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- PMLiVE

product withdrawal

- PMLiVE

Pfizer, BioNTech to submit emergency use request for COVID-19 vaccine to FDA today

Shot could be available for high-risk populations in the US by middle of December

- PMLiVE

FDA delays BMS’ liso-cel decision, citing COVID-19 travel restrictions

Inspection of third-party manufacturing plant delayed due to COVID-19

- PMLiVE

FDA set to publish reviews of data relating to COVID-19 vaccine EUAs

Agency set to publish data as part of 'transparency' efforts

- PMLiVE

FDA advisory committee overwhelmingly votes no on Biogen’s aducanumab

Path to approval looks increasingly difficult for potential Alzheimer’s treatment

- PMLiVE

EMA will assess potential COVID-19 vaccine on ‘case by case’ basis

Agency will not specify a minimum level of efficacy, according to Reuters

- PMLiVE

FDA briefing documents back Biogen’s Alzheimer’s drug aducanumab

Documents show the efficacy data for the drug as being ‘exceptionally persuasive’

- PMLiVE

The Unknown Unknowns

Patient insights are fundamental to ensuring we understand the reality of living with a condition. We need to consciously  challenge our approach and ensure we are unearthing authentic patient insights that...

Bedrock Healthcare Communications

- PMLiVE

COVID-19 vaccine developers won’t face pre-approval FDA inspections for EUAs

Companies typically face inspections before gaining approval from the FDA

- PMLiVE

Vaccine developers call on FDA to offer clarity on COVID-19 trials

Comments from J&J and Pfizer made before FDA advisory committee meeting yesterday

- PMLiVE

Independent consultant will review Lilly’s COVID-19 plant issues

COVID-19 antibody trial was paused last week due to safety issue

- PMLiVE

Regeneron scores first FDA approval for Ebola antibody treatment

Treatment cut mortality rate in study based in the Democratic Republic of Congo

- PMLiVE

Regeneron seeks US emergency use authorisation for COVID-19 antibody cocktail

If approved, the US government will make initial doses available at no cost

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