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Roche’s high-throughput monkeypox test approved for emergency use by FDA

The tests will be conducted on the company’s 6800/8800 cobas systems

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FDA advisory committee recommends Ardelyx’s Xphozah for chronic kidney disease

The phase 3 trials supporting the submission met all primary and key secondary endpoints

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FDA approves ImmunoGen’s Elahere for platinum-resistant ovarian cancer

An overall response rate of 31.7% was demonstrated, including five complete responses

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CDC shows new BQ.1 and BQ 1.1 Omicron subvariants account for 44% of US COVID-19 cases

The two new variants accounted for over 32% of US cases the prior week

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Pfizer/BioNTech BA.4/BA.5 COVID-19 booster receives CHMP recommendation for children five to 11 years

If an authorisation is granted, doses of the bivalent booster will be available to all 27 EU member states

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AZ and Avillion’s asthma rescue treatment recommended by FDA Advisory Committee

PT027 significantly reduced the risk of severe asthma exacerbations

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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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Pfizer and BioNTech dose first patient in COVID-19/flu combination vaccine study

The vaccine aims to protect individuals against two severe respiratory viral diseases

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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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Pfizer’s maternal RSV vaccine candidate shows promise in phase 3 trial

The company stopped the trial early and plans to file for US approval by the end of 2022

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