Biopharma

Manufacturing issues trip up Milestone's long-awaited F...

The FDA has rejected Milestone Pharmaceuticals’ application for approval of Card...

EU regulator declines approval for Eli Lilly’s new Alzh...

European Medicines Agency says risks of potentially fatal side effects from dona...

Chutes & Ladders—Yet another exec departs CRISPR

CRISPR Therapeutics’ Julianne Bruno is hitting the exit in favor of external opp...

STAT+: Eli Lilly’s Alzheimer’s drug gets thumbs down ...

Eli Lilly's Kisunla was approved in the U.S. for Alzheimer's last year, but now ...

BioNTech shows off lung cancer survival data behind pha...

BioNTech has shown why it made small cell lung cancer a priority for its PD-L1xV...

Template for response to list of questions/list of outs...

Template for response to list of questions/list of outstanding issues: Quality /...

STAT+: Novo Nordisk sets sights on new type of oral obe...

Novo Nordisk has licensed an oral obesity drug that works via an uncommon mechan...

Day 80 assessment report - Non-clinical template with g...

Day 80 assessment report - Non-clinical template with guidance Rev. 03.25 - Revamp

Novo inks $1B biobucks Lexicon obesity deal after seein...

Lexicon Pharmaceuticals’ pursuit of the last word in obesity candidates has attr...

Spero halts development on another antibiotic in latest...

Having stripped back its workforce, antibiotics biotech Spero Therapeutics conti...

EMA concludes review of weight management medicine Mysimba

EMA concludes review of weight management medicine Mysimba

Summary of opinion: Pemazyre, 27/03/2025 Negative

Summary of opinion: Pemazyre, 27/03/2025 Negative

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Qoyvolma, ustekinumab,...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Jubereq, denosumab, St...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Ryjunea, Status: Opinion

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Kisunla, donanemab, St...

Referral: Mysimba, naltrexone,bupropion Article 20 proc...

Referral: Mysimba, naltrexone,bupropion Article 20 procedures CHMP opinion, 27/0...

Summary of opinion: Calquence, 27/03/2025 Positive

Summary of opinion: Calquence, 27/03/2025 Positive

Meeting highlights from the Committee for Medicinal Pro...

Five new medicines recommended for approvalEMA’s human medicines committee (CHMP...

Withdrawn application: Amyvid, 26/02/2025

Withdrawn application: Amyvid, 26/02/2025

Summary of opinion: Bosulif, 27/03/2025 Positive

Summary of opinion: Bosulif, 27/03/2025 Positive

Summary of opinion: Tremfya, 27/03/2025 Positive

Summary of opinion: Tremfya, 27/03/2025 Positive

Summary of opinion: Tevimbra, 27/03/2025 Positive

Summary of opinion: Tevimbra, 27/03/2025 Positive

Summary of opinion: Flucelvax, 27/03/2025 Positive

Summary of opinion: Flucelvax, 27/03/2025 Positive

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