"FDA" の関連情報検索結果

Disagreements over Duchenne therapy, management style may have led to ouster of key FDA official ...



Disagreements over Duchenne therapy, management style may have led to ouster of key FDA official  STAT

FDA blocks new clinical trials that ship cells from US to China - Fierce Biotech



FDA blocks new clinical trials that ship cells from US to China  Fierce Biotech

Seven Things to Know About ProPublica’s Investigation of the FDA’s Secret Gamble on Generic Drugs...



Seven Things to Know About ProPublica’s Investigation of the FDA’s Secret Gamble on Generic Drugs  ProPublica

FDA chief’s goals of ‘radical transparency’ threatened by agency cuts - STAT



FDA chief’s goals of ‘radical transparency’ threatened by agency cuts  STAT

His Kidney Failed. He’ll Never Know if a Transplant Drug From a Banned Factory Was to Blame. - Pr...



His Kidney Failed. He’ll Never Know if a Transplant Drug From a Banned Factory Was to Blame.  ProPublica

Supreme Court rules against FDA, EPA - The Hill



Supreme Court rules against FDA, EPA  The Hill

The FDA Just Approved a Long-Lasting Injection to Prevent HIV - WIRED



The FDA Just Approved a Long-Lasting Injection to Prevent HIV  WIRED

Human thumb found in sweet; FDA visits shop in Pune - Hindustan Times



Human thumb found in sweet; FDA visits shop in Pune  Hindustan Times

Threat in your medicine cabinet: The FDA’s gamble on America’s drugs - CNN



Threat in your medicine cabinet: The FDA’s gamble on America’s drugs  CNN

Healthy Returns: What to know about the FDA’s plan to speed up some drug reviews - CNBC



Healthy Returns: What to know about the FDA’s plan to speed up some drug reviews  CNBC

Outbreak Investigation of Listeria monocytogenes: Chicken Fettuccine Alfredo Meals (June 2025) - ...



Outbreak Investigation of Listeria monocytogenes: Chicken Fettuccine Alfredo Meals (June 2025)  fda.gov

Food and Drug Administration - Britannica



Food and Drug Administration  Britannica

Larimar Therapeutics Announces FDA Recommendations on - GlobeNewswire



Larimar Therapeutics Announces FDA Recommendations on  GlobeNewswire

FDA approval of injectable lenacapavir marks progress for HIV prevention - World Health Organizat...



FDA approval of injectable lenacapavir marks progress for HIV prevention  World Health Organization (WHO)

FDA Grants First-Ever Clearance of Clinical Laboratory Blood Test for Alzheimer’s Detection - Dar...



FDA Grants First-Ever Clearance of Clinical Laboratory Blood Test for Alzheimer’s Detection  Dark Daily

Gene therapy faces fresh uncertainty as two more top FDA officials depart - BioPharma Dive



Gene therapy faces fresh uncertainty as two more top FDA officials depart  BioPharma Dive

HIV prevention drug hailed as a 'breakthrough' gets FDA approval : Goats and Soda - NPR



HIV prevention drug hailed as a 'breakthrough' gets FDA approval : Goats and Soda  NPR

US FDA to shorten review time for drug developers under new voucher program - Reuters



US FDA to shorten review time for drug developers under new voucher program  Reuters

H.C. Wainwright reaffirms Capricor Therapeutics stock rating amid FDA changes - Investing.com



H.C. Wainwright reaffirms Capricor Therapeutics stock rating amid FDA changes  Investing.com

Next-gen Medtronic insulin pump reportedly set for FDA submission, patch pump on the way - Drug D...



Next-gen Medtronic insulin pump reportedly set for FDA submission, patch pump on the way  Drug Delivery Business

FDA Approves a Twice-Yearly Shot to Prevent HIV - Time Magazine



FDA Approves a Twice-Yearly Shot to Prevent HIV  Time Magazine

Food Chemical Safety - fda.gov



Food Chemical Safety  fda.gov

US judge upholds FDA's removal of Ozempic, Wegovy from drug shortage list - Reuters



US judge upholds FDA's removal of Ozempic, Wegovy from drug shortage list  Reuters

FDA’s Nutrition Initiatives - fda.gov



FDA’s Nutrition Initiatives  fda.gov

Top gene therapy regulator forced out at FDA - STAT



Top gene therapy regulator forced out at FDA  STAT

FDA approves powerful HIV prevention drug: What to know about Yeztugo - NBC News



FDA approves powerful HIV prevention drug: What to know about Yeztugo  NBC News

FDA to speed reviews for drugs supporting ‘national interests’ - BioPharma Dive



FDA to speed reviews for drugs supporting ‘national interests’  BioPharma Dive

Capricor stock price target cut by Oppenheimer on FDA review concerns - Investing.com



Capricor stock price target cut by Oppenheimer on FDA review concerns  Investing.com

Vinay Prasad named chief medical and science officer at FDA - STAT



Vinay Prasad named chief medical and science officer at FDA  STAT

Biotech Stocks Facing FDA Decision In July 2025 - RTTNews



Biotech Stocks Facing FDA Decision In July 2025  RTTNews

Archeus Technologies Receives FDA Clearance of Investigational New Drug Application for ART-101 i...



