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Regeneron’s Libtayo combination granted FDA approval for non-small-cell lung cancer

The decision was based on superior survival outcomes of Libtayo plus chemotherapy

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Merck’s Keytruda receives NICE recommendation as breast cancer treatment option

Patients will now be able to access immunotherapy at an earlier stage in their treatment journey

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Pfizer’s multiple myeloma treatment granted FDA Breakthrough Therapy Designation

Elranatamab-treated patients achieved an overall response rate of 61% in a phase 2 trial

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Gilead’s Vemlidy gets FDA approval for paediatric patients with chronic hepatitis B infection

The application was supported by positive 24-week data from a phase 2 trial

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GSK’s respiratory syncytial virus older adult vaccine given Priority Review by FDA

There are currently no RSV vaccines approved for older adults anywhere worldwide

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FDA receives Santhera and ReveraGen’s application for Duchenne muscular dystrophy treatment

The submission includes positive data from the pivotal phase 2b and four open-label studies

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GSK’s anaemia drug gets FDA advisory committee support for patients on dialysis

A final decision for daprodustat by the FDA is expected by 1 February 2023

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Janssen’s Tecvayli granted FDA approval for multiple myeloma

A phase 2 study demonstrated an overall response rate of 61.8% in Tecvayli-treated patients

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Merck to donate Sudan Ebola virus vaccine to International AIDS Vaccine Initiative

Around 50,000 doses are expected to be provided for further clinical research use

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AstraZeneca’s Imjudo/Imfinzi combination approved by FDA for unresectable liver cancer

Phase 3 trial results demonstrated a 22% reduction in risk of death versus sorafenib

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Merck’s Prevymis shows promise in phase 3 cytomegalovirus disease prevention trial

The drug demonstrated non-inferior efficacy compared to standard of care valganciclovir

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Novavax’s COVID-19 vaccine candidate approved for emergency use by FDA as a booster

The authorisation is for those unable to receive an FDA-authorised mRNA bivalent booster

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