"FDA" の関連情報検索結果

Blood pressure tech floods the market after FDA relaxes wearables oversight - statnews.com



Blood pressure tech floods the market after FDA relaxes wearables oversight  statnews.com

US FDA decision date extended for SERENA-6 filing of camizestrant to enable review of additional ...



US FDA decision date extended for SERENA-6 filing of camizestrant to enable review of additional data  AstraZeneca

FDA panel recommends updating Covid shots to target XFG strain - NBC News



  1. FDA panel recommends updating Covid shots to target XFG strain  NBC News
  2. FDA advisers recommend COVID vaccines be updated to target current dominant variant  Reuters
  3. FDA vaccine advisers recommend updating COVID shots  Axios

Viridian, awaiting FDA decision, taps WuXi Bio in supply deal - Fierce Pharma



Viridian, awaiting FDA decision, taps WuXi Bio in supply deal  Fierce Pharma

Seasoning sold at SC Walmart stores recalled due to salmonella risk, FDA says - Post and Courier



Seasoning sold at SC Walmart stores recalled due to salmonella risk, FDA says  Post and Courier

FDA extends Beren’s rare disease review after info request, further stretching saga - Fierce Biotech



FDA extends Beren’s rare disease review after info request, further stretching saga  Fierce Biotech

Warnings issued to Alabama doctors against non-FDA-approved peptides amid social media popularity...



Warnings issued to Alabama doctors against non-FDA-approved peptides amid social media popularity  WSFA

ADC from AbbVie's ImmunoGen takeout wins FDA approval for rare blood cancer - FirstWord Pharma



ADC from AbbVie's ImmunoGen takeout wins FDA approval for rare blood cancer  FirstWord Pharma

With Elahere building steam, AbbVie nets FDA nod for another ImmunoGen cancer asset - Fierce Pharma



With Elahere building steam, AbbVie nets FDA nod for another ImmunoGen cancer asset  Fierce Pharma

AbbVie snags FDA’s first ADC approval for ultra-rare blood cancer - BioSpace



AbbVie snags FDA’s first ADC approval for ultra-rare blood cancer  BioSpace

FDA Approves OTC Switch for Topical Acne Treatment - Medscape



FDA Approves OTC Switch for Topical Acne Treatment  Medscape

MNKD Stock Eyes Best Month Since 2022 Ahead Of FDA Decision On Pediatric Diabetes Treatment - Yah...



MNKD Stock Eyes Best Month Since 2022 Ahead Of FDA Decision On Pediatric Diabetes Treatment  Yahoo Finance

FDA Grants Fast Track Designation to STX-0712 for R/R CMML - Targeted Oncology



FDA Grants Fast Track Designation to STX-0712 for R/R CMML  Targeted Oncology

Industry Confidence In FDA May Hinge On CBER, CDER Leadership, Inside Health Policy - Morgan Lewis



Industry Confidence In FDA May Hinge On CBER, CDER Leadership, Inside Health Policy  Morgan Lewis

FDA Approves Durvalumab Plus BCG for High-Risk NMIBC - OncLive



FDA Approves Durvalumab Plus BCG for High-Risk NMIBC  OncLive

Durvalumab Plus BCG Earns FDA Approval For High-Risk NMIBC - CancerNetwork



Durvalumab Plus BCG Earns FDA Approval For High-Risk NMIBC  CancerNetwork

FDA Approves Durvalumab and BCG for High-Risk NMIBC - Oncology Nursing News



FDA Approves Durvalumab and BCG for High-Risk NMIBC  Oncology Nursing News

FDA provides additional examples, clarity in human factors guidance - RAPS.org



FDA provides additional examples, clarity in human factors guidance  RAPS.org

FDA Approves Imfinzi Plus BCG for High-Risk Bladder Cancer - Cure Today



FDA Approves Imfinzi Plus BCG for High-Risk Bladder Cancer  Cure Today

US FDA approves AbbVie's rare blood cancer drug - Reuters



US FDA approves AbbVie's rare blood cancer drug  Reuters

FDA Releases Discussion Paper Ahead of Traceability Public Meeting in June - Quality Assurance & ...