Archeus Technologies Receives FDA Clearance of Investigational New Drug Application for ART-101 in Development for the Treatment of Prostate Cancer  BioSpace

Threat in Your Medicine Cabinet: The FDA’s Gamble on America’s Drugs - ProPublica



Threat in Your Medicine Cabinet: The FDA’s Gamble on America’s Drugs  ProPublica

Opinion | How we plan to cut FDA drug approval time by months - The Washington Post



Opinion | How we plan to cut FDA drug approval time by months  The Washington Post

US FDA approves Gilead's twice-yearly injection for HIV prevention - Reuters



US FDA approves Gilead's twice-yearly injection for HIV prevention  Reuters

Update on FDA Review of Ruxolitinib Cream (Opzelura®) for Children Ages 2-11 with Atopic Dermatit...



Update on FDA Review of Ruxolitinib Cream (Opzelura®) for Children Ages 2-11 with Atopic Dermatitis  BioSpace

HIV protection with just two shots a year: FDA approves Gilead drug - STAT



HIV protection with just two shots a year: FDA approves Gilead drug  STAT

FDA announces a new priority review program in bid to further administration goals | STAT - STAT



FDA announces a new priority review program in bid to further administration goals | STAT  STAT

FDA approves twice-a-year injection for HIV prevention - CNN



FDA approves twice-a-year injection for HIV prevention  CNN

Industry deeply disappointed as FDA reportedly puts cell and gene therapy chief on leave - Fierce...



Industry deeply disappointed as FDA reportedly puts cell and gene therapy chief on leave  Fierce Biotech

Does the FDA commissioner’s new voucher program open a Pandora’s box? - STAT



Does the FDA commissioner’s new voucher program open a Pandora’s box?  STAT

Martin A Makary M.D., M.P.H. - fda.gov



Martin A Makary M.D., M.P.H.  fda.gov

FDA Approves Gilead’s Twice-Yearly Injectable Lenacapavir (Yeztugo) for HIV Prevention - Contagio...



FDA Approves Gilead’s Twice-Yearly Injectable Lenacapavir (Yeztugo) for HIV Prevention  ContagionLive

FDA approves powerful new HIV drug - NBC News



FDA approves powerful new HIV drug  NBC News

Nicole Verdun Exits FDA as CBER Director Vinay Prasad ‘Consolidates Power’ - BioSpace



Nicole Verdun Exits FDA as CBER Director Vinay Prasad ‘Consolidates Power’  BioSpace

FDA approves new twice-yearly HIV shot. What to know - USA Today



FDA approves new twice-yearly HIV shot. What to know  USA Today

FDA issues warning letters to four companies for foreign supplier verification failures - Food Sa...



FDA issues warning letters to four companies for foreign supplier verification failures  Food Safety News

FDA approves first semiannual HIV prevention drug - American Hospital Association



FDA approves first semiannual HIV prevention drug  American Hospital Association

Sanofi/Regeneron’s Dupixent granted FDA approval for bullous pemphigoid - PMLiVE



Sanofi/Regeneron’s Dupixent granted FDA approval for bullous pemphigoid  PMLiVE

FDA Shakeup Continues As Two Key Officials Ousted - Investor's Business Daily



FDA Shakeup Continues As Two Key Officials Ousted  Investor's Business Daily

FDA Rare Disease Innovation Hub - fda.gov



FDA Rare Disease Innovation Hub  fda.gov

FDA Limits Pembrolizumab/Nivolumab in PD-L1–Low Gastric Cancer Indications - CancerNetwork



FDA Limits Pembrolizumab/Nivolumab in PD-L1–Low Gastric Cancer Indications  CancerNetwork

FDA to offer faster drug reviews to companies promoting ‘national priorities’ - AP News



FDA to offer faster drug reviews to companies promoting ‘national priorities’  AP News

FDA Expands Approval for RSV Vaccine for Adults Under 60 - The Presidential Prayer Team



FDA Expands Approval for RSV Vaccine for Adults Under 60  The Presidential Prayer Team

New FDA Chief Wants to Fast-Track Some Drugs, Use More AI - WSJ



New FDA Chief Wants to Fast-Track Some Drugs, Use More AI  WSJ

Yeztugo® (Lenacapavir) Is Now the First and Only FDA-Approved HIV Prevention Option Offering 6 Mo...



