Crispr Rallies As The First-Ever Gene-Editing Drug Faces The FDA
The Food and Drug Administration appears likely to approve Crispr Therapeutics' (CRSP) gene-editing approach to sickle cell disease, analysts said Wednesday as CRSP stock gapped higher. The bullish sentiment follows a "relatively benign" FDA advisory committee on Tuesday, Mizuho Securities analyst…#crisprtherapeutics #crsp #fda #mizuhosecurities #salimsyed #gilblum #gilwolfe #universityatbuffalo #leerinkpartners #maniforoohar (Source: Reuters: Health)
Source: Reuters: Health - November 1, 2023 Category: Consumer Health News Source Type: news
FDA Advisors Say New Gene Therapy for Sickle Cell Disease, Exa-cel, is Safe
WEDNESDAY, Nov. 1, 2023 -- A new gene therapy for sickle cell disease was deemed safe by a U.S. Food and Drug Administration advisory panel on Tuesday, paving the way for full approval by early December.
The FDA had already decided that the... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - November 1, 2023 Category: General Medicine Source Type: news
FDA considers first CRISPR gene editing treatment that may cure sickle cell
At age 45, Dr. Lakiea Bailey said, for the longest time, that she was the oldest person with sickle cell anemia that she knew. The executive director of the nonprofit patient advocacy group the Sickle Cell Consortium was diagnosed with sickle cell disease at age three. Because of it, she’s had…#lakieabailey #sicklecellconsortium #bailey #fda #boston #crispr #africanamericans #stephaniekrogmeier #fyodorurnov #independentcommittee (Source: Reuters: Health)
Source: Reuters: Health - November 1, 2023 Category: Consumer Health News Source Type: news
Potential Cure for Sickle Cell Clears Hurdle for Approval
(MedPage Today) -- An FDA advisory committee meeting on Tuesday did nothing to dispel expectations that the investigational agent exagamglogene autotemcel (exa-cel) will become the first approved gene therapy for sickle cell disease (SCD).
Members... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - November 1, 2023 Category: American Health Source Type: news
FDA moves closer to sickle cell cure that uses gene editing
The Food and Drug Administration may be one step closer toward what could be the first approval of a drug that uses the groundbreaking gene-editing tool CRISPR. The drug, called exa-cel, treats sickle cell disease, an inherited blood disorder that affects an estimated 100,000 people in the U.S.,…#bireeandemariam #vertex #crisprtherapeutics #fda #crispr #scotwolfe #lisalee #stateuniversity #josephwu #stephangrupp (Source: Reuters: Health)
Source: Reuters: Health - November 1, 2023 Category: Consumer Health News Source Type: news
CRSP gets FDA panel support for sickle cell treatment
(Source: Reuters: Health)
Source: Reuters: Health - November 1, 2023 Category: Consumer Health News Source Type: news
Panel Tells F.D.A. That CRISPR Sickle Cell Cure Is Safe Enough for Patients
The decision by an advisory committee may lead to Food and Drug Administration approval of the first treatment for humans that uses the CRISPR gene-editing system. (Source: NYT Health)
Source: NYT Health - October 31, 2023 Category: Consumer Health News Authors: Gina Kolata Tags: Sickle Cell Anemia Crispr (DNA) Food and Drug Administration Vertex Pharmaceuticals Inc CRISPR Therapeutics Clinical Trials Genetic Engineering Drugs (Pharmaceuticals) Source Type: news
The FDA is closer to approving a gene-editing treatment for sickle cell disease
The Food and Drug Administration took a crucial step toward approving the first treatment using the revolutionary gene-editing technique known as CRISPR to treat sickle cell disease. (Source: NPR Health and Science)
Source: NPR Health and Science - October 31, 2023 Category: Consumer Health News Authors: Rob Stein Source Type: news
CRISPR Therapeutics Announces Completion of FDA Advisory Committee Meeting for Exagamglogene Autotemcel (exa-cel) for Severe Sickle Cell Disease
Exa-cel PDUFA target action date is December 8, 2023 for severe sickle cell disease (SCD)
ZUG, Switzerland and BOSTON, Oct. 31, 2023 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP) today announced the completion of the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 31, 2023 Category: Drugs & Pharmacology Source Type: news
WATCH LIVE: Sickle cell gene therapy gets review from FDA advisory committee
The only cure for painful sickle cell disease today is a bone marrow transplant. But soon there may be a new cure that attacks the disorder at its genetic source. On Tuesday, advisers to the Food and Drug Administration will review a gene therapy for the inherited blood disorder, which in the U.S.…#fda #crispr #nobelprize #allisonking #stlouis #africa #african #middleeastern #crisprtherapeutics #vertex (Source: Reuters: Health)
Source: Reuters: Health - October 31, 2023 Category: Consumer Health News Source Type: news
New Gene Therapies for Sickle Cell Anemia to be Considered by FDA
MONDAY, Oct. 30, 2023 -- Patients with sickle cell disease may soon have two new treatments to try. On Tuesday, a U.S. Food and Drug Administration advisory committee will weigh the merits of a new gene therapy for the painful, inherited condition.... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - October 30, 2023 Category: Pharmaceuticals Source Type: news
FDA Advisers to Weigh New Gene Therapies for Sickle Cell Anemia
MONDAY, Oct. 30, 2023 -- Patients with sickle cell disease may soon have two new treatments to try. On Tuesday, a U.S. Food and Drug Administration advisory committee will weigh the merits of a new gene therapy for the painful, inherited condition.... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - October 30, 2023 Category: Pharmaceuticals Source Type: news
F.D.A. Experts Will Vote on Safety of a Cure for Sickle Cell Disease
The treatment from the company Vertex would be the first medicine to use the gene editing tool CRISPR. (Source: NYT Health)
Source: NYT Health - October 30, 2023 Category: Consumer Health News Authors: Gina Kolata Tags: Sickle Cell Anemia Food and Drug Administration Crispr (DNA) Vertex Pharmaceuticals Inc Genetic Engineering Drugs (Pharmaceuticals) Therapy and Rehabilitation CRISPR Therapeutics Source Type: news
FDA Reviewers Question Safety of Sickle Cell Gene Therapy
(MedPage Today) -- Whether the investigational sickle cell disease therapy exagamglogene autotemcel (exa-cel) has adequately proven that it won't produce off-target genetic changes was questioned by FDA reviewers ahead of an advisory committee... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - October 30, 2023 Category: American Health Source Type: news
FDA Advisors to Weigh New Gene Therapy for Sickle Cell Anemia
MONDAY, Oct. 30, 2023 -- Patients with sickle cell disease may soon have two new treatments to try.On Tuesday, a U.S. Food and Drug Administration advisory committee will weigh the merits of a new gene therapy for the painful, inherited... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - October 30, 2023 Category: General Medicine Source Type: news
