"FDA" の関連情報検索結果
How two top FDA officials are quietly upending vaccine regulations - statnews.com

How two top FDA officials are quietly upending vaccine regulations statnews.com
FDA chiefs offer roadmap to expand custom gene-editing treatments like Baby KJ’s - statnews.com

FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths - Yahoo Finance

FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths Yahoo Finance
FDA restricts Sarepta's gene therapy Elevidys after Duchenne patient deaths - Fierce Pharma

FDA restricts Sarepta's gene therapy Elevidys after Duchenne patient deaths Fierce Pharma
Sarepta Announces FDA’s Approval of Updated ELEVIDYS Prescribing Information - Sarepta Therapeutics

Sarepta Announces FDA’s Approval of Updated ELEVIDYS Prescribing Information Sarepta Therapeutics
FDA's plan to boost cheaper copycat drugs could stall at the patent office - CBS News

FDA's plan to boost cheaper copycat drugs could stall at the patent office CBS News
The FDA's self-fulfilling prophecy trap - Axios

F.D.A. Names Agency Veteran to Run Drug Division - The New York Times

US FDA approves Kura-Kyowa's blood cancer therapy - Reuters

Kura and Kyowa Kirin secure FDA go-ahead for targeted leukaemia therapy - Yahoo Finance

Kura and Kyowa Kirin secure FDA go-ahead for targeted leukaemia therapy Yahoo Finance
FDA approves Kura and Kyowa Kirin’s drug for form of acute myeloid leukemia - Endpoints News

FDA approves Kura and Kyowa Kirin’s drug for form of acute myeloid leukemia Endpoints News
Opinion: How the FDA Is Accelerating Cell and Gene Therapy’s Next Chapter - BioSpace

Opinion: How the FDA Is Accelerating Cell and Gene Therapy’s Next Chapter BioSpace
Americans are injecting themselves with unproven peptides sold by influencers and RFK Jr. allies ...

Americans are injecting themselves with unproven peptides sold by influencers and RFK Jr. allies abcnews.go.com
Opinion | What Comes After the FDA’s Drug Monopoly? - The Wall Street Journal

Opinion | What Comes After the FDA’s Drug Monopoly? The Wall Street Journal
Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) - fda.gov

Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) fda.gov
US FDA adds strongest warning to Sarepta's Elevidys after fatal liver injuries - Reuters

US FDA adds strongest warning to Sarepta's Elevidys after fatal liver injuries Reuters
What the shutdown’s end means for FDA - Politico

FDA Adds Boxed Warning, Narrows Indication for Delandistrogene Moxeparvovec-rokl in DMD - Neurolo...

FDA Adds Boxed Warning, Narrows Indication for Delandistrogene Moxeparvovec-rokl in DMD Neurology Live
ACLU Files Lawsuit to Demand Transparency from the FDA in Its Review of Medication Abortion Regul...

ACLU Files Lawsuit to Demand Transparency from the FDA in Its Review of Medication Abortion Regulations American Civil Liberties Union
Rick Pazdur’s CDER appointment comes at exactly the right moment for FDA - The Cancer Letter

Rick Pazdur’s CDER appointment comes at exactly the right moment for FDA The Cancer Letter
FDA Accepts NDA for 177Lu-edotreotide in GEP-NETs - Targeted Oncology

FDA Accepts NDA for 177Lu-edotreotide in GEP-NETs Targeted Oncology
FDA Clears BrainsWay’s TMS Device for Adolescents with MDD Aged 15 to 21 Years - HCPLive

FDA Clears BrainsWay’s TMS Device for Adolescents with MDD Aged 15 to 21 Years HCPLive
Dr Richard Pazdur Appointed to Lead FDA’s Drug Division After Turbulent Year - Dermatology Advisor

Dr Richard Pazdur Appointed to Lead FDA’s Drug Division After Turbulent Year Dermatology Advisor
FDA adds strongest warning to Sarepta gene therapy for Duchenne’s linked to 2 patient deaths - WLWT

FDA adds strongest warning to Sarepta gene therapy for Duchenne’s linked to 2 patient deaths WLWT
FDA Grants Fast Track Designation to FOG-001 for Desmoid Tumors - OncLive

FDA Grants Fast Track Designation to FOG-001 for Desmoid Tumors OncLive
How Scholar Rock’s (SRRK) FDA Progress and Apitegromab Plans Have Changed Its Investment Story - ...

