FDA

The Readout Elaine Chen

STAT Plus: Intellia says its CRISPR-based therapy can be redosed

First Opinion Tamei Elliott and Maria Vassileva

FDA: Don’t rush publishing your diversity guidance plan. Take your time and do it right

The Readout Elaine Chen

STAT Plus: One firm, two conflicting takes on Alnylam’s HELIOS-B 

First Opinion Andrew D. Forsyth, Mallory O. Johnson, and Jae M. Sevelius

Turning a ‘no’ vote into progress: How to advance MDMA-assisted psychotherapy for PTSD

The Readout Meghana Keshavan

STAT Plus: The findings from Alnylam’s highly anticipated readout  

First Opinion Mark H. Smith

The FDA needs to embrace phage therapy to help fight antimicrobial resistance

Health Elizabeth Cooney

‘We’re failing right now’ in type 2 diabetes, FDA chief says

Biotech Adam Feuerstein

STAT Plus: What the Sarepta decision means for Duchenne patients, the company, and the FDA

Biotech Jason Mast and Matthew Herper

STAT Plus: Top FDA official Peter Marks overruled staff, review team to approve Sarepta gene therapy

Biotech Jason Mast

STAT Plus: FDA approves Sarepta’s Duchenne gene therapy for nearly all patients

Pharmalot Ed Silverman

STAT Plus: Pharmalittle: We’re reading about Lilly lawsuits, Novo Nordisk fires and much more

The Readout Elaine Chen

STAT Plus: Lilly takes more actions against unapproved versions of Mounjaro

Exclusive Casey Ross

STAT Plus: Republican lawmakers criticize FDA’s partnership with CHAI on regulating AI in medicine

Health tech Lizzy Lawrence

STAT Plus: Former medical device CEO who sold fake plastic parts sentenced to 6 years in prison

Health Helen Branswell

New Merck pneumococcal vaccine wins FDA approval

The Readout Meghana Keshavan

STAT Plus: FDA offers new guidelines for Covid-19 vaccine

The Readout Elaine Chen

STAT Plus: J.P. Morgan has officially jumped into early stage biotech investing

Biotech Meghana Keshavan

STAT Plus: FDA gets pointed input on ‘optimizing’ advisory committee panels

The Readout LOUD Adam Feuerstein and Allison DeAngelis

STAT Plus: Listen: Duchenne gene therapy setback, Alzheimer’s drug endorsement & why a STAT reporter buys weed (for journalism)

Biotech Sarah Owermohle, Allison DeAngelis, and Adam Feuerstein

STAT Plus: Biopharma execs cheer Supreme Court for upholding FDA authority in abortion pill case

Politics Sarah Owermohle

STAT Plus: Supreme Court unanimously rejects challenge to mailed abortion pills

The Readout Meghana Keshavan

With Avidity and Pfizer, gene therapy enters a phase

Politics Nicholas Florko

STAT Plus: Senators slam the FDA’s new vape enforcement plan: ‘What in the hell have you been waiting for?’

D.C. Diagnosis Sarah Owermohle

FDA says it’s getting serious about illegal vapes. It’s still likely to get a tongue lashing.

The Readout Meghana Keshavan

The biotech news you missed from the weekend

Health Helen Branswell

STAT Plus: FDA expands approval for GSK’s RSV vaccine to cover younger at-risk adults

The Readout Meghana Keshavan

STAT Plus: Vanda Pharmaceuticals has another suitor

The Readout LOUD Allison DeAngelis and Adam Feuerstein

Listen: Psychedelics at the FDA, ASCO recap, & MorphoSys update

The Readout Elaine Chen

Novavax will be able to supply Covid-19 vaccines this fall