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 ...
European committee takes a second look at Alzheimer's drug and now says it should be approved
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
Bristol Myers faces renewed, $6.7 bln lawsuit over delayed cancer drug
Bristol Myers Squibb was hit on Thursday with a $6.7 billion lawsuit claiming it cheated former Celgene shareholders by ...
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 ...
Cure Today18m
FDA Approves Danziten for Leukemia Subset That Does Not Require Fasting
Danziten, a new formulation of nilotinib, may improve treatment adherence in patients with Philadelphia chromosome-positive ...
Targeted Oncology3h
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 grants orphan drug designation to potential treatment of STXBP1 developmental and epileptic encephalopathy
Research that was carried out by Baylor College of Medicine and Texas Children's Hospital doctors has led to the U.S. Food ...
The American Journal of Managed Care19h
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 ...
BioPharma Dive21h
PTC wins US approval of gene therapy for fatal enzyme disorder
Kebilidi is the first approved gene therapy that can be directly administered to the brain. Its OK secures a priority review ...
RFK Jr. pick sparks FDA concerns
Robert F. Kennedy Jr.’s selection Thursday as President-elect Donald Trump’s Health and Human Services secretary nominee sent shockwaves through Washington.
Regeneron, Sanofi announce FDA accepts Dupixent sBLA for review
Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the resubmission of the supplemental Biologics License ...