How Scholar Rock’s (SRRK) FDA Progress and Apitegromab Plans Have Changed Its Investment Story Yahoo Finance
FDA Approves Pertuzumab Biosimilar (Poherdy) for HER2-Positive Breast Cancer - Oncology News Central

FDA Approves Pertuzumab Biosimilar (Poherdy) for HER2-Positive Breast Cancer Oncology News Central
AVZO-1418/DB-1418 Earns FDA Fast Track Designation For EGFR-Mutated NSCLC - CancerNetwork

AVZO-1418/DB-1418 Earns FDA Fast Track Designation For EGFR-Mutated NSCLC CancerNetwork
ByHeart Broadens Voluntary Recall While Investigation Continues - fda.gov

ByHeart Broadens Voluntary Recall While Investigation Continues fda.gov
FDA Authorizes EXENT System to Aid Myeloma Diagnosis - Targeted Oncology

FDA Authorizes EXENT System to Aid Myeloma Diagnosis Targeted Oncology
FDA Accepts New Drug Application for 177Lu-Edotreotide in GEP-NETs - CancerNetwork

FDA Accepts New Drug Application for 177Lu-Edotreotide in GEP-NETs CancerNetwork
5 FDA approved drugs for GI Cancers in the first of half 2025 - Oncodaily

5 FDA approved drugs for GI Cancers in the first of half 2025 Oncodaily
Onshoring and data ‘fidelity’: What FDA wants from generic drug user fee talks - Endpoints News

Onshoring and data ‘fidelity’: What FDA wants from generic drug user fee talks Endpoints News
FDA Fast Tracks FOG-001 After Early Tumor Shrinkage in Desmoid Tumors - Cure Today

FDA Fast Tracks FOG-001 After Early Tumor Shrinkage in Desmoid Tumors Cure Today
FDA updates Elevidys labeling with boxed warning and revised indication following reports of fata...

FDA updates Elevidys labeling with boxed warning and revised indication following reports of fatal liver injury Contemporary Pediatrics
FDA Clears Magnetic Stimulation Device for Chronic Pain - Pain Medicine News

FDA Clears Magnetic Stimulation Device for Chronic Pain Pain Medicine News
FDA to drop 'black box' warnings from menopause hormone therapy - MSNBC News

FDA to drop 'black box' warnings from menopause hormone therapy MSNBC News
FDA Requests Removal of Boxed Warnings for Menopausal Hormone Therapy - Rheumatology Advisor

FDA Requests Removal of Boxed Warnings for Menopausal Hormone Therapy Rheumatology Advisor
Kura and Kyowa Kirin secure FDA go-ahead for targeted leukaemia therapy - Pharmaceutical Technology

Kura and Kyowa Kirin secure FDA go-ahead for targeted leukaemia therapy Pharmaceutical Technology
FDA Clears Deep Transcranial Magnetic Stimulation for Adolescents With MDD - Psychiatric Times

FDA Clears Deep Transcranial Magnetic Stimulation for Adolescents With MDD Psychiatric Times
FDA Approves New Interchangeable Biosimilar to Pertuzumab - The ASCO Post

FDA Approves New Interchangeable Biosimilar to Pertuzumab The ASCO Post
Outbreak Investigation of Salmonella: Moringa Leaf Powder (October 2025) - fda.gov

Outbreak Investigation of Salmonella: Moringa Leaf Powder (October 2025) fda.gov
Zimmer Biomet Receives U.S. FDA Clearance for Enhanced Version of ROSA® Knee Robotic Technology -...

