RFK Jr. vow to purge FDA sets up collision with Big Pharma
Kennedy has been most vocal about the FDA, an agency that oversees nearly $3 trillion in medicines, food and tobacco products ...
Targeted Oncology12m
FDA Approves Nilotinib With No Mealtime Restrictions in Ph-Positive CML
The FDA has approved a re-engineered formulation of nilotinib with no mealtime restrictions for adult patients with newly ...
FDA approves Cobenfy for adults with schizophrenia
The U.S. Food and Drug Administration has approved Bristol Myers Squibb's Cobenfy (xanomeline and trospium chloride), a first ...
Reuters1d
US FDA approves PTC Therapeutics' gene therapy for ultra-rare disorder
Nov 13 (Reuters) - The U.S. Food and Drug Administration approved PTC Therapeutics' (PTCT.O), opens new tab gene therapy to ...
US FDA declines full approval for Intercept's liver disease drug
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
FDA approves Emrosi for rosacea in adults
The U.S. Food and Drug Administration has approved Journey Medical's Emrosi (minocycline hydrochloride) for the treatment of ...
Repurposed FDA-approved drug could uncover potential treatment for rare genetic disorders
In a new study, researchers at McMaster University have identified a potential treatment for Sandhoff and Tay-Sachs ...
The American Journal of Managed Care23h
FDA Approves Gene Therapy to Treat AADC Deficiency
The approval marks the first time gene therapy will be available to treat patients with aromatic I-amino acid decarboxylase ...
The American Journal of Managed Care16h
FDA Approves Danziten for Chronic Myeloid Leukemia Without Mealtime Restrictions
The FDA has granted approval to Azurity Pharmaceuticals' nilotinib tablets (Danziten), a novel version of the tyrosine kinase ...
FiercePharma1d
PTC wins FDA approval for first brain-delivered gene therapy Kebilidi
The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy ...
FiercePharma2d
FDA rejects Intercept's ask for Ocaliva full nod in rare liver disease, but accelerated approval remains
In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...