Yeztugo® (Lenacapavir) Is Now the First and Only FDA-Approved HIV Prevention Option Offering 6 Months of Protection  Business Wire

Amarin, Merck alum Karim Mikhail emerges as possible head of FDA’s CDER - biocentury.com



Amarin, Merck alum Karim Mikhail emerges as possible head of FDA’s CDER  biocentury.com

Makary names Prasad as FDA’s chief medical and scientific officer - Regulatory Affairs Profession...



Makary names Prasad as FDA’s chief medical and scientific officer  Regulatory Affairs Professionals Society | RAPS

FDA’s removal of Ozempic, Wegovy from drug shortage list upheld - The Hill



FDA’s removal of Ozempic, Wegovy from drug shortage list upheld  The Hill

HIV prevention drug lenacapavir approved by FDA as twice-yearly injection - CBS News



HIV prevention drug lenacapavir approved by FDA as twice-yearly injection  CBS News

FDA Approval: Illuccix Expansion Could Add 20,000 Annual Prostate Cancer Scans - Stock Titan



FDA Approval: Illuccix Expansion Could Add 20,000 Annual Prostate Cancer Scans  Stock Titan

How does the FDA determine food is safe? - KOIN.com



How does the FDA determine food is safe?  KOIN.com

FDA under fire: Data discrepancies uncovered in AstraZeneca approval trials - ScienceDaily



FDA under fire: Data discrepancies uncovered in AstraZeneca approval trials  ScienceDaily

FDA-Approved Sleeping Pill Slows Alzheimer's Tangles in Pre-Clinical Trial - ScienceAlert



FDA-Approved Sleeping Pill Slows Alzheimer's Tangles in Pre-Clinical Trial  ScienceAlert

FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People - fda.gov



FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People  fda.gov

FDA approves Gilead's twice-yearly HIV prevention injection, offering a powerful and convenient n...



FDA approves Gilead's twice-yearly HIV prevention injection, offering a powerful and convenient new option  CNBC

Psychedelics proponents hope Trump administration will foster a new era - STAT



Psychedelics proponents hope Trump administration will foster a new era  STAT

FDA announces new voucher program for drugs tied to national priorities - Regulatory Affairs Prof...



FDA announces new voucher program for drugs tied to national priorities  Regulatory Affairs Professionals Society | RAPS

The world's only twice-a-year shot to prevent HIV could stop transmission — if people can get it ...



The world's only twice-a-year shot to prevent HIV could stop transmission — if people can get it  AP News

FDA Roundtable Addresses Regulatory Approach to Gene Therapies for Rare Diseases - geneonline.com



FDA Roundtable Addresses Regulatory Approach to Gene Therapies for Rare Diseases  geneonline.com

Statement from amfAR on FDA Approval of Lenacapavir for HIV Pre-Exposure Prophylaxis - amfAR, The...



Statement from amfAR on FDA Approval of Lenacapavir for HIV Pre-Exposure Prophylaxis  amfAR, The Foundation for AIDS Research

FDA Advises Consumers, Retailers, and Distributors Not to Eat, Sell, o - fda.gov



FDA Advises Consumers, Retailers, and Distributors Not to Eat, Sell, o  fda.gov

Marty Makary talks DOGE cuts, new voucher program and why FDA still 'on track' to meet all PDUFA ...



Marty Makary talks DOGE cuts, new voucher program and why FDA still 'on track' to meet all PDUFA dates  Fierce Biotech

Hall County family urges FDA approval for experimental drug to save daughter's life - FOX 5 Atlanta



Hall County family urges FDA approval for experimental drug to save daughter's life  FOX 5 Atlanta

FDA launches new priority review voucher program for biopharmas that 'align with national priorit...



FDA launches new priority review voucher program for biopharmas that 'align with national priorities'  Fierce Biotech

StockWatch: CGT Stocks Fall on FDA Therapeutic Products Upheaval - Genetic Engineering and Biotec...



StockWatch: CGT Stocks Fall on FDA Therapeutic Products Upheaval  Genetic Engineering and Biotechnology News

Bornstein Seafoods Inc Recalls Cooked & Peeled Ready-To-Eat Coldwater Shrimp Meat Because of Poss...