FDA Releases Discussion Paper Ahead of Traceability Public Meeting in June  Quality Assurance & Food Safety

FDA Grants Priority Review to Finerenone sNDA for Type 1 Diabetes-Associated CKD - Docwire News



FDA Grants Priority Review to Finerenone sNDA for Type 1 Diabetes-Associated CKD  Docwire News

FDA Approves Durvalumab Plus BCG for High-Risk NMIBC - Targeted Oncology



FDA Approves Durvalumab Plus BCG for High-Risk NMIBC  Targeted Oncology

FDA Approves Pivekimab Sunirine for Blastic Plasmacytoid Dendritic Cell Neoplasm - OncLive



FDA Approves Pivekimab Sunirine for Blastic Plasmacytoid Dendritic Cell Neoplasm  OncLive

Neladalkib Earns FDA Priority Review in ALK-Positive NSCLC - CancerNetwork



Neladalkib Earns FDA Priority Review in ALK-Positive NSCLC  CancerNetwork

FDA Updates Pesticide Monitoring Compliance Program - Quality Assurance & Food Safety



FDA Updates Pesticide Monitoring Compliance Program  Quality Assurance & Food Safety

FDA Grants Priority Review for Bezuclastinib Plus Sunitinib in GIST - Targeted Oncology



FDA Grants Priority Review for Bezuclastinib Plus Sunitinib in GIST  Targeted Oncology

FDA Approves Pivekimab Sunirine for BPDCN - Targeted Oncology



FDA Approves Pivekimab Sunirine for BPDCN  Targeted Oncology

FDA’s Advisory Panel Votes in Favor of Updating Covid-19 Vaccine Shots to Target XFG Variant - Ph...



FDA’s Advisory Panel Votes in Favor of Updating Covid-19 Vaccine Shots to Target XFG Variant  Pharmaceutical Executive

FDA Grants Priority Review to Saroglitazar NDA for Primary Biliary Cholangitis - HCPLive



FDA Grants Priority Review to Saroglitazar NDA for Primary Biliary Cholangitis  HCPLive

FDA Approves Pivekimab Sunirine for BPDCN - Oncology News Central



FDA Approves Pivekimab Sunirine for BPDCN  Oncology News Central

US FDA advisers vote in favor of recommending COVID vaccines target XFG variant - Reuters



US FDA advisers vote in favor of recommending COVID vaccines target XFG variant  Reuters

Recon: FDA delays on AstraZeneca’s experimental breast cancer therapy; Abbott earns CE mark for d...



Recon: FDA delays on AstraZeneca’s experimental breast cancer therapy; Abbott earns CE mark for dual glucose-ketone sensor  RAPS.org

Balance Ophthalmics receives FDA 510(k) clearance for wireless-enabled nocturnal IOP device - Oph...



Balance Ophthalmics receives FDA 510(k) clearance for wireless-enabled nocturnal IOP device  Ophthalmology Times

FDA decision on BBP-418 for LGMD2i expected in late November - Muscular Dystrophy News



FDA decision on BBP-418 for LGMD2i expected in late November  Muscular Dystrophy News

FDA Approves Durvalumab Plus BCG for High-Risk Non–Muscle-Invasive Bladder Cancer - Pharmacy Times



FDA Approves Durvalumab Plus BCG for High-Risk Non–Muscle-Invasive Bladder Cancer  Pharmacy Times

Pharmacy NDC Transition FDA 12 Digit Rule Overview - Specialty Pharmacy Continuum



Pharmacy NDC Transition FDA 12 Digit Rule Overview  Specialty Pharmacy Continuum

FDA extends adrabetadex NDA review for infantile-onset Niemann-Pick disease type C - Contemporary...



FDA extends adrabetadex NDA review for infantile-onset Niemann-Pick disease type C  Contemporary Pediatrics

FDA Modernizes Oversight of Pesticides in Food - Food Safety Magazine



FDA Modernizes Oversight of Pesticides in Food  Food Safety Magazine

A Drama-Free FDA Is a Win for the White House - Bloomberg.com



A Drama-Free FDA Is a Win for the White House  Bloomberg.com

FDA accelerated approval of Hepcludex significant milestone for US HDV market - Clinical Trials A...