Zimmer Biomet Receives U.S. FDA Clearance for Enhanced Version of ROSA® Knee Robotic Technology PR Newswire
New FDA Director Could Sway Biotech ETFs - ETF Trends

New FDA Director Could Sway Biotech ETFs ETF Trends
Sarepta’s Elevidys to Remain on Market With New FDA Warning - Bloomberg.com

Sarepta’s Elevidys to Remain on Market With New FDA Warning Bloomberg.com
Why the F.D.A.’s Latest Fluoride Move Has Doctors Worried - The New York Times

Why the F.D.A.’s Latest Fluoride Move Has Doctors Worried The New York Times
First Pertuzumab Biosimilar Earns FDA Nod for Breast Cancer - Medscape

First Pertuzumab Biosimilar Earns FDA Nod for Breast Cancer Medscape
FDA Lifts Major Warnings on Hormone Replacement Therapy - Dermatology Advisor

FDA Lifts Major Warnings on Hormone Replacement Therapy Dermatology Advisor
Organon and Henlius' Poherdy, first biosimilar to Roche's Perjeta, scores FDA nod - Fierce Pharma

Organon and Henlius' Poherdy, first biosimilar to Roche's Perjeta, scores FDA nod Fierce Pharma
FDA Issues Warning to Over a Dozen Companies Selling Counterfeit Botox — Including Several in the...

Philips to Showcase Newly FDA-Cleared Cardiovascular Workspace at RSNA - diagnosticimaging.com

Philips to Showcase Newly FDA-Cleared Cardiovascular Workspace at RSNA diagnosticimaging.com
Sarepta stock rises after FDA adds safety warning but maintains approval - Investing.com

Sarepta stock rises after FDA adds safety warning but maintains approval Investing.com
FDA-approved blood test provides simpler option for colon cancer screening - WRAL

FDA-approved blood test provides simpler option for colon cancer screening WRAL
FDA versus viral ads: what influencers can and can’t say about health claims - The Johns Hopkins ...

FDA versus viral ads: what influencers can and can’t say about health claims The Johns Hopkins News-Letter
FDA approves Poherdy, first biosimilar of Perjeta, to treat HER-positive breast cancer - Managed ...

FDA approves Poherdy, first biosimilar of Perjeta, to treat HER-positive breast cancer Managed Healthcare Executive
Outlook Therapeutics’ biologics license application for bevacizumab accepted by FDA - ROI-NJ

Outlook Therapeutics’ biologics license application for bevacizumab accepted by FDA ROI-NJ
Geneventiv notes FDA ‘positive’ feedback on hemophilia A therapy - Hemophilia News Today

Geneventiv notes FDA ‘positive’ feedback on hemophilia A therapy Hemophilia News Today
F.D.A. Sharply Limits Approval for Drug Linked to Two Teen Deaths - The New York Times

F.D.A. Sharply Limits Approval for Drug Linked to Two Teen Deaths The New York Times
Rapid Nexus wins FDA Clearance for first device targeting root causes of chronic wounds - Medical...

Rapid Nexus wins FDA Clearance for first device targeting root causes of chronic wounds Medical Economics
F.D.A. Will Remove Black Box Warnings From Hormone Treatments for Menopause - The New York Times

F.D.A. Will Remove Black Box Warnings From Hormone Treatments for Menopause The New York Times
Komzifti Gains FDA Approval, Giving Kura Oncology and Kyowa Kirin a Key Strategic Win in NPM1-Mut...

