•4 min saved

Personalized mRNA Melanoma Vaccine Extends Recurrence-Free Survival in Phase 3

Moderna and Merck reported Phase 3 results for intismeran autogene (a personalized mRNA cancer vaccine) combined with Keytruda in high-risk melanoma patients after surgery, showing longer recurrence-free and metastasis-free survival versus Keytruda alone; safety was consistent with prior data. If confirmed, the vaccine could reshape cancer prevention and treatment and bolster mRNA vaccine credibility, but overall survival results and external validation are still pending.

via Gizmodo|

#cancer-immunotherapy #clinical-trials #fda-approval

health5 days ago•7 min saved

Fall Vaccine Update: Updated Flu and COVID Shots Are Coming With Coverage

Fall will bring updated influenza and COVID-19 vaccines, with insurers expected to cover them despite ongoing uncertainty from federal guidance; major medical societies are urging routine vaccination for all 6 months and older (flu) and for high-risk groups for COVID, and the FDA has approved an mRNA flu shot (mFlusiva) for ages 50–64 that will roll out through pharmacies, though it may take time to become widely available. Annual vaccination is recommended due to yearly viral mutation and waning protection.

via CIDRAP|

#acip-guidance #covid-19-vaccine #fda-approval

health10 days ago•9 min saved

FDA approves first mRNA flu shot for adults 50+, aiming for better strain matching

FDA approves Moderna’s mRNA-based flu vaccine, mFlusiva, for adults 50 and older (standard approval for ages 50–64 and accelerated approval for 65+), leveraging faster manufacturing to allow strain updates closer to the season. In a large trial, it was about 27% more effective than standard flu shots in people over 50 but had more mild to moderate side effects; serious events were similar to other vaccines. A post-marketing study is required, and availability may be limited this fall while a CDC recommendation is pending due to a delay in the ACIP meeting. Insurance coverage remains uncertain until guidelines are issued. The vaccine could be a valuable option for an older population at higher risk of severe flu outcomes.

via CNN|

#fda-approval #flu-vaccine #health

health10 days ago•2 min saved

FDA approves Zenbexus, first-in-class therapy for advanced multiple myeloma

The FDA approved Bristol Myers Squibb's oral iberdomide (Zenbexus) for advanced multiple myeloma in combination with Darzalex and dexamethasone, marking the debut of a new drug class and the use of a more sensitive measure of cancer remission.

via statnews.com|

#fda-approval #health #iberdomide

health11 days ago•9 min saved

FDA approves first mRNA flu vaccine for adults 50+, aiming for better strain matching

FDA approves Moderna’s mFlusiva, the first mRNA-based flu vaccine, for adults 50+, with standard approval for 50–64 and accelerated approval for 65+, enabling faster production and closer strain matching; in a 40,000+ participant trial it was about 27% more effective than standard vaccines for ages 50+, though with more transient side effects; a post-marketing study is required, rollout may be limited this fall, and insurance coverage remains unclear until ACIP weighs in (scheduled for October).

via CNN|

#fda-approval #flu-vaccine #health

healthcare11 days ago•2 min saved

Zipalertinib combo shows first-line promise in EGFR exon 20 NSCLC

Taiho and Cullinan reported that adding zipalertinib to platinum-based chemotherapy significantly extended progression-free survival versus chemotherapy alone in untreated NSCLC with EGFR exon 20 insertion, meeting the primary endpoint and prompting unblinding. The partners plan to pursue FDA first-line approval, complementing an FDA-accepted path for second-line use. If approved, zipalertinib would join a competitive landscape featuring J&J’s Rybrevant and AstraZeneca’s Zegfrovy in the EGFR exon 20 NSCLC niche.

via Fierce Biotech|

#egfr-exon-20-insertion #fda-approval #first-line-therapy

science11 days ago•6 min saved

Moderna’s mRNA flu vaccine cleared for older adults, promising faster strain updates

The FDA approved Moderna’s mRNA flu vaccine, mFLUSIVA, for adults 50–64 and gave accelerated approval for adults 65+, with the potential to rapidly reformulate to match circulating influenza strains. In trials, it showed a 26.6% relative reduction in lab-confirmed flu versus standard vaccines and was generally well tolerated, though side effects were more common. Regulators in the EU, Canada, and Australia are reviewing similar uses, and a Phase IV trial is planned to assess efficacy against an enhanced 65+ vaccine. Separately, Europe has approved a combined influenza and COVID-19 mRNA vaccine (mCombriax). Experts say the technology could improve responsiveness to evolving flu strains and ease manufacturing bottlenecks, but real-world effectiveness will determine its ultimate impact.

