Biopharma

Regulation (EU) 2024/568: Questions and answers clinic ...

Regulation (EU) 2024/568: Questions and answers clinic for the Veterinary Indust...

Galapagos drops one CD19 CAR-T to focus on 'flagship' p...

Galapagos is dropping its junior CD19 CAR-T as part of the Belgian biotech’s see...

Minutes - PDCO minutes of the 10-13 December 2024 meeting

Minutes - PDCO minutes of the 10-13 December 2024 meeting

EMEA-003437-PIP01-23

EMEA-003437-PIP01-23

EMEA-003486-PIP01-23

EMEA-003486-PIP01-23

EMEA-003490-PIP01-23

EMEA-003490-PIP01-23

EMEA-003386-PIP01-22

EMEA-003386-PIP01-22

EMEA-003421-PIP01-23

EMEA-003421-PIP01-23

EMEA-003488-PIP01-23

EMEA-003488-PIP01-23

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Locametz, gozetotide, ...

STAT+: Biotech is in a dark place

Biotech and drug stocks, collectively, are down an average of 16% over the past ...

Opinion/decision on a Paediatric investigation plan (PI...

Opinion/decision on a Paediatric investigation plan (PIP): Omvoh, Mirikizumab, d...

EMEA-002329-PIP02-20-M03

EMEA-002329-PIP02-20-M03

EMEA-002798-PIP04-23

EMEA-002798-PIP04-23

Opinion/decision on a Paediatric investigation plan (PI...

Opinion/decision on a Paediatric investigation plan (PIP): Uplizna, Inebilizumab...

Sanofi takes $250M hit after gamble on J&J E. coli vacc...

A year and a half after Sanofi swooped in on Johnson & Johnson’s dismantled vacc...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Xaluprine (previously ...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Lydisilka, estetrol,dr...

Opinion: The FDA must remove an unnecessary barrier to ...

If the FDA follows an advisory committee’s vote, it can potentially be a transfo...

Opinion: How to close America’s life expectancy gap

The U.S. ranks 29th in life expectancy at birth among peer nations in the OECD. ...

As officials prepare for WHO-led flu vaccine meeting, m...

Each year, flu experts from around the world gather to map out recommendations f...

Young researchers mobilize to protest Trump administrat...

Stunned by attacks on the scientific research system, early career scientists pl...

Implementation strategy of ICH Guideline M12 on drug in...

Implementation strategy of ICH Guideline M12 on drug interaction studies

ICH M12 on drug interaction studies - Scientific guideline

ICH M12 on drug interaction studies - Scientific guideline

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