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FDA

US
FDA

Apple's AirPods Pro 2 receive FDA's first-ever OTC hearing aid approval ExtremeTech08:47Apple Top Tech Brands Hearing aid

AirPods Pro hearing aid mode is good to go T303:06Apple Top Tech Brands Hearing aid

How Apple Watch sleep apnea detection works in watchOS 11 AppleInsider06:27Apple Watch Apple Top Tech Brands

The FDA just cleared Apple’s new sleep apnea detection in watchOS 11, but it doesn’t work on the first Apple Watch Ultra iDownloadBlog13:45Apple Watch Apple Top Tech Brands

Elon Musk's Neuralink gets FDA's breakthrough 'device tag' for 'Blindsight' implant News18.com00:25Neuralink Elon Musk Pharma

Elon Musk's Neuralink gets FDA breakthrough device tag for 'Blindsight' implant The Economic Times01:45Neuralink Elon Musk Pharma

Eli Lilly's eczema drug receives FDA approval one year after its initial rejection Biopharma Reporter05:22Ebglyss Eli Lilly Pharma

Lilly gets FDA approval for eczema drug Ebglyss Zacks04:05Ebglyss Eli Lilly Pharma

Novartis' Kisqali plus ET bags FDA approval for HR+/HER2- breast cancer Manufacturing Chemist05:03Novartis Breast Cancer Cancer

FDA expands approval of ribociclib to early breast cancer Medpage Today01:33Novartis Breast Cancer Cancer

Roche’s injectable PD-L1 inhibitor granted FDA approval for multiple cancer types PMLiVE07:28Roche Cancer Treatment Pharma

Roche’s injectable Ocrevus Zunovo granted FDA approval to treat relapsing and primary MS PMLiVE07:22Roche Cancer Treatment Pharma

Sanofi/Regeneron’s Dupixent granted FDA approval for adolescents with CRSwNP PMLiVE07:22Regeneron Sanofi Biotech

Regeneron’s Dupixent approved as first adolescent CRSwNP treatment Pharmaceutical Technology05:56Regeneron Sanofi Biotech

Why 3D systems (DDD) stock is trading higher Benzinga14:463D Printing Pharma

3D Systems receives FDA approval for new 3D printed surgical guides 3D Printing Industry07:263D Printing Pharma

Senseonics and Ascensia announce FDA approval for one-year CGM system Verdict Medical Devices04:15Health

FDA clears first 1-year continuous glucose monitoring system for diabetes Pharmacy Times12:03Health

FDA releases draft guidance on oncology multiregional clinical trials Clinical Trials Arena12:08Pharma Cancer Cancer Treatment

Medical devices and why cybersecurity is non-negotiable New Electronics08:51Pharma Cancer Cancer Treatment

Latest News

In the last half-hour

ImCheck Receives FDA Fast Track Designation for ICT01 in Combination with Azacitidine and Venetoclax in First-Line… GlobeNewswire (Press Release)05:07

Novartis' Kisqali plus ET bags FDA approval for HR+/HER2- breast cancer Manufacturing Chemist05:03

Neuralink’s ‘blindsight’ implant gets key FDA designation Silicon Republic05:03

In the last 2 hours

Senseonics and Ascensia announce FDA approval for one-year CGM system Verdict Medical Devices04:15

Brain implant gets FDA 'breakthrough device' label Gulf News04:02

Lilly on alert as new Kisqali approval threatens Verzenio pharmaphorum03:39

In the last 4 hours

CS Analytical Partners with Contract Laboratory to Host Webinar on Package System Regulatory… PRWeb (Press Release)03:07

Imugene gets crucial FDA nod for bile tract cancer drug The West Australian02:55

After FDA no, MSD/Daiichi post new data with lung cancer ADC pharmaphorum02:48

AstraZeneca’s Fasenra Wins FDA Approval for Rare Vasculitis TipRanks02:37

Paradigm steps closer to Phase 3 trial for knee arthritis treatment after FDA feedback Stockhead02:01

Elon Musk's Neuralink gets FDA breakthrough device tag for 'Blindsight' implant The Economic Times01:45

FDA Expands Approval of Ribociclib to Early Breast Cancer Medpage Today01:33

Eye Drop Company in FDA's Sights Once Again Medpage Today01:33

First Drug OK'd for Chronic Rhinosinusitis With Nasal Polyps in Adolescents Medpage Today01:33

