Infolongevity » FDA on Cell & Gene Therapy

0 Cellular & Gene Therapy Guidances
Approved Cellular and Gene Therapy Products
Cellular & Gene Therapy Products
Cellular, Tissue, and Gene Therapies Advisory Committee
Expanded Access (Compassionate Use)
FDA Digital Health Software Precertification (Pre-Cert) Program
FDA on new policies to advance development of safe and effective cell and gene therapies
Framework for the Regulation of Regenerative Medicine Products
Gene Therapy Legislation in the US
The Process Behing The Making and Approval of New Medicines
What is Gene Therapy? | FDA
2023-06-29 FDA Approves First Gene Therapy for Adults with Severe Hemophilia A
2021-06-08 Member of FDA’s expert panel resigns over Alzheimer’s therapy approval
2021-02-03 As FDA clears flood of AI tools, missing data raise major questions
2020-11-23 FDA Approves First Treatment for Rare Aging Syndrome
2020-08-19 In a shocking decision, FDA rejects BioMarin’s gene therapy for hemophilia
2020-06-24 Update on FDA’s Comprehensive Regenerative Medicine Framework
2020-04-02 Venture-backed Celularity receives FDA approval for early trials of a new cell therapy for COVID-19
2020-01-27 FDA Approves Triple-Combination Drug for Diabetes Glycemic Control
2019-11-05 FDA Official Urges Wealthy Nations to Align Gene Therapy Rules
2019-06-26 How the FDA attempts to force itself on the crucial work of medical practitioners
2019-05-24 FDA approves innovative gene therapy to treat pediatric patients with spinal muscular atrophy
2019-05-12 Scientists Dodge FDA to Offer a $1 Million Anti-Aging Treatment in Colombia
2019-04-02 FDA developing new rules for artificial intelligence in medicine
2019-02-15 FDA advances new efforts to promote development of safe and effective regenerative medicine products
2019-01-17 FDA rejects Immunomedics breast cancer drug, extending long drought
2019-01-15 FDA to beef up cell and gene therapy staff
2019-01-14 BeiGene drug gets ‘breakthrough therapy’ designation from FDA
2019-01-04 FDA grants CRISPR gene therapy fast track designation for sickle cell disease
2018-12-13 Go-ahead for first in-body CRISPR medicine testing
2018-12-04 Zolgensma (AVXS-101) Under Priority FDA Review as Gene Therapy for SMA Type 1
2018-12-03 Global Blood, FDA agree on fast-filing plan for new sickle cell disease drug
2018-11-30 FDA signs off on Editas CRISPR study on patients with a rare genetic disorder
2018-11-26 FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor
2018-11-02 FDA Commissioner Voices Concerns About CAR T-Cell Therapy Payment
2018-10-24 Gottlieb ‘extremely worried’ about how to pay for CAR-T therapies
2018-10-18 Feds crack down on stem cell clinics that touted autism treatments, blindness cures
2018-09-28 FDA Approves Libtayo® as First and Only Treatment for Advanced Cutaneous Squamous Cell Carcinoma
2018-08-30 FDA shows its teeth, biotech fish oil might be pointless & the quest to cure McCain’s cancer
2018-08-21 Landmark FDA Approval Brings Powerful Gene Silencing Method to Market
2018-08-13 Gene-Silencing Technology Gets First Drug Approval after 20-Year Wait
2018-08-10 FDA approval of Alnylam drug is first ever for RNAi-based therapy
2018-08-02 FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
2018-07-11 FDA Commissioner on agency’s efforts to advance development of gene therapies
2018-05-31 The FDA Puts the Brakes on a Major CRISPR Trial in Humans
2018-05-23 Dr. Riam Shammaa on FDA Regulation of Human Cell and Tissue-Based (HCT/Ps) Products
2018-05-14 FDA seeks to shutdown two rogue stem cell clinics
2018-05-14 FDA Targets Clinics Offering Unapproved Stem Cell Therapies
2018-05-09 FDA seeks injunction to stop two stem cell companies after patients blinded
2018-04-19 Hemostemix Announces US FDA Clinical Trial Approval
2018-03-06 23andMe Granted First FDA Authorization for Direct-to-Consumer Genetic Test on Cancer Risk
2018-03-04 New FDA Regenerative Medicine Framework is Win-Win for Gene Therapies
2018-02-26 A New FDA-Approved Gene Therapy Helps Treat a Rare Childhood Cancer
2018-02-15 FDA warns public of dangers of DIY gene therapy
2018-01-30 China might be winning the CRISPR race, but we have the FDA
2018-01-12 FDA roadmap highlights opioids, gene therapy, biosimilars
2018-01-11 Healthy Innovation, Safer Families: FDA’s 2018 Strategic Policy Roadmap
2018-01-09 Gene Therapy Drugs in 2018
2017-12-19 FDA approval for gene therapy marks new era
2017-12-19 FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss
2017-12-19 FDA just approved the first-ever gene therapy for an inherited disease
2017-12-13 Approval of gene therapies for two blood cancers led to an ‘explosion of interest’ in 2017
2017-11-22 FDA warns against ‘do it yourself’ gene therapy kits
2017-11-20 Gene therapy boost: FDA positions for faster reviews of new treatments
2017-11-16 FDA Speeds Review of Gene Therapies, Vowing to Target Rogue Clinics
2017-11-07 The FDA Aims to Relax Regulation on Genetic Tests
2017-11-06 FDA reviews pathway for consumer tests that evaluate genetic health risks
2017-10-20 FDA approves 2nd gene therapy targeting non-Hodgkin lymphomas
2017-10-19 FDA Approves Radical New Gene-Altering Cancer Treatment
2017-10-13 An FDA Panel Approved a Breakthrough Gene Therapy That Fixes Hereditary Blindness
2017-10-13 Why FDA-backed gene therapy for rare form of blindness is revolutionary
2017-09-13 FDA Breaks New Ground With First Approved Gene Therapy for Cancer
2017-09-04 FDA crackdown on unproven stem cell therapies
2017-08-31 A medical breakthrough that hacks genes to fight cancer just got approved
2017-08-31 FDA approves breakthrough CAR-T therapy for leukemia
2017-08-30 CAR-T Therapy For Leukemia Wins FDA Approval
2017-08-30 FDA approval brings first gene therapy to the United States
2017-08-30 FDA Approves First-of-Its-Kind Cancer Treatment
2017-07-12 CAR-T gene therapy for leukemia clears FDA hurdle
2017-07-12 FDA Approves First Gene Therapy To Successfully Treat Cancer
2016-12-19 FDA considering regulation of stem cell clinics
2016-10-13 How are Stem Cells Regulated by the FDA?

FDA on Cell & Gene Therapy

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