STAT4h
Sanofi is warned by the FDA over ‘significant’ problems at a key manufacturing plant
The FDA has warned Sanofi about a series of “significant” manufacturing problems, including contamination, at a key facility ...
UVA Today4h
FDA Bans Red Dye No. 3 in Food, Decades After Banning It in Cosmetics
T he U.S. Food and Drug Administration has banned the use of red dye No. 3 in foods, more than three decades after ...
Atara extends losses after FDA clinical hold
Atara Biotherapeutics (ATRA) stock slips as company faces an FDA clinical hold after rejection of lead candidate Ebvallo.
US FDA puts clinical hold on Atara's trials for cancer cell therapies
Atara Biotherapeutics said on Tuesday the U.S. health regulator has placed a clinical hold on its trials for cancer cell therapies, sending the drug developer's shares down more than 4% in premarket ...
Atara's New Drug Applications Placed on Hold by FDA
Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications. The biotechnology company said the FDA put a hold on its ...
Solid Biosciences' Ataxia Treatment Receives FDA Fast-Track Designation
Fast-track status will allow Solid Biosciences to have more frequent meetings with the FDA throughout the treatment-development process and, potentially, get the product to patients faster than would ...
Solid Biosciences Receives FDA Fast Track Designation for SGT-212 Dual Route of Administration Gene Therapy for Friedreich’s Ataxia
Only dual route gene transfer therapy in development to treat Friedreich’s ataxia with FDA IND clearance and Fast Track designation ...
Solid Biosciences gets FDA Fast Track for FA gene therapy
CHARLESTOWN, Mass. - Solid Biosciences Inc. (NASDAQ:SLDB), a $130.65 million market cap biotechnology company, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) ...
ConsumerAffairs4h
Minnesota sues e-cigarette manufacturer and investigates another
Minnesota Attorney General Keith Ellison has filed a lawsuit against High Light Vapes, a Los Angeles-based e-cigarette ...
The National Law Review8h
FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued ...
FiercePharma10h
Atara's Ebvallo and pipeline candidate put on clinical hold in US after partner's failed plant inspection
After receiving a complete response letter last week, the other shoe has dropped for Atara Biotherapeutics and its pipeline ...
FDA Places Clinical Hold On Atara Biotherapeutics' Two Cell Therapy Programs
FDA halts Atara's EBVALLO and ATA3219 trials over manufacturing issues. Atara eyes $60 million milestone from Pierre Fabre upon EBVALLO approval.