Komzifti Gains FDA Approval, Giving Kura Oncology and Kyowa Kirin a Key Strategic Win in NPM1-Mutated AML Pharmaceutical Executive
FDA Unwraps ‘Plausible Mechanism Pathway’ for Personalized Therapies - BioSpace

FDA Unwraps ‘Plausible Mechanism Pathway’ for Personalized Therapies BioSpace
FDA recalls moringa leaf powder products amid salmonella outbreak - USA Today

FDA recalls moringa leaf powder products amid salmonella outbreak USA Today
FDA Announces Recall of More Greens Powders Linked to Ongoing Salmonella Outbreak - health.com

FDA Announces Recall of More Greens Powders Linked to Ongoing Salmonella Outbreak health.com
FDA clears enhanced version of Zimmer Biomet Rosa Knee surgical robot system - MassDevice

FDA clears enhanced version of Zimmer Biomet Rosa Knee surgical robot system MassDevice
FDA clears new cloud enabled Philips cardiovascular IT system - Cardiovascular Business

FDA clears new cloud enabled Philips cardiovascular IT system Cardiovascular Business
Moonlight Companies Voluntarily Recalls California-Grown Conventional Yellow and White Peaches Be...

FDA recalls commonly prescribed ADHD medication over failed lab tests - Syracuse.com

FDA recalls commonly prescribed ADHD medication over failed lab tests Syracuse.com
Captiva Spine Announces FDA Clearance for Flat-Panel C-Arm Image Calibrators and AI-Assisted Regi...

Press Release: FDA Approves First Treatment for Barth Syndrome Following Initiative by Congresswo...

Press Release: FDA Approves First Treatment for Barth Syndrome Following Initiative by Congresswoman Kat Cammack Quiver Quantitative
AACR Welcomes the 2025–2026 FDA–AACR Oncology Educational Fellows - Oncodaily

AACR Welcomes the 2025–2026 FDA–AACR Oncology Educational Fellows Oncodaily
Zimmer Biomet Receives U.S. FDA Clearance for Enhanced Version of ROSA® Knee Robotic Technology -...

Zimmer Biomet Receives U.S. FDA Clearance for Enhanced Version of ROSA® Knee Robotic Technology Morningstar
New FDA-approved eye drop aims to help adults with age-related vision issues - CBS News

New FDA-approved eye drop aims to help adults with age-related vision issues CBS News
Stereotaxis receives FDA clearance for robotic surgical device - The Business Journals

Stereotaxis receives FDA clearance for robotic surgical device The Business Journals
Now the FDA Wants Nalmefene to Be a Fentanyl-Exposure “Prophylactic" - Filter

Now the FDA Wants Nalmefene to Be a Fentanyl-Exposure “Prophylactic" Filter
Zap-Axon radiosurgery planning system receives US FDA 510(k) and European CE-mark clearance - Neu...

Zap-Axon radiosurgery planning system receives US FDA 510(k) and European CE-mark clearance NeuroNews International
Radiosurgery Planning System Receives FDA 510(k), CE Clearance - Imaging Technology News

Radiosurgery Planning System Receives FDA 510(k), CE Clearance Imaging Technology News
Precigen Inc (PGEN) Q3 2025 Earnings Call Highlights: FDA Approval and U.S. ... - Yahoo Finance

Precigen Inc (PGEN) Q3 2025 Earnings Call Highlights: FDA Approval and U.S. ... Yahoo Finance
FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths - Toronto Star

FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths Toronto Star
Insight Molecular Diagnostics: GraftAssureDX FDA Submission Warrants Hold Rating (IMDX) - Seeking...

Insight Molecular Diagnostics: GraftAssureDX FDA Submission Warrants Hold Rating (IMDX) Seeking Alpha
FDA issues health alert for raw pet food contaminated with avian influenza - Earth.com

FDA issues health alert for raw pet food contaminated with avian influenza Earth.com
Tandem Diabetes Care (TNDM) Is Up 31.5% After FDA Clears Android App for Insulin Management – Wha...

Tandem Diabetes Care (TNDM) Is Up 31.5% After FDA Clears Android App for Insulin Management – What's Changed simplywall.st
Pharma Pulse: FDA Advances New Approval Pathway, as Obesity Care and Metabolic Treatments Gain Mo...