FDA accelerated approval of Hepcludex significant milestone for US HDV market  Clinical Trials Arena

Clariant secures FDA approval for bio-based Licocare™ RBW additives in rigid PVC food-contact app...



Clariant secures FDA approval for bio-based Licocare™ RBW additives in rigid PVC food-contact applications  Clariant

BrainStorm Cell Therapeutics Appoints Former FDA Associate Commissioner Peter J. Pitts to Board o...



BrainStorm Cell Therapeutics Appoints Former FDA Associate Commissioner Peter J. Pitts to Board of Directors  PR Newswire

FDA Expands Approval of Linzess for Patients as Young as 2 Years - Drug Topics



FDA Expands Approval of Linzess for Patients as Young as 2 Years  Drug Topics

FDA Investigates New Salmonella Outbreak Linked to MOGO Moringa Capsules - Quality Assurance & Fo...



FDA Investigates New Salmonella Outbreak Linked to MOGO Moringa Capsules  Quality Assurance & Food Safety

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 delays ruling on AstraZeneca drug after negative adcomm vote - Fierce Biotech



FDA delays ruling on AstraZeneca drug after negative adcomm vote  Fierce Biotech

Beren Therapeutics Announces FDA Extension of Review Period for New Drug Application (NDA) for Ad...



Beren Therapeutics Announces FDA Extension of Review Period for New Drug Application (NDA) for Adrabetadex for the Treatment of Infantile-Onset Niemann-Pick Disease, Type C  BioSpace

FDA OKs Immunotherapy-BCG Combo for High-Risk Bladder Cancer - MedPage Today



FDA OKs Immunotherapy-BCG Combo for High-Risk Bladder Cancer  MedPage Today

AbbVie’s ADC Strategy Notches Another Win With FDA Approval in Ultra-Rare Blood Cancer - MedCity ...



AbbVie’s ADC Strategy Notches Another Win With FDA Approval in Ultra-Rare Blood Cancer  MedCity News

FDA Approves Novel Targeted Therapy for Rare Blood Cancer - Medscape



FDA Approves Novel Targeted Therapy for Rare Blood Cancer  Medscape

Alife Health Receives FDA Clearance for AI-Powered Embryo Assessment - PR Newswire



Alife Health Receives FDA Clearance for AI-Powered Embryo Assessment  PR Newswire

CIDRAP Op-Ed: Manufacturing a scandal: What the FDA’s COVID vaccine pediatric death review actual...



CIDRAP Op-Ed: Manufacturing a scandal: What the FDA’s COVID vaccine pediatric death review actually says  CIDRAP

FDA grants breakthrough designation to Coredio heart failure assessment platform - Medical Economics



FDA grants breakthrough designation to Coredio heart failure assessment platform  Medical Economics

Clariant Wins FDA Approval for Bio-Based PVC Additives - PlasticsToday



Clariant Wins FDA Approval for Bio-Based PVC Additives  PlasticsToday

Vyome Holdings Reports First Quarter 2026 Results With Key FDA Filings and Strong Balance Sheet -...



Vyome Holdings Reports First Quarter 2026 Results With Key FDA Filings and Strong Balance Sheet  BioSpace

FDA Approves DECNUPAZ for Blastic Plasmacytoid Dendritic Cell Neoplasm - The Clinical Trial Vanguard



FDA Approves DECNUPAZ for Blastic Plasmacytoid Dendritic Cell Neoplasm  The Clinical Trial Vanguard

Procept Biorobotics wins expanded FDA IDE for Aquablation, completes study enrollment - MassDevice



Procept Biorobotics wins expanded FDA IDE for Aquablation, completes study enrollment  MassDevice

Tracking Food Industry Pledges to Remove Petroleum Based Food Dyes - fda.gov



Tracking Food Industry Pledges to Remove Petroleum Based Food Dyes  fda.gov

IRWD's Linzess Wins FDA Nod for Expanded Pediatric Constipation Use - Yahoo Finance



IRWD's Linzess Wins FDA Nod for Expanded Pediatric Constipation Use  Yahoo Finance

As FDA’s wheels almost entirely come off, NCI remains sturdy—a cancer moonshot may even be on the...



