Biopharma

Vertex axes Verve gene editing pact amid shift in R&D p...

Vertex has backed out of its in vivo gene editing collaboration with Verve Thera...

Silence slows phase 3 plans for cardio drug, as Hansoh ...

“While we remain confident in our zerlasiran program for high Lp(a), we will onl...

Regulatory tracker: FDA starts new review of Regeneron'...

In this tracker, Fierce Pharma is recording the regulatory progress of in-market...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Advagraf, tacrolimus, ...

As Trump targets DEI practices, 4 pharmas reaffirm comm...

Even as President Donald Trump wages a very public fight against diversity, equi...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Omlyclo, omalizumab, D...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Remicade, infliximab, ...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Litfulo, ritlecitinib,...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Welireg, belzutifan, S...

GSK proposes raising chief’s pay to as much as £21.6mn ...

UK drugmaker says Emma Walmsley is underpaid compared with global competitors

Guidance on the details of the classification of variat...

Guidance on the details of the classification of variations requiring assessment...

Infographic - Orphan Medicines in the EU

Infographic - Orphan Medicines in the EU

STAT+: How to eliminate biotech zombies: Buy them

Why one health care investor buys “zombie” biotechs to shut them down.

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Soliris, eculizumab, D...

Opinion: The Trump years will be grim for long Covid su...

The federal government’s work on long Covid has been fitful and disappointing. N...

Opinion: STAT+: There’s a better way to get drugs on th...

A progressive approach to drug approval would balance the reality of drug safety...

STAT+: Why NIH pays universities far more for indirect ...

Universities accept less than their actual overhead costs from private sources b...

STAT+: New kids on the block: A new generation of VCs v...

Biotech venture capital is on the precipice of a generational shift. At least, t...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Spinraza, nusinersen, ...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Xalkori, crizotinib, D...

Addendum to the Guideline on clinical development of va...

Addendum to the Guideline on clinical development of vaccines to address clinica...

Clinical Trial Information System (CTIS) evaluation tim...

Clinical Trial Information System (CTIS) evaluation timelines

Clinical evaluation of new vaccines - Scientific guideline

Clinical evaluation of new vaccines - Scientific guideline

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Voydeya, Danicopan, Da...

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