Biopharma

STAT+: Trump taps MAHA influencer for surgeon general, ...

This is the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about ...

In first oncology expert meeting under Makary, FDA spot...

The head of the FDA’s oncology department, Richard Pazdur, M.D., is now the only...

STAT+: Democrats urge Republicans to target Medicare Ad...

Republicans are considering deep cuts to Medicaid to pay for tax cuts. Democrats...

Viatris’ new form of old pain drug scores in large trials

A version of meloxicam designed to work faster has beat out a placebo in two lat...

Who we are

Who we are

Trump to sign 'most favored nation' executive order to ...

After failing in his first term to install a most favored nation plan to reduce ...

Careers

Careers

EMA Gender equality plan 2025 - 2030

EMA Gender equality plan 2025 - 2030

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Neupro, rotigotine, Da...

NIH grant terminations under Trump have totaled at leas...

Researchers calculated that $1.8 billion in National Institutes of Health grants...

Takeda looks toward 'inflection point' as it eyes new l...

The company has three key phase 3 readouts this year, which it hopes will contri...

Why RFK Jr.’s data plans might hit a real world snag

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to ho...

European Medicines Agency Write PMS API implementation ...

European Medicines Agency Write PMS API implementation Guide (zip)

FDA Announces Completion of First AI-Assisted Scientifi...

FDA announced an aggressive timeline to scale AI across all centers by June 30.

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Tuzulby, methylphenida...

Supporting innovation

Supporting innovation

Gilead, bracing for tariffs, joins peers in US drug pro...

The company added to a recent flurry of pledges by pharmaceutical companies, pro...

Process for the electronic submission of medicinal prod...

Process for the electronic submission of medicinal product information - Chapter 3

Draft qualification opinion for Simcyp Simulator

Draft qualification opinion for Simcyp Simulator

Opinions and letters of support on the qualification of...

Opinions and letters of support on the qualification of novel methodologies for ...

Amneal bolsters US manufacturing capacity with Apiject ...

Amneal Pharmaceuticals inked a collaboration deal with syringe maker Apiject tha...

Questions and answers for biological medicinal products

Questions and answers for biological medicinal products

Biotech is guessing how Vinay Prasad might change the F...

Across hundreds of published papers, CBER’s new chief has argued for more string...

Cancer before age 50 is increasing. A new study looks a...

Cancer before age 50 is increasing. A new government study provides the most com...

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