Elon Musk's Neuralink gains FDA breakthrough tag for vision implant The Business Standard01:33

Earlier today

Imugene secures FDA orphan drug designation for bile tract cancer treatment Proactive Investors (US)01:21

Neuralink's vision restoration implant gets FDA approval: How 'Blindsight' works NewsBytes00:50

Elon Musk's Neuralink Gets FDA's Breakthrough 'Device Tag' For 'Blindsight' Implant News18.com00:25

In the last 6 hours

Imugene Gains FDA Orphan Status for Cancer Therapy TipRanks23:23 17-Sep-24

In the last 8 hours

Health Check: Paradigm receives FDA guidance on proposed trial for dodgy knees Stockhead22:57 17-Sep-24

Neuralink gets FDA's 'breakthrough device' tag for Blindsight implant The Japan Times22:23 17-Sep-24

Senhwa Biosciences Announces IND Submission to US FDA for Pilot Study of Pidnarulex… PR Newswire (Press Release)22:08 17-Sep-24

FDA Approves Merck’s Keytruda in Mesothelioma Treatment Bloomberg Law21:48 17-Sep-24

Yesterday

FDA backs Somite.ai's new drug for rare children's muscle disease Jerusalem Post20:49 17-Sep-24

'Could restore sight': FDA grants 'breakthrough status' to Musk’s Neuralink 'Blindsight'… The Times of India20:40 17-Sep-24

Guess which ASX biotech stock is surging 11% on big FDA news The Motley Fool (Australia)20:10 17-Sep-24

FDA Approves Pembrolizumab Plus Chemo for Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma OncLive18:50 17-Sep-24

Zelira Therapeutics Updates on FDA Progress TipRanks18:38 17-Sep-24

FDA OKs Software That Turns AirPods Pro Into a Hearing Aid PYMNTS.com18:33 17-Sep-24

FDA leery of using PCCP mechanism for special 510(k) filings BioWorld18:06 17-Sep-24

Neuralink Blindsight receives FDA Breakthrough Device Designation for visually impaired patients Shacknews17:28 17-Sep-24

Neuralink’s ‘breakthrough device’ clearance from FDA does not mean they have cured blindness TechCrunch17:22 17-Sep-24

Theratechnologies Announces a Risk of a Temporary Supply Disruption for EGRIFTA SV® in Early 2025 GlobeNewswire (Press Release)17:10 17-Sep-24

Elon Musk’s New Device, Enabling Blind People To See, Put on Fast Track by FDA The New York Sun17:10 17-Sep-24

Avoid common US import errors by vetting your filer, FDA says Verdict Medical Devices17:04 17-Sep-24

watchOS 11 is cleared by FDA to debut with Sleep Apnea alerts NotebookCheck.net16:55 17-Sep-24

Boston Scientific expands FDA label for Ingevity+ pacing leads Verdict Medical Devices16:44 17-Sep-24

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests JD Supra16:32 17-Sep-24

Elon Musk's Neuralink secures FDA breakthrough status for vision implant Proactive Investors (UK)16:29 17-Sep-24

FDA approval of new drug regimen helps reduce risk of breast cancer recurrence for patients with early-stage disease Newswise (Press Release)16:16 17-Sep-24

Rubio, King to FDA: Strengthen Our Nation’s Medical Manufacturing U.S. Senator for Florida, Marco Rubio (Press Release)15:48 17-Sep-24

FDA hopes to fight obesity with labels Salon.com15:38 17-Sep-24

FDA Approves Ribociclib for Early Breast Cancer Treatment With High Recurrence Rate American Journal of Managed Care15:36 17-Sep-24

Musk's Neuralink gets FDA's breakthrough device tag for 'Blindsight' implant Yahoo! US15:26 17-Sep-24

Musk's Neuralink receives FDA's breakthrough device tag for brain implant Channel NewsAsia15:25 17-Sep-24

Novartis heaps pressure on Lilly with broad FDA approval for Kisqali in early breast cancer FiercePharma15:22 17-Sep-24

Novartis’ Kisqali snags FDA approval to reduce recurrence in patients with early forms of breast cancer ENDPOINTS15:09 17-Sep-24

FDA expands approval of breast cancer drug Kisqali to earlier stage patients NECN, New England15:04 17-Sep-24

Conducting trials via routine clinical practice: FDA explains how in new draft guidance ENDPOINTS14:59 17-Sep-24