As FDA’s wheels almost entirely come off, NCI remains sturdy—a cancer moonshot may even be on the horizon  The Cancer Letter

FDA Approves Pivekimab Sunirine in Rare Hematologic Malignancy - CancerNetwork



FDA Approves Pivekimab Sunirine in Rare Hematologic Malignancy  CancerNetwork

ReST Therapeutics Announces U.S. FDA Acceptance of Investigational New Drug (IND) Application for...



ReST Therapeutics Announces U.S. FDA Acceptance of Investigational New Drug (IND) Application for RST-101 for the Early Treatment of Post-Traumatic Stress Disorder (PTSD)  Yahoo Finance

Big Tobacco comes out on top after US FDA shake-up - Reuters



Big Tobacco comes out on top after US FDA shake-up  Reuters

FDA Announces Recall on Popular Candy Due To Life-Threatening Allergen - Allrecipes



FDA Announces Recall on Popular Candy Due To Life-Threatening Allergen  Allrecipes

The Evolving Biopharma Regulatory Landscape: Q&A with Harpreet Singh, MD - Pharmaceutical Executive



The Evolving Biopharma Regulatory Landscape: Q&A with Harpreet Singh, MD  Pharmaceutical Executive

PINK: Q1 2026 saw recurring revenue growth, FDA approval for Claire OCT + AI, and improved net lo...



PINK: Q1 2026 saw recurring revenue growth, FDA approval for Claire OCT + AI, and improved net loss  TradingView

Improving FDA & Biopharma's Relationship - Pharmaceutical Executive



Improving FDA & Biopharma's Relationship  Pharmaceutical Executive

FDA Extends Action Date for Camizestrant in Advanced Breast Cancer - Targeted Oncology



FDA Extends Action Date for Camizestrant in Advanced Breast Cancer  Targeted Oncology

Infant Formula Homepage - fda.gov



Infant Formula Homepage  fda.gov

FDA Grants Priority Review to Neladalkib NDA for ALK-Positive NSCLC - Targeted Oncology



FDA Grants Priority Review to Neladalkib NDA for ALK-Positive NSCLC  Targeted Oncology

Alzprotect Announces FDA Clearance of IND for AZP2006 (Ezeprogind®) in Progressive Supranuclear P...



Alzprotect Announces FDA Clearance of IND for AZP2006 (Ezeprogind®) in Progressive Supranuclear Palsy (PSP)  BioSpace

Zydus Therapeutics New Drug Application (NDA) for Saroglitazar to Treat Primary Biliary Cholangit...



Zydus Therapeutics New Drug Application (NDA) for Saroglitazar to Treat Primary Biliary Cholangitis (PBC) Granted Priority Review by the US FDA  PR Newswire

FDA Recall on Gas X: What to Know About Recalled Batches and Safety - EatingWell



FDA Recall on Gas X: What to Know About Recalled Batches and Safety  EatingWell

Accelerating Rare disease Cures (ARC) Program - fda.gov



Accelerating Rare disease Cures (ARC) Program  fda.gov

AstraZeneca gains 2nd bladder cancer nod in key expansion for Imfinzi - Fierce Pharma



AstraZeneca gains 2nd bladder cancer nod in key expansion for Imfinzi  Fierce Pharma

FDA Extends Decision Date for Camizestrant in HR+ Advanced Breast Cancer With an Emergent ESR1 Mu...



FDA Extends Decision Date for Camizestrant in HR+ Advanced Breast Cancer With an Emergent ESR1 Mutation  OncLive

Fifty Years of the Medical Device Amendments - fda.gov



Fifty Years of the Medical Device Amendments  fda.gov

FDA Approved Pivekimab Sunirine‑Pvzy for Adult Patients – BPDCN International Registry - Oncodaily



FDA Approved Pivekimab Sunirine‑Pvzy for Adult Patients – BPDCN International Registry  Oncodaily

Momentum Amidst Tumult: The FDA Reshuffle, Approval Timelines, and the Compass-Usona Race - Psych...



