News

Scotland faces up to its drug crisis by offering the UK’s first supervised injection facility
In a quiet corner of Glasgow’s East End, a radical public health experiment is underway. For the first time in the United ...
FDA to consider drug affordability when granting new vouchers to speed up approvals, Makary says
It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...
Stocktwits on MSN1h
Capricor Stock Plunges Pre-Market After US FDA Declines Approval For Muscular Disorder Therapy
Capricor Therapeutics (CAPR) on Friday said the U.S. Food and Drug Administration (FDA) has refused to approve its lead cell ...
FDA Commissioner: ‘We want to focus on food’
Makary, a surgical oncologist tapped by President Trump to serve as the the 27th FDA chief, joined NewsNation on Thursday to ...
Fierce Biotech52m
FDA rejects Capricor’s DMD cell therapy, asks for more data
The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy (DMD) cell therapy, raising ...
STAT1h
Questions about the FDA’s ‘radical transparency’ efforts
Happy Friday. Today, we talk about the stem cell fire sale at CIRM, and about the FDA’s move to release a limited batch of ...
FDA publishes full texts of response letters to drug applications
The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...
25 hospitalized after suspected mass overdose in West Baltimore; drug not yet known
Police and fire responded to a neighborhood "in reference to multiple individuals experiencing overdose symptoms".
STAT2h
FDA rejects Capricor’s cell therapy for Duchenne muscular dystrophy
The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment ...
BioSpace2h
FDA’s Rejections: We Read 200 CRLs So You Don’t Have To
A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...
The Culprit Impeding Drug Competition Is Not Who The Feds Expected
There's little point in pouring hundreds of millions of dollars into creating a biosimilar if PBMs will refuse to cover it.
FDA mulls faster drug reviews in exchange for lower prices in U.S.- Bloomberg
FDA Commissioner Marty Makary suggests his agency may expedite drug reviews for manufacturers reducing U.S. prices to global ...