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FDA approval for Keytruda/Herceptin combination in first-line advanced gastric cancer

Approval is based on positive overall response rate (ORR) data from KEYNOTE-811 trial

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AZ, Sanofi’s nirsevimab hits primary endpoint in RSV trial

Drug reduced lower respiratory tract infections caused by respiratory syncytial virus in infants

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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

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GSK wins approval for anti-PD-1 antibody Jemperli in endometrial cancer

AnaptysBio earns a $20m milestone payment on approval after originally developing the drug

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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”

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Second Sarclisa combination regimen for multiple myeloma approved in EU

Second indication for Sarclisa covers drug’s use in combination with another standard myeloma treatment

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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

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Sanofi pays $160m upfront to acquire Tidal Therapeutics

French pharma company's acquisition of pre-clinical stage biotech includes mRNA-based research platform

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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

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FDA accepts BMS’ investigational cardiovascular drug mavacamten for review

BMS gained the rights to mavacamten as part of its acquisition of MyoKardia

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Sanofi and Translate Bio launch phase 1/2 trial of mRNA-based COVID-19 vaccine

Vaccine candidate induced high antibody levels in preclinical studies

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Sanofi, Regeneron’s Libtayo shows marked reduction in risk of death in cervical cancer patients

Phase 3 trial showed drug reduced the risk of death by 31% compared to chemotherapy

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