via Nature|

#fda-approval #influenza #mflusiva

health13 days ago•6 min saved

Ten-Second Treatment Shows Promise to Stop Cavities in Young Children

An 830-child US trial finds silver diamine fluoride can halt decay in children aged 1–6 with a 10-second application, arresting decay in 54% of treated baby teeth at six months (vs 22.5% with placebo); while not yet FDA-approved for kids, SDF could broaden access to care, including in medical settings, though it permanently stains treated teeth and more safety data are needed for permanent teeth.

via ScienceAlert|

#clinical-trial #fda-approval #health

health13 days ago•17 min saved

Promising KRAS-targeting drug daraxonrasib doubles survival in late-stage pancreatic cancer

Daraxonrasib, a KRAS-targeting drug for stage 4 pancreatic cancer, doubled survival in trials (6.7 to 13.2 months) and is being provided through an Extended Access Program ahead of FDA approval; nine Intermountain Health patients are enrolled. It is not a cure and carries side effects like rash, diarrhea, and mouth sores.

via ksl.com|

#daraxonrasib #extended-access-program #fda-approval

health13 days ago•3 min saved

Daraxonrasib Goes to Patients Early Through Expanded Access Ahead of FDA Decision

Following dramatic RASolute 302 results, physicians nationwide are offering the oral RAS inhibitor daraxonrasib to patients under expanded-access programs before FDA approval. The drug nearly doubled median overall survival in previously treated metastatic pancreatic cancer (6.7 to 13.2 months) and Revolution Medicines has filed for FDA approval. More than 2,000 patients are on EAP, with sites across the U.S.; institutions cover IRB and safety monitoring costs. Huntsman Cancer Institute reported about 50 patients through its EAP; setup takes 2–3 weeks and delivery occurs in about 7–10 days after consent. Side effects include skin toxicity, managed with dermatology input and topical/doxycycline. Trials continue in first-line metastatic pancreatic cancer, post-surgery settings, and second-line RAS-mutant NSCLC.

via Medscape|

#daraxonrasib #expanded-access-program #fda-approval

technology14 days ago•8 min saved

Samsung brings FDA-approved hearing aid to select Galaxy Buds Pro models

Samsung announced FDA-approved Hearing Aid support for the Galaxy Buds 4 Pro and Buds 3 Pro, including a Hearing Test with an audiogram in the Galaxy Health app; the feature amplifies sounds for mild to moderate hearing loss and will roll out to US and select markets in Q4 2026, not immediately available on all Buds models.

via PhoneArena|

#fda-approval #galaxy-buds-3-pro #galaxy-buds-4-pro

future-perfect16 days ago•28 min saved

First US mRNA flu vaccine signals a new era for vaccines

FDA approves mFLUSIVA, the United States’ first mRNA influenza vaccine, marking a milestone for the platform after a year of funding reversals; unlike egg-based vaccines, it can be updated in two to three months and deployed closer to flu season, hinting at future breakthroughs across vaccines and therapies, though real-world uptake will depend on access, cost, and regulatory guidance.

via vox.com|

#fda-approval #flu-vaccine #future-perfect

health17 days ago•5 min saved

mFlusiva: New mRNA flu shot outperforms traditional vaccines, but uptake may lag

FDA-approved Moderna’s mFlusiva for adults 50+ after a large study in adults aged 50-64 showed it’s about 26.6% more effective than traditional flu vaccines; approval for 65+ is provisional pending more data. Experts say it could better match circulating strains and save lives, but public concerns about mRNA and misinformation may hinder uptake, particularly on Long Island where flu vaccination rates hover around 48%.

via Newsday|

#fda-approval #flu-vaccine #health

biotech-and-pharma17 days ago•3 min saved

Replimune Wins FDA Nod for Tudriqev After Roller-Coaster Run, Shares Dip

Replimune secures FDA clearance for Tudriqev, used with Opdivo to treat advanced melanoma, on its third submission after two prior denials. The approval, supported by an advisory panel’s positive vote, sets up the company for its first commercial launch, though the stock fell about 6% as investors weighed execution risk and the company’s regulatory history. Initial rollout targets ~200 early-adopter hospital accounts with full launch expected over the next year, and analysts see significant upside if Tudriqev captures a meaningful share of refractory melanoma—potentially $1B+ in annual sales—despite launch challenges and competition from Amgen and Iovance Biotherapeutics.

via Barron's|

#biotech #biotech-and-pharma #fda-approval