https://www.biopharmadive.com/news/fdas-rapid-review-pace-nets-an-early-approval-for-alnylams-second-drug/567754/
Givosiran, which will be sold as Givlaari, is the second RNAi therapeutic cleared by the agency after Alnylam's Onpattro.
fdarapidreviewpacenets
https://reports.statnews.com/collections/all-reports/products/speed-and-safety-fdas-drug-approval
Our latest report unpacks the differences between the different ways the FDA approves drugs, like accelerated approvals, fast-track designations, and emergency...
guidefdadrugapprovalpathways
https://newschannel20.com/news/coronavirus/covid-19-pill-paxlovid-pfizer-emergency-fda-approval-authorization-use-food-drug-administration-safe-effective-treatment-high-risk-adults
Pfizer’s COVID-19 pill Paxlovid won another vote of confidence from U.S. health advisers Thursday, clearing the way for its full regulatory approval...
high riskcovidtreatmentpaxlovidadults
https://www.wired.com/story/paradromics-gets-fda-approval-to-trial-its-brain-implant-in-people/
Nov 20, 2025 - The Austin-based startup will test its high-bandwidth device to help restore speech in people with extremely limited movement.
fda approvalgetstrialbrainimplant
https://katiecouric.com/health/hra-pharma-otc-birth-control/
Apr 25, 2025 - In what would mark a first for the U.S., a drugmaker is asking the FDA to approve an over-the-counter birth control.
fda approvalhrapharmaseekscounter
https://www.yahoo.com/news/articles/fda-approval-wegovy-pill-era-231758718.html
Dec 22, 2025 - With FDA approval of Wegovy pill, new era of oral GLP-1 weight loss drugs begins
fda approvalwegovy pillnew eraoral
https://www.biopharmadive.com/news/novo-nordisk-rybelsus-fda-approval-first-line-diabetes/640376/
The approval could help Rybelsus compete with oral drugs marketed by Eli Lilly, Merck & Co. and others.
novo nordiskfda approvalfirst linediabetespill
https://www.verywellmind.com/fda-approval-and-mental-health-apps-5193123
Learn about which apps are FDA approved for mental health treatment and how an app gets FDA approval.
mental health appsfda approval
https://www.nsmedicaldevices.com/news/dentalmonitoring-gets-fda-de-novo-approval-for-remote-monitoring-software/
May 21, 2024 - DentalMonitoring has been granted De Novo approval by the US FDA for its DentalMonitoring remote monitoring solution.
remote monitoringgetsfdadenovo
https://med.stanford.edu/news/all-news/2025/08/blood-cancer-drug.html
Fewer than half of people diagnosed with a subtype of myeloid/lymphoid neoplasms are alive one year later. A multicenter Phase 2 trial led by Stanford Medicine...
stanford medicinefda approvalledtrialleads
https://ir.lenz-tx.com/news-events/press-releases/detail/39/lenz-therapeutics-announces-us-fda-approval-of-vizz-for-the-treatment-of-presbyopia
VIZZ is the first and only aceclidine-based eye drop approved to improve near vision in adults with presbyopia, a condition impacting…...
fda approvallenztherapeuticsannouncesus
https://www.medtechdive.com/news/Medtronic-Hugo-FDA-submission-urology/746489/
William Blair analyst Brandon Vazquez said 2025 could be the first year market leader Intuitive Surgical will face meaningful U.S. competition.
fda approvalmedtronicsubmitshugosoft
https://www.citygatenetwork.org/opioid-overdose-treatment-gets-fda-approval/
Sep 12, 2025 - The Food and Drug Administration (FDA) approved an over-the-counter version of naloxone, the opioid overdose reversal drug previously available only as a...
opioid overdosefda approvaltreatmentgetsnetwork
https://medcloudinsider.com/blogs/medcloud-minute/2025/09/medtronic-wins-fda-approval-for-altaviva-urinary-incontinence-device.aspx
New implantable system offers a simplified therapy option for patients with urge urinary incontinence.
fda approvalurinary incontinencemedtronicwinsdevice
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-carvykti-ciltacabtagene-autoleucel-treatment-adult-patients
Listen to a soundcast of the 2/28/2022 FDA approval of CARVYKTI (ciltacabtagene autoleucel) for the treatment of adults with relapsed or refractory multiple...
fdacbursteditionapproval
https://medcloudinsider.com/blogs/medcloud-minute/2025/10/nobles-medical-gains-fda-approval.aspx
Device aims to provide a suture-based alternative for heart defect closure without implanted metal.
fda approvalclinical trialnoblesmedicalgains
https://www.biopharmadive.com/news/FDA-approve-velsipity-etrasimod-ulcerative-colitis-pfizer/696551/
Acquired with the buyout of Arena Pharmaceuticals, Velsipity enters a competitive market for ulcerative colitis pills.
fda approvalpfizerwinscolitisdrug
https://www.medtechdive.com/news/cook-medical-aortic-dissection-device-gets-fda-approval/547679/
The device is designed to repair Type B dissections of the descending thoracic aorta in a minimally invasive procedure.
