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- PMLiVE

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- 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

- PMLiVE

UPDATE: US pauses rollout of J&J’s COVID-19 vaccine amid reports of rare blood clots

An advisory committee to the CDC recommended extending the pause in the US to review additional data

- PMLiVE

J&J’s multiple sclerosis therapy Ponvory moves closer to EU approval

CHMP issues a positive opinion for S1P1 modulator based on positive phase 3 results

- PMLiVE

J&J’s MS drug ponesimod receives approval in the US

US regulator has approved the drug – now named Ponvory – for relapsing forms of MS

- PMLiVE

WHO backs emergency use of J&J’s one-dose COVID-19 vaccine

Vaccine is already approved for emergency use by the European Commission and the FDA

- PMLiVE

J&J’s one-dose COVID-19 vaccine granted EU authorisation

Company aiming to begin vaccine delivery to EU in the second half of April

- PMLiVE

Pfizer/BioNTech could supply three billion doses of COVID-19 vaccine in 2022

J&J reportedly facing vaccine supply issues in the EU

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