The Pharma Letter2 天
FDA panel votes against broader use of checkpoint blockers
A US Food and Drug Administration advisory committee meeting has recommended restricting the use of PD-1 inhibitors, in a ...
Column: A federal appeals court hands the FDA a stupendous win in its battle against stem ...
The FDA claimed these clinics were plying patients with an illegal drug derived from their stem cells. A federal court agrees ...
Courthouse News Service2 天
Ninth Circuit sides with FDA in oversight of ‘liquid magic’ stem cell therapy
The panel agreed with the FDA that the treatment in which a patient's tissue is processed doesn't fall under the same ...
Applied Therapeutics: FDA Stance Change For Advisory Panel Bodes Well For Review
Update on FDA's Applied Therapeutics, Inc. decision to remove advisory panel for govorestat review in treating galactosemia.
Applied Therapeutics Stock Soars As FDA Scraps Panel Meeting For Its Inherited Metabolic ...
Applied Therapeutics, Inc. (NASDAQ:APLT) stock traded higher with a session volume of 31.75 million, compared to an average ...
FiercePharma3 天
UPDATED: Experts support FDA's plan for restrictions on PD-1 drugs in stomach, esophageal ...
The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered.  | The days of broad stomach cancer labels ...
J&J builds case for Talvey; FDA panel questions PD-1 drugs for certain cancers
New data show Talvey’s potential in multiple myeloma drug combinations. Elsewhere, AbbVie got more positive Parkinson’s drug ...
Unpacking the FDA’s non-recall recalls
The FDA and manufacturers routinely allow doctors and hospitals to continue using medical devices that could cause serious ...
STAT6 天
Millions of Americans want to quit smoking. Critics say drugmakers and the FDA are failing them
There hasn’t been a new class of drugs approved to help smokers quit since Pfizer's Chantix reached the market nearly two ...
SeafoodSource4 天
SENA Panel: Everyone’s Targeting Seafood – CBP Forced Labor, Proposition 65, PFAS, and FDA
An on-demand video of “Everyone’s Targeting Seafood – CBP Forced Labor, Proposition 65, PFAS, and FDA” is available free for ...
T2 Biosystems Receives FDA Clearance to Market the T2Candida Panel for Pediatric Patients
The T2Candida Panel is the only FDA-cleared diagnostic test able to detect sepsis-causing Candida species directly-from-blood, in just 3-5 hours, without the need to wait days for a positive blood ...
FDA批准T2 Biosystems儿科脓毒症检测
马萨诸塞州列克星敦 - T2 Biosystems, Inc. (NASDAQ:TTOO) 宣布其T2Candida Panel检测获得FDA批准用于儿科患者。这项直接从血液样本中检测引起脓毒症的念珠菌的诊断测试现在可以在美国各儿童医院进行销售和使用。T2Candida Panel以其快速结果而闻名,可在3-5小时内提供检测结果,相比可能需要数天的传统血培养方法有显著改进。 T2Candida P ...