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2 medical device recalls to know
The FDA has flagged two Class I medical device recalls and corrections, affecting blood glucose monitors and insulin pumps. Here are two recalls to know: The post 2 medical device recalls to know appeared first on …
Read full story →FDA approves new Alzheimer’s agitation treatment
The FDA has approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) to treat agitation associated with dementia …
STAT+: Axsome wins FDA nod for Alzheimer’s agitation
Vinay Prasad's acting replacement, remembering genomics pioneer J. Craig Venter, and more biotech news from The Readout
Peptides are unproven as health aids. FDA may unleash them anyway
Rather than reining in the compounds, the FDA may be poised to broaden access, perhapas even adding peptides to supplements. …
STAT+: Pharmalittle: We’re reading about obesity drugs and a compounding list, an AstraZeneca setback, and more
The FDA proposed excluding the active ingredients in popular obesity and diabetes drugs from a list of substances that can …
ECRI Urges Congress to Strengthen Regulatory Transparency for Digital Health and CDS Tools
What You Should Know ECRI, a nonprofit patient safety organization, submitted formal recommendations to the House Energy and Commerce Subcommittee …
Axsome receives FDA approval for Auvelity to treat Alzheimer’s agitation
Axsome Therapeutics has received FDA approval for Auvelity to treat agitation associated with dementia due to Alzheimer’s.
‘Forever chemicals’ in baby formula? Scientists unpack FDA results
FDA review confirmed overall safety of 16 brands of baby formula. In a STAT Q&A, experts unpack what low-level PFAS …
STAT+: Katherine Szarama named acting director of FDA’s vaccines and biologics center
Katherine Szarama, who joined the FDA last year to serve as Vinay Prasad’s deputy, will now fill his shoes at …
FDA approval, fundraising, and the reality of building in healthcare according to BioticsAI founder | TechCrunch
BioticsAI CEO Robhy Bustami joined Isabelle Johannessen on Build Mode to discuss how the company has navigated a highly regulated …
FDA seeks to restrict compounding of key GLP-1s
The FDA has proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, the latest move in a monthslong …
STAT+: Hinge has a new FDA-cleared migraine device
In this edition of STAT Health Tech: FDA's plan to use AI to speed up trials, Hinge's new migraine device, …
STAT+: FDA wants to exclude weight-loss drugs from a compounding list
FDA moves to remove semaglutide, tirzepatide, and liraglutide from its 503B compounding list, saying there's no shortage of GLP-1 drugs …
Bayer earns FDA untitled letter for Nubeqa's 'attention-grabbing visuals'
The FDA has reprimanded Bayer for the “attention-grabbing visuals” and “frequent scene changes” in ads for the company’s prostate cancer …
FDA Announces Real-Time Clinical Trial Pilot Program and Proof-of-Concept Studies with AstraZeneca and Amgen
What You Should Know The FDA has launched two proof-of-concept (PoC) real-time clinical trials (RTCT) that report endpoints and data …
US infant formula supply is 'safe,' FDA says after looking for potential contaminants
Federal health officials said a new analysis of U.S. infant formula found reassuringly low levels of heavy metals, pesticides and …
FDA affirms safety of infant formula from heavy metals
The U.S. infant formula supply is largely safe from contaminants, according to new testing results announced Wednesday by the Food …
Chiesi Group Grows Again in Rare Disease With $1.9B KalVista Acquisition
KalVista Pharmaceuticals brings to Chiesi Group the product Ekterly, the first FDA-approved oral drug for acute treatment of swelling attacks …
Infant formula largely safe from heavy metals, FDA finds
FDA sampled 312 major infant formula brands and found low or undetectable levels of pesticide residue, PFAS, heavy metals and …
STAT+: A patent win for Pfizer and BridgeBio
A change to FDA clinical trial data review, Rocket sells its priority review voucher, and more biotech news from The …
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