FDA elevates recall as Zimmer Biomet phases out hip replacement implant FierceBiotech14:47 17-Sep-24

Why 3D Systems (Ddd) Stock Is Trading Higher Benzinga14:46 17-Sep-24

FDA Roundup: September 17, 2024 PR Newswire (Press Release)14:39 17-Sep-24

Apple AirPods Pro 2 approved by FDA DevX.com14:36 17-Sep-24

Novartis Kisqali Wins FDA Approval for EBC TipRanks14:33 17-Sep-24

FDA clears Senseonic’s Eversense one-year implantable CGM BioWorld14:33 17-Sep-24

Newer Airpods Now Come With FDA-Approved Hearing Aid Feature Black Enterprise14:18 17-Sep-24

FDA Approves Ribociclib in Combination With an Aromatase Inhibitor for HR+/HER2- Early Breast Cancer Pharmacy Times14:05 17-Sep-24

FDA approves Apple Watch screening for sleep apnea risk Popular Science13:42 17-Sep-24

Alliance for Hippocratic Medicine on Remand—Still Struggling with Standing Reason13:27 17-Sep-24

FDA Approves Adjuvant Ribociclib in HR+/HER2– Breast Cancer OncLive13:15 17-Sep-24

FDA Proposes Submission Tracking Number Requirement for ENDS Imports JD Supra13:08 17-Sep-24

FDA Sampling Finds Milk in 6.2 Percent of “Dairy-Free” Chocolate Products Food Safety Magazine13:05 17-Sep-24

FDA Grants RMAT Designation to P-BCMA-ALL01 for R/R Multiple Myeloma OncLive13:04 17-Sep-24

FDA approves Novartis Kisqali® to reduce risk of recurrence in people with HR+/HER2- early breast cancer GlobeNewswire (Press Release)12:58 17-Sep-24

See-Mode Technologies gets US FDA clearance for thyroid ultrasound AI analysis and reporting software BioSpectrum Asia12:35 17-Sep-24

FDA lifts partial clinical hold on Zentalis Pharma’s cancer WEE1 inhibitor Clinical Trials Arena12:28 17-Sep-24

Playground Drops Naked Love, an FDA-Approved Lube for Sensitive Vulvas HYPEBEAST12:08 17-Sep-24

FDA releases draft guidance on oncology multiregional clinical trials Clinical Trials Arena12:08 17-Sep-24

FDA Clears First 1-Year Continuous Glucose Monitoring System for Diabetes Pharmacy Times12:03 17-Sep-24

FDA to propose new food label warnings to combat obesity FOX13 Seattle11:42 17-Sep-24

FDA clears Senseonics’ 365-day Eversense CGM implant FierceBiotech11:24 17-Sep-24

In brief: Victrex gets FDA go-ahead for knee replacement study London South East11:21 17-Sep-24

NSPR Stock Declines Despite PMA Application Submission for CGuard Zacks11:02 17-Sep-24

FDA Approves Pavblu for Retinal Conditions Center for Biosimilars10:49 17-Sep-24

25 New Beverage and Candy Companies Join ReposiTrak’s Rapidly Expanding Food Traceability… Business Wire (Press Release)10:43 17-Sep-24

FDA Authorizes First-Ever Over-the-Counter Hearing Aid Software That Works with AirPods Nerdist10:40 17-Sep-24

FDA Compounding Advisory Panel to Review Bulk Drug Substances Bloomberg Law10:36 17-Sep-24

Apple transforms AirPods Pro 2 into low-cost hearing aids Fox News10:23 17-Sep-24

New Sickle Cell Treatments Reach Patients after Years of Effort Scientific American10:21 17-Sep-24

Spectral AI preparing to seek FDA approval of DeepView burn assessment device Proactive Investors (US)09:45 17-Sep-24

Boehringer Ingelheim score with phase 3 idiopathic pulmonary fibrosis win Outsourcing-Pharma.com09:39 17-Sep-24

Zentalis Stock Up as FDA Lifts Partial Hold on Cancer Drug Studies Zacks09:30 17-Sep-24

Victrex Gains FDA Nod for PEEK Knee System Study TipRanks09:28 17-Sep-24

Zimmer Biomet CPT Hip System Femoral Stem and Increased Risk of Thigh Bone Fracture - FDA… U.S. Food and Drug Administration (Press Release)09:14 17-Sep-24

