Syndax Pharmaceuticals Leukemia Drug Wins a First-in-Class FDA Approval
Syndax Pharmaceuticals has won FDA approval for a drug addressing advanced cases of acute leukemia carrying a particular genetic signature ...
Tag: Approval
PTC Therapeutics Wins First FDA Approval for a Gene Therapy Dosed Directly Into the Brain
An ultra-rare enzyme deficiency that keeps infants from achieving proper muscle function among other developmental delays now has its first ...
Astellas Pharma Lands a First-in-Class Drug Approval in Rare Gastrointestinal Cancer
An Astellas Pharma drug designed to address a novel target has landed a highly anticipated FDA approval for a rare ...
Sanofi and Regeneron Biologic Drug Dupixent Notches a New FDA Approval in COPD
The blockbuster Sanofi and Regeneron Pharmaceuticals drug Dupixent, already commercialized in several skin and lung disorders, has expanded its FDA-approval ...
FDA Approval of Bristol Myers Drug Makes It the First Novel Schizophrenia Med in Decades
Schizophrenia is currently treated with older medications with limited efficacy and troublesome side effects that lead many patients to stop ...
WHO grants first mpox vaccine approval to ramp up response to disease in Africa and beyond
A health worker attends to an mpox patient, at a treatment center in Munigi, eastern Congo, Aug. 19, 2024. Credit: ...
Subtle Medical receives Phase II funding approval to boost imaging technology
AI-powered medical imaging company Subtle Medical was awarded Phase II funding of its NIH small business innovation research (SBIR) grant ...
Time from drug approval to reimbursement longer in U.S. than some european countries
Time from approval to reimbursement of new drugs varies between countries and is shortest in Switzerland and Germany, both of ...
WELL Health receives approval for $44M digital project
WELL Health, a digital health company that integrates and updates clinical and digital assets, announced the approval of a $44 ...
FDA: withdraw approval of more than tainted 400 drugs
When the FDA learned that a testing facility in India had submitted fraudulent data for more than 400 drugs (most ...
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