SurvivorNet on MSN2d
New CML Approval: Leading Leukemia Expert on the ‘Significant Improvement’ Asciminib (Scemblix) Offers Patients as a First-Line Treatment Option
For chronic myeloid leukemia (CML) patients, there is a promising new first-line drug approval with asciminib (brand name ...
HealthDay on MSN37m
FDA Approves Cobenfy for Adults With Schizophrenia
The U.S. Food and Drug Administration has approved Cobenfy (xanomeline and trospium chloride), a first-in-class muscarinic ...
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 ...
European watchdog partially approves new Alzheimer's drug
Europe's medicines watchdog on Thursday partially approved a marketing request for a long-awaited new treatment for Alzheimer ...
Sino Biopharmaceutical Gains FDA Approval for New Cancer Drug
Sino Biopharmaceutical (HK:1177) has released an update. Sino Biopharmaceutical has received approval from the U.S. FDA to commence Phase I ...
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, ...
MedPage Today3d
FDA Rejects Full Approval of Liver Disease Drug
Opens in a new tab or window Share on X ... Notably, the FDA this year granted accelerated approval to two other drugs -- ...
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 ...
News Medical1d
The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development
If companies fail to promptly undertake confirmatory trials post-approval, this could compromise the robustness of evidence ...
Targeted Oncology11h
FDA Approval Sought for Dato-DXd in EGFR-Mutated NSCLC
A new BLA for datopotamab deruxtecan aims for FDA accelerated approval to treat EGFR-mutated NSCLC based on data from ...
‘Do your research’: Pet owner warns others after linking cat’s death to new arthritis drug
Some pet owners want a recall of a new arthritis drug for cats after their animals died, some in horrific ways, just days ...