"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



  1. FDA chiefs offer roadmap to expand custom gene-editing treatments like Baby KJ’s  statnews.com
  2. FDA opens up new approval pathway for personalised rare disease treatments  FirstWord Pharma
  3. FDA unveils new path to speed personalized therapies, inspired by Baby KJ  Endpoints News

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



The FDA's self-fulfilling prophecy trap  Axios

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



  1. F.D.A. Names Agency Veteran to Run Drug Division  The New York Times
  2. FDA names longtime oncology chief Richard Pazdur as new CDER director  Fierce Pharma
  3. The FDA Has a New Drug Chief. What it Means for Biotech Stocks.  Barron's

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



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



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...



FDA Issues Warning to Over a Dozen Companies Selling Counterfeit Botox — Including Several in the U.S.  People.com

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...



Moonlight Companies Voluntarily Recalls California-Grown Conventional Yellow and White Peaches Because of Possible Health Risk- Revised to Clarify Upc Codes; This Recall Has Not Been Expanded  fda.gov

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...



Captiva Spine Announces FDA Clearance for Flat-Panel C-Arm Image Calibrators and AI-Assisted Registration for WatchTower Spine Navigation, Advancing Efficiency, Radiation Reduction, and Future-Ready Access – Ortho Spine News  Ortho Spine News

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...



Ingenus Pharmaceuticals Announces FDA Approval and Launch of First and Only Generic Equivalent to Premarin® Tablets (Conjugated Estrogens Tablets, USP)  BioSpace

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...



Kura Oncology and Kyowa Kirin Announce FDA Approval of KOMZIFTI™ (ziftomenib), the First and Only Once-Daily Targeted Therapy for Adults with Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia  Yahoo Finance

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...



HeartBeam (NASDAQ: BEAT) Reports Q3 2025 Results as FDA Review Nears Completion and Commercial Readiness Accelerates  TradingView

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