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- PMLiVE

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- PMLiVE

FDA leaders offer perspective on accelerated approval of Biogen’s Aduhelm

Leaders maintain that Aduhelm fits into the regulatory paradigm of the FDA’s accelerated approval pathway

- PMLiVE

FDA questions safety profile of AZ, FibroGen’s anaemia drug roxadustat

AZ and FibroGen are aiming for approval of roxadustat in anaemia caused by chronic kidney disease

- PMLiVE

FDA lists rare neurological condition as potential side effect of J&J’s COVID-19 vaccine

Guillain-Barré syndrome has been reported in 100 people who have received the vaccine in the US

- PMLiVE

FDA acting commissioner Janet Woodcock requests independent review of Aduhelm approval

Approval of Biogen's Alzheimer's disease treatment has raised concerns over FDA staff interactions with the company

- PMLiVE

Pfizer, BioNTech eye US approval for COVID-19 booster dose

Companies plan to request an emergency use authorisation from the FDA for the booster dose in August

- PMLiVE

J&J’s COVID-19 vaccine shows ‘strong’ activity against Delta variant

Vaccine produces durable immune responses lasting up to eight months

- PMLiVE

FDA priority review granted for J&J, Legend Biotech’s myeloma CAR T therapy

CAR T therapy demonstrated an overall response rate of 97% in relapsed/refractory multiple myeloma patients after 12.4 months

- PMLiVE

J&J resumes US rollout of single-dose COVID-19 vaccine

CDC and FDA recommended pause be lifted after ‘rigorous review’ of very rare blood clots

- PMLiVE

J&J halts manufacturing of COVID-19 at US plant after FDA warning

Inspection report found facility was “not maintained in a clean and sanitary condition”

- PMLiVE

EMA finds overall benefit-risk ‘remains positive’ for J&J COVID-19 vaccine

Safety committee finds possible link to ‘very rare cases’ of unusual blood blots with low blood platelets

- PMLiVE

Janssen will not seek regulatory approval for Erleada plus Zytiga in prostate cancer

Decision follows mixed results from the phase 3 ACIS study

- PMLiVE

J&J delays EU COVID-19 vaccine rollout following pause in the US

FDA and CDC recommended pausing rollout in US after reported cases of rare blood clots in vaccinated individuals

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