Momentum Amidst Tumult: The FDA Reshuffle, Approval Timelines, and the Compass-Usona Race  Psychedelic Alpha

AbbVie Wins FDA Nod for Decnupaz for Rare Blood Cancer Indication - Yahoo Finance



AbbVie Wins FDA Nod for Decnupaz for Rare Blood Cancer Indication  Yahoo Finance

FDA advisers to weigh composition of COVID vaccines for 2026-2027 - whbl.com



FDA advisers to weigh composition of COVID vaccines for 2026-2027  whbl.com

FDA delays decision on AstraZeneca breast cancer pill - BioPharma Dive



FDA delays decision on AstraZeneca breast cancer pill  BioPharma Dive

Alabama warns healthcare providers against use of non-FDA-approved peptides - Reuters



Alabama warns healthcare providers against use of non-FDA-approved peptides  Reuters

FDA Approves Pivekimab Sunirine-pvzy for BPDCN - Oncology Nursing News



FDA Approves Pivekimab Sunirine-pvzy for BPDCN  Oncology Nursing News

FDA Grants Coredio Breakthrough Designation for AI Platform Bringing Advanced Heart Failure Asses...



FDA Grants Coredio Breakthrough Designation for AI Platform Bringing Advanced Heart Failure Assessment Beyond the Hospital  Business Wire

Sanofi’s venglustat accepted for priority review by FDA - The Pharma Letter



Sanofi’s venglustat accepted for priority review by FDA  The Pharma Letter

FDA Expands Market Access, Authorizes New ENDS Products - fda.gov



FDA Expands Market Access, Authorizes New ENDS Products  fda.gov

FDA refuses to be ghosted on clinical trial data - JD Supra



FDA refuses to be ghosted on clinical trial data  JD Supra

RenovoRx Announces FDA Orphan Drug Designation Granted: Oxaliplatin for the Treatment of Pancreat...



RenovoRx Announces FDA Orphan Drug Designation Granted: Oxaliplatin for the Treatment of Pancreatic Cancer  Investing News Network

OTLK Stock Rocket Nearly 140%: FDA's Lytenava Approval Pushes Stock On Track For Best Week On Rec...



OTLK Stock Rocket Nearly 140%: FDA's Lytenava Approval Pushes Stock On Track For Best Week On Record  Stocktwits

Ex-FDA official joins ALS trial push after first-ever SPA for ALS - Stock Titan



Ex-FDA official joins ALS trial push after first-ever SPA for ALS  Stock Titan

FDA oncology roundup: AbbVie’s rare cancer approval, AstraZeneca in breast cancer limbo - Yahoo



FDA oncology roundup: AbbVie’s rare cancer approval, AstraZeneca in breast cancer limbo  Yahoo

Raffaele Colombo: FDA Approves Pivekimab Sunirine Based on CADENZA Trial - Oncodaily



Raffaele Colombo: FDA Approves Pivekimab Sunirine Based on CADENZA Trial  Oncodaily

FDA OKs Decnupaz for Adults With Blastic Plasmacytoid Dendritic Cell Neoplasm - Cure Today



FDA OKs Decnupaz for Adults With Blastic Plasmacytoid Dendritic Cell Neoplasm  Cure Today

FDA Approves Durvalumab In Combination With Bacillus Calmette-Guerin - TradingView



FDA Approves Durvalumab In Combination With Bacillus Calmette-Guerin  TradingView

APYX: FDA-cleared technologies and cost discipline drive growth in the expanding surgical aesthet...



APYX: FDA-cleared technologies and cost discipline drive growth in the expanding surgical aesthetics market  TradingView

Clariant obtains FDA approval for renewable rice bran wax additives in PVC food packs - Packaging...



Clariant obtains FDA approval for renewable rice bran wax additives in PVC food packs  Packaging Insights

FDA Announces Recall on Supplement Due to Multistate Salmonella Outbreak—Here’s What to Know - Ea...



FDA Announces Recall on Supplement Due to Multistate Salmonella Outbreak—Here’s What to Know  EatingWell

FDA clears AbbVie’s Decnupaz for rare blood cancer - The Pharma Letter



FDA clears AbbVie’s Decnupaz for rare blood cancer  The Pharma Letter

Cogent Biosciences Announces FDA Acceptance of New Drug Application with Priority Review for Bezu...



Cogent Biosciences Announces FDA Acceptance of New Drug Application with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GIST  Investing News Network

No child deaths definitively linked to Covid shots, FDA says - NBC News



No child deaths definitively linked to Covid shots, FDA says  NBC News