PharmaJet and Scancell Sign Strategic Partnership Agreement for Development and… Business Wire (Press Release)09:13 17-Sep-24

Experity Enhances Urgent Care Teleradiology Overread Services with FDA-approved Artificial… Business Wire (Press Release)09:03 17-Sep-24

Mitsubishi Tanabe Pharma America to Showcase RADICAVA ORS® (edaravone) Presentations at 2024… PR Newswire (Press Release)09:03 17-Sep-24

Philips announces FDA approval for enhanced LumiGuide guidewire and marks the 1000th patient treated with its… GlobeNewswire (Press Release)08:59 17-Sep-24

3D Systems Receives FDA Clearance for First-to-Market Multi-material, Monolithic Jetted Denture Solution GlobeNewswire (Press Release)08:30 17-Sep-24

BridgeBio Says FDA Grants Breakthrough Therapy Designation To Oral Infigratinib For Achondroplasia RTT News08:13 17-Sep-24

Up to One-Third of Antibody Drugs Are Nonspecific, Study Shows PR Newswire (Press Release)08:12 17-Sep-24

CAMP4 Therapeutics Secures Orphan Drug Designation for CMP-CPS-001 for the Treatment of Urea Cycle Disorders GlobeNewswire (Press Release)08:08 17-Sep-24

Moderna Admits Being ‘Overly Optimistic’ regarding Respiratory Syncytial Virus Vaccination European Pharmaceutical Manufacturer08:04 17-Sep-24

See-Mode Technologies Receives FDA Clearance for Thyroid Ultrasound AI Analysis and Reporting… PR Newswire (Press Release)08:02 17-Sep-24

Papillon Therapeutics Receives Orphan Drug Designation from the U.S. Food and Drug… Business Wire (Press Release)08:01 17-Sep-24

Atsena Therapeutics Receives Orphan Drug Designation from the U.S. FDA for ATSN-201 Gene Therapy to Treat X-linked… GlobeNewswire (Press Release)07:39 17-Sep-24

BridgeBio Announces Infigratinib Is the First Ever Investigational Therapeutic Option for Achondroplasia to Be Awarded… GlobeNewswire (Press Release)07:38 17-Sep-24

‘Unsafe’ Chinese plug-in bug repellent devices seized Bangkok Post07:23 17-Sep-24

Roche’s injectable Ocrevus Zunovo granted FDA approval to treat relapsing and primary MS PMLiVE07:22 17-Sep-24

Sanofi/Regeneron’s Dupixent granted FDA approval for adolescents with CRSwNP PMLiVE07:22 17-Sep-24

Postsurgical treatment with pembrolizumab doubles cancer-free time for bladder cancer patients News-Medical.Net07:20 17-Sep-24

Eversense 365 Receives FDA Clearance: The World’s First One Year CGM GlobeNewswire (Press Release)07:02 17-Sep-24

Boston Scientific Receives FDA Approval for Expanded Indication of INGEVITY™+ Pacing Leads to… PR Newswire (Press Release)07:01 17-Sep-24

How Apple Watch sleep apnea detection works in watchOS 11 AppleInsider06:27 17-Sep-24

Epitomee Medical receives FDA clearance for weight management capsule Verdict Medical Devices06:03 17-Sep-24

FDA clears sleep apnoea feature for new Apple Watch pharmaphorum05:48 17-Sep-24

FDA grants RMAT to Poseida’s CAR-T cell therapy P-BCMA-ALLO1 Pharmaceutical Technology05:40 17-Sep-24

Eli Lilly's eczema drug receives FDA approval one year after its initial rejection Biopharma Reporter05:22 17-Sep-24

FDA designations boost AI-driven cell therapy approach for Duchenne muscular dystrophy Biopharma Reporter05:22 17-Sep-24

AI Adds Complexities to Real-World Data in FDA Drug Approvals Bloomberg Law05:10 17-Sep-24

Lilly Gets FDA Approval for Eczema Drug Ebglyss Zacks04:05 17-Sep-24

In the last 7 days

Chemists’ association demands action against spurious, substandard drugs Hindustan Times21:56 16-Sep-24

FDA Approves Tremfya for Ulcerative Colitis HealthDay18:25 16-Sep-24

Senators send stern message to US FDA on animal testing BioWorld17:54 16-Sep-24

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18 Sep 05:07

FDA News

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