Biopharma

Entrada’s 2-year ordeal ends as FDA lifts hold on DMD drug

Entrada Therapeutics is finally able to get its Duchenne muscular dystrophy cand...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Kavigale, sipavibart, ...

Liver transplant specialist OrganOx raises $142M for ti...

The company said its approach has helped cut the number of discarded livers in h...

Lilly banks stockpile of oral GLP-1 drug with potential...

Looking to avoid a repeat of the shortages that plagued Mounjaro and Zepbound du...

FDA approves Medtronic’s adaptive deep-brain stimulator...

The company said its U.S. rollout represents the largest-ever commercial launch ...

Regulatory tracker: Gilead's twice-yearly PrEP injectio...

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

FDA approves first drug for rare lipid storage disease

An approval for the first drug for a rare lipid storage disease, some FDA worker...

Eli Lilly, Novo Nordisk lead revenue boom in the 'alway...

Revenues in the biopharma industry continued to boom in the fourth quarter of la...

Eli Lilly, Novo Nordisk lead revenue boom in the 'alway...

Revenues in the biopharma industry continued to boom in the fourth quarter of la...

STAT+: An awkward moment for Pfizer’s Bourla in Washington

The Pfizer CEO at the White House, CDC vaccine efforts, and other crucial biotec...

A viral vaccine study & rehired FDA employees

In today's Morning Rounds newsletter, a viral vaccine study, rehired FDA employe...

STAT+: Patrizia Cavazzoni, former head of FDA’s drug ce...

Patrizia Cavazzoni, formerly the top regulator of the drug division of the FDA, ...

Opinion: What diagnostic tests can teach about spotting...

If the Trump administration truly wants to reduce waste and fraud in government ...

Pfizer inks deal to test Summit’s white-hot bispecific ...

Pfizer has teamed up with Summit Therapeutics to assess whether one of the indus...

OS Therapies sets up subsidiary to seek ADC joint ventu...

As OS Therapies prepares to take its bacteria-based cancer asset to the FDA for ...

New Approach Methodologies EU-IN Horizon Scanning Report

New Approach Methodologies EU-IN Horizon Scanning Report

STAT+: Pharmalittle: We’re reading about rescinded FDA ...

The Trump administration has started quietly rehiring some of the FDA employees ...

Agenda of the CHMP meeting 24-27 February 2025

Agenda of the CHMP meeting 24-27 February 2025

Annex to 24-27 February 2025 CHMP Agenda

Annex to 24-27 February 2025 CHMP Agenda

Beyond the Diagnosis: Embracing the Humanity Behind Epi...

Hear from UCB’s Brad Chapman on the importance of inclusion, representation, and...

Sanofi shows how $500M bowel disease bet compares to Me...

Sanofi has shared a deeper dive into its 469 million euro bowel disease bet, pub...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Revinty Ellipta, fluti...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Relvar Ellipta, flutic...

5 Market Access Mistakes That Can Derail Your EU Orphan...

Avoid common pitfalls in EU orphan drug market access—learn how local expertise ...

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