Pharma Pulse: FDA Advances New Approval Pathway, as Obesity Care and Metabolic Treatments Gain Momentum Pharmaceutical Commerce
Sarepta gene therapy Elevidys gets FDA Boxed Warning following two patient deaths - Seeking Alpha

Sarepta gene therapy Elevidys gets FDA Boxed Warning following two patient deaths Seeking Alpha
Food Allergies - fda.gov

Food Allergies fda.gov
Supplement powder mix recalled nationwide; FDA investigates - ABC27

Supplement powder mix recalled nationwide; FDA investigates ABC27
Ingenus Pharmaceuticals Announces FDA Approval and Launch of First and Only Generic Equivalent to...

The EU should follow the FDA’s harm-reduction strategy - Washington Examiner

The EU should follow the FDA’s harm-reduction strategy Washington Examiner
SMX (NASDAQ: SMX) embeds 21 CFR Food Contact markers in rPET for certified traceability - Stock T...

SMX (NASDAQ: SMX) embeds 21 CFR Food Contact markers in rPET for certified traceability Stock Titan
FDA Moves to Streamline Biosimilar Development: Implications for Regulatory Strategy and Clinical...

FDA Moves to Streamline Biosimilar Development: Implications for Regulatory Strategy and Clinical Study Design Wilson Sonsini
FDA Leadership Outlines “Plausible Mechanism” Pathway for Bespoke Therapies - Foley Hoag

FDA Leadership Outlines “Plausible Mechanism” Pathway for Bespoke Therapies Foley Hoag
Philips receives FDA 510(k) clearance for Cardiovascular Workspace - Philips

Philips receives FDA 510(k) clearance for Cardiovascular Workspace Philips
Invivyd, Inc. Stock (IVVD) Opinions on Q3 2025 Financial Results and FDA Clearance - Quiver Quant...

Invivyd, Inc. Stock (IVVD) Opinions on Q3 2025 Financial Results and FDA Clearance Quiver Quantitative
'It just doesn't work': FDA proposes to end use of some OTC cold medications - Spectrum News 1

'It just doesn't work': FDA proposes to end use of some OTC cold medications Spectrum News 1
St. Louis startup’s novel spine screw gets FDA clearance for patient use - St. Louis Magazine

St. Louis startup’s novel spine screw gets FDA clearance for patient use St. Louis Magazine
Sunscreen: How to Help Protect Your Skin from the Sun - fda.gov

Sunscreen: How to Help Protect Your Skin from the Sun fda.gov
FDA Ends Estrogen Black Box Warning—a Move That Could Transform Menopause Care Forever - Woman's ...

FDA Ends Estrogen Black Box Warning—a Move That Could Transform Menopause Care Forever Woman's World
FDA is recalling over 6 million eggs due to salmonella contamination - Earth.com

FDA is recalling over 6 million eggs due to salmonella contamination Earth.com
Kura Oncology and Kyowa Kirin Announce FDA Approval of KOMZIFTI™ (ziftomenib), the First and Only...

BrainStorm (OTCQB: BCLI) gets FDA clearance for Phase 3b ALS trial; net loss $2.1M - Stock Titan

BrainStorm (OTCQB: BCLI) gets FDA clearance for Phase 3b ALS trial; net loss $2.1M Stock Titan
FDA removes menopause hormone therapy black box warnings - Harvard Health

FDA removes menopause hormone therapy black box warnings Harvard Health
HeartBeam (NASDAQ: BEAT) Reports Q3 2025 Results as FDA Review Nears Completion and Commercial Re...

FDA Downsizing Imperils Clinical Trial Oversight: Ethicist - Medscape

FDA Downsizing Imperils Clinical Trial Oversight: Ethicist Medscape
FDA Accepts Outlook Therapeutics' Resubmitted BLA For ONS-5010 In Wet AMD, Decision Due In Decemb...

FDA Accepts Outlook Therapeutics' Resubmitted BLA For ONS-5010 In Wet AMD, Decision Due In December Nasdaq