Bornstein Seafoods Inc Recalls Cooked & Peeled Ready-To-Eat Coldwater Shrimp Meat Because of Possible Health Risk  fda.gov

ProPublica Sued the FDA for Withholding Records About the Safety of Generic Drugs - ProPublica



ProPublica Sued the FDA for Withholding Records About the Safety of Generic Drugs  ProPublica

Drop off unwanted or unused medicines at a drug take-back location - fda.gov



Drop off unwanted or unused medicines at a drug take-back location  fda.gov

Dyne Therapeutics Announces FDA Breakthrough Therapy - GlobeNewswire



Dyne Therapeutics Announces FDA Breakthrough Therapy  GlobeNewswire

FDA announces voucher program to speed drug reviews - CIDRAP



FDA announces voucher program to speed drug reviews  CIDRAP

FDA Approves Powerful Twice-Yearly Treatment to Prevent HIV - WSJ



FDA Approves Powerful Twice-Yearly Treatment to Prevent HIV  WSJ

FDA signs off on Gilead's landmark long-acting PrEP med, signaling new era in HIV prevention - Fi...



FDA signs off on Gilead's landmark long-acting PrEP med, signaling new era in HIV prevention  Fierce Pharma

Outbreak Investigation of Salmonella: Cucumbers (May 2025) - fda.gov



Outbreak Investigation of Salmonella: Cucumbers (May 2025)  fda.gov

As AI device market grows, FDA’s accounting goes silent - STAT



As AI device market grows, FDA’s accounting goes silent  STAT

FDA’s gene therapy turmoil, and an alternative model for funding research - STAT



FDA’s gene therapy turmoil, and an alternative model for funding research  STAT

Parkinson's Discovery Suggests We Could Have an FDA-Approved Treatment Already - ScienceAlert



Parkinson's Discovery Suggests We Could Have an FDA-Approved Treatment Already  ScienceAlert

Bavarian Nordic's $160M FDA speedy review voucher sale shows prices keep rising amid concerns ove...



Bavarian Nordic's $160M FDA speedy review voucher sale shows prices keep rising amid concerns over key program  Fierce Pharma

FDA Approves Merck’s Enflonsia as Rival to Sanofi and AstraZeneca’s Beyfortus in RSV Prevention M...



FDA Approves Merck’s Enflonsia as Rival to Sanofi and AstraZeneca’s Beyfortus in RSV Prevention Market  geneonline.com

FDA Rolls Out Commissioner’s Priority Voucher Program to Speed Drug Reviews - BioSpace



FDA Rolls Out Commissioner’s Priority Voucher Program to Speed Drug Reviews  BioSpace

Cycle Pharmaceuticals’ HARLIKU™ (nitisinone) Tablets Receive First FDA-Approval as Treatment for ...



Cycle Pharmaceuticals’ HARLIKU™ (nitisinone) Tablets Receive First FDA-Approval as Treatment for Alkaptonuria (AKU)  Business Wire

Sanofi, Regeneron Get FDA Approval for Dupixent to Treat Rare Skin Disease - WSJ



Sanofi, Regeneron Get FDA Approval for Dupixent to Treat Rare Skin Disease  WSJ

FDA-Approved Alzheimer’s Drug Lecanemab Shows Reduced Side Effect Concerns in Wider Use - geneonl...



FDA-Approved Alzheimer’s Drug Lecanemab Shows Reduced Side Effect Concerns in Wider Use  geneonline.com

Breaking Down Taletrectinib’s FDA Approval: Jorge J. Nieva, MD - AJMC



Breaking Down Taletrectinib’s FDA Approval: Jorge J. Nieva, MD  AJMC

Gilead Sciences’ Yeztugo receives approval from US FDA for HIV - Pharmaceutical Technology



Gilead Sciences’ Yeztugo receives approval from US FDA for HIV  Pharmaceutical Technology

U.S. judge upholds FDA's removal of Ozempic, Wegovy from drug shortage list - CNBC



U.S. judge upholds FDA's removal of Ozempic, Wegovy from drug shortage list  CNBC

FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain ...



FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain  fda.gov

Front-of-Package Nutrition Labeling - fda.gov



Front-of-Package Nutrition Labeling  fda.gov

FDA warns consumers not to purchase or use any tianeptine product due to serious risks - fda.gov



FDA warns consumers not to purchase or use any tianeptine product due to serious risks  fda.gov

FDA’s gene therapy turmoil unpacked - STAT



FDA’s gene therapy turmoil unpacked  STAT

Avidity Biosciences Secures FDA Agreement for Accelerated Review of FSHD Therapy - geneonline.com



Avidity Biosciences Secures FDA Agreement for Accelerated Review of FSHD Therapy  geneonline.com