The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Moderna’s Covid-19 vaccine, Spikevax, for adolescents aged 12 to 17 years.
Merck and Eisai have secured approval from the US Food and Drug Administration (FDA) for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) combination to treat patients with certain types of advanced endometrial carcinoma.
AstraZeneca has completed the acquisition of biopharmaceutical company Alexion Pharmaceuticals in a deal valued at $39bn.
Roche has received Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for its Ronapreve to treat mild to moderate Covid-19 patients.
The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) and granted priority review for tezepelumab, which is being developed by AstraZeneca and Amgen, to treat patients with asthma.
The European Commission has cleared AstraZeneca’s proposed acquisition of Alexion Pharmaceuticals for $39bn.
Seres Therapeutics and Nestlé Health Science have signed an agreement to jointly commercialise SER-109, an investigational oral microbiome therapy, in the US and Canada.
Novartis has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for 177Lu-PSMA-617 to treat metastatic castration-resistant prostate cancer (mCRPC).