aortic dissectionfda approvalmedtech divecookmedical
https://beststartup.us/vizz-eye-drops-fda-approval-for-presbyopia/
Nov 26, 2025 - VIZZ Eye Drops Pillar Article VIZZ Eye Drops by LENZ Therapeutics: Transforming Near Vision Care for Adults Discover a new option for ad
eye dropsfda approvalvizzpresbyopiatreatment
https://bigthink.com/the-present/inside-the-battle-for-fda-approval-of-mdma-therapy/
MAPS founder Rick Doblin speaks to Big Think about the FDA’s rejection of MDMA therapy and the future of psychedelic treatments.
fda approvalinsidebattlemdmatherapy
https://endpoints.news/dyne-says-duchenne-drug-succeeds-in-pivotal-study-heads-to-fda-for-approval/
Dec 8, 2025 - Dyne Therapeutics announced Monday that its Duchenne muscular dystrophy drug z-rostudirsen hit the primary endpoint in a key study and plans to take the...
saysdrugsucceedspivotalstudy
https://newatlas.com/medical-devices/human-trial-experimental-brain-chip-connexus/
Nov 21, 2025 - Paradromics gets FDA approval for its Connexus BCI human trial, aiming to restore speech and computer control for people with severe paralysis.
fda approvalbcitrialrestorespeech
https://clarivate.com/podcasts/ideas-to-innovation-season-three/pioneering-paths-the-tarpeyo-journey-to-fda-approval-and-beyond/
The remarkable journey of Calliditas Therapeutics and its groundbreaking drug, Tarpeyo, sheds light on the company’s innovative strategies and relentless
fda approvalpioneeringpathsjourneybeyond
https://www.cstoredive.com/news/njoy-fda-ace-2-vaping-device-flavored-pods/716798/
The new Njoy Ace 2.0 uses bluetooth technology to limit underage use.
fda approvalnjoyseeksnewvaping
https://www.hpnonline.com/regulatory/news/55327033/fda-announces-faster-approval-pathway-for-biosimilar-medicines
Biosimilar medicines are lower-cast generic alternatives to biologic drugs, and 76 have been approved since a pathway was set up in 2010.
fdaannouncesfasterapprovalpathway
https://www.medicaldevice-developments.com/news/zimmer-biomet-secures-fda-approval-for-rosa-knee-with-optimize-system/
Nov 17, 2025 - Zimmer Biomet has received 510(k) clearance from the US Food and Drug Administration (FDA) for ROSA Knee with OptimiZe technology.
zimmer biometfda approvalgetsrosaknee
https://www.nsmedicaldevices.com/news/orthofix-fda-approval-rodeo-telescopic-nail/
May 10, 2024 - US-based Orthofix Medical has received the US Food and Drug Administration (FDA) 510(k) approval to market its Rodeo Telescopic Nail.
securesfdakapprovalrodeo
https://international.cliniexperts.com/premarket-approval-process/
Sep 10, 2024 - Explore the critical stages in the FDA's Premarket Approval (PMA) process, including requirements and key strategies for a successful medical device...
navigatingfdapremarketapprovalpma
https://www.scientificamerican.com/article/a-psychedelic-may-soon-go-to-the-fda-for-approval-to-treat-trauma/
Feb 20, 2024 - MDMA, known as Ecstasy in the clubs, gained high marks in a clinical trial for PTSD
psychedelicmaysoongofda
https://www.greenstate.com/psychedelics/lsd-fda-approval-trial/
Jun 20, 2024 - Pharmaceutical company MindMed has announced updates on its clinical trial, with its LSD compound getting closer to FDA approval.
fda approvallsdinchescloser
https://www.merck-animal-health.com/blog/2025/07/18/merck-animal-health-announces-fda-approval-of-exzolt-fluralaner-oral-solution-for-chickens-to-treat-and-control-northern-fowl-mites/
Jul 18, 2025 - Today we announced the U.S. Food and Drug Administration (FDA) approval of EXZOLT™, a parasiticide for chickens that treats and controls northern fowl mites...
animal healthfda approvalmerckannouncesoral
https://www.thehindu.com/sci-tech/health/agios-pharma-shares-jump-as-us-fda-expands-approval-for-blood-disorder-drug/article70473247.ece
Agios Pharma's shares soar 16% after FDA expands approval for its blood disorder drug, Aqvesme, set for late next month.
pharmasharesjumpfdaexpands
https://endpoints.news/otsukas-anti-april-antibody-gets-fda-approval-for-kidney-disease-igan/
Nov 26, 2025 - Otsuka secured FDA accelerated approval for its antibody drug in a disease that impacts the kidneys’ ability to filter waste.
fda approvalkidney diseaseantiaprilgets
https://www.devicetalks.com/diabetes-business-on-fast-track-after-fda-approval-of-minimed-780g-system-warning-letter-resolution/
May 31, 2023 - Join Que Dallara, President of the Diabetes Business at Medtronic, as she discusses the company's comprehensive diabetes portfolio, the transformative...
fast trackfda approvaldiabetesbusiness
https://www.statnews.com/2025/12/19/cytokinetics-heart-drug-myqorzo-fda-approval/
Dec 19, 2025 - The Food and Drug Administration's clearance of Myqorzo ends one of the longest R&D droughts in the biotech industry.
fda approvalheartdrugwinsbiotech
https://www.pharmavoice.com/news/ultra-rare-disease-fda-stealth-biotherapeutics-drug-pharma/802757/
Stealth BioTherapeutics’ FDA win could help build momentum in the broader rare disease space.
rare diseasesfda approvalultragotboost
https://www.techtarget.com/pharmalifesciences/feature/GLP-1-drugs-primed-for-FDA-approval-in-2026
Jan 7, 2026 - With Pharma titans Eli Lilly and Novo Nordisk continuing to duke it out over control of the GLP-1 market, both are seeking FDA approval for new drugs this year.
fda approvalglpdrugstechtarget
https://news.abbvie.com/2024-10-18-BOTOX-R-Cosmetic-onabotulinumtoxinA-Receives-FDA-Approval-for-Moderate-to-Severe-Vertical-Bands-Connecting-the-Jaw-and-Neck-Platysma-Bands
The Only Product of Its Kind Approved for Use in Four Aesthetic Indications: Temporary Improvement in the Appearance of Moderate to Severe Forehead Lines,...
fda approvalcosmeticreceivesmoderatesevere
https://www.buzzfeednews.com/article/juliareinstein/federal-judge-mifepristone-abortion-drug-ruling
Apr 10, 2023 - It wasn’t immediately clear what the dueling opinions will mean for access to medication abortion. The conflict “almost guarantees that the Supreme Court...
fda approvalabortion pillfederaljudgesuspends
https://njbmagazine.com/njb-news-now/novartis-receives-fda-approval-for-spinal-muscular-atrophy-gene-replacement-therapy/
Nov 26, 2025 - The FDA has approved Itvisma for the treatment of children two years and older, teens and adults living with spinal muscular atrophy
spinal muscular atrophyfda approvalnovartisreceivesgene
https://www.statnews.com/2025/09/25/new-acromegaly-drug-fda-approves-palsonify-crinetics-pharmaceuticals/
Sep 25, 2025 - Crinetics Pharmaceuticals, a San Diego biotech with $3.2 billion market cap, tested 807 molecules on its way to developing this daily pill
fda approvalnewdrugwinsstat
https://www.prnewswire.com/news-releases/johnson--johnson-receives-fda-approval-for-trufill-nbca-liquid-embolic-system-for-the-treatment-of-symptomatic-chronic-subdural-hematoma-302645188.html
/PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) – Today, Johnson & Johnson MedTech, a leader in neurovascular care, announced that the U.S. Food and...
fda approvaljohnsonampreceivesliquid
https://www.beneo.com/news/exclusive-prebiotic-claim-in-thailand
Sep 18, 2025 - BENEO secures Thai FDA’s first-ever approval for an exclusive prebiotic claim, highlighting Orafti® Inulin’s proven digestive health benefits.
fda approvalwinsthaiprebioticclaim
https://www.biopharmadive.com/news/global-blood-fda-approval-voxelotor-oxbryta/568039/
A list price of roughly $10,000 a month puts Global Blood's Oxbryta slightly higher than what Novartis' Adakveo will cost.
sickle cellfda approvalglobalblooddrug
https://www.everydayhealth.com/weight-management/first-glp-1-pill-for-weight-loss-gets-fda-approval/
Dec 23, 2025 - This new pill contains the same active ingredient as injectable Wegovy and Ozempic, semaglutide. It is the first GLP-1 pill approved for losing excess weight.
wegovy pillfda approvalwinsfirstglp
https://www.emarketer.com/content/novo-aims-stronger-wegovy-dose-rival-lilly-s-zepbound
Nov 26, 2025 - Novo Nordisk has applied for approval of a higher-dose version of its weight loss drug Wegovy using a special FDA review pathway for a faster decision....
fda approvalnovoseeksspeedyhigher
https://cardinalpine.com/2023/07/13/first-over-the-counter-birth-control-pill-gets-fda-approval/
May 14, 2024 - Opill is the first ever birth control pill to be approved for over-the-counter sales. The medication will likely become available at stores and online...
birth controlfda approvalfirstcounterpill
https://www.expresshealthcare.in/news/asahi-kasei-receives-fda-approval-for-zolls-zenix-defibrillator/451072/
Asahi Kasei has advanced its suite of critical care products through premarket approval by the U.S. Food and Drug Administration (FDA) for ZOLL’s Zenix...
fda approvalasahikaseireceivesdefibrillator
https://www.biopharmadive.com/news/novocure-fda-lung-cancer-approval-optune-lua-tumor-treating-field/729997/
Alongside immunotherapy or chemo, the wearable device helped patients live longer in a trial, though the results are somewhat controversial.
fda approvalwinselectricfielddevice
https://www.drugdiscoverytrends.com/fda-gives-double-approval-of-lung-cancer-diagnostic-and-treatment/
Oct 22, 2025 - The FDA has announced a landmark double approval of a new diagnostic tool and treatment for lung cancer. Discover what this means for patients and the future...
lung cancerfdagrantsdoubleapproval