Biopharma

Fortrea's Alaric Jackson Talks AI in Clinical Trials

Fortrea's CTO discusses AI's expanding role in clinical trials, from discovery t...

Good distribution practice

Good distribution practice

Good manufacturing practice

Good manufacturing practice

Clinical Trials Information System

Clinical Trials Information System

Review of transparency rules for the EU Clinical Trials...

Review of transparency rules for the EU Clinical Trials Information System (CTIS)

VC firm Kineticos launches biotech to develop fresh app...

Venture capital firm Kineticos Life Sciences has launched a new biotech to take ...

German healthcare boss says his business is better bet ...

Generic drugmaker Stada is preparing for what could be Europe’s biggest IPO this...

European Medicines Agency procedural advice for users o...

European Medicines Agency procedural advice for users of the centralised procedu...

European Medicines Agency procedural advice for users o...

European Medicines Agency procedural advice for users of the centralised procedu...

Marketing authorisation application (MAA) - pre-submiss...

Marketing authorisation application (MAA) - pre-submission interactions form

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Xeljanz, tofacitinib, ...

European Medicines Agency pre-authorisation procedural ...

European Medicines Agency pre-authorisation procedural advice for users of the c...

European Medicines Agency pre-authorisation procedural ...

European Medicines Agency pre-authorisation procedural advice for users of the c...

Pre-authorisation guidance

Pre-authorisation guidance

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Neparvis, sacubitril,v...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Entresto, sacubitril,v...

Partnering for success in early phase clinical development

Early-phase clinical trials, including phase 1 and some phase 2a studies, serve ...

Orphan designation: Adeno-associated virus serotype 9 c...

Orphan designation: Adeno-associated virus serotype 9 containing the human RPE65...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Avastin, bevacizumab, ...

Orphan designation: N-(4-(4-amino-5-(3-fluoro-4-((4-met...

Orphan designation: N-(4-(4-amino-5-(3-fluoro-4-((4-methylpyrimidin-2-yl)oxy)phe...

Orphan designation: Arsenic trioxide Treatment of acute...

Orphan designation: Arsenic trioxide Treatment of acute promyelocytic leukaemia,...

STAT+: Fueled by pandemic frustrations, populist partie...

Fueled by pandemic frustrations, populist parties are embracing anti-vaccine fig...

A small study on Covid vaccine safety sparks an online ...

A small study on Covid vaccine safety has sparked an online tempest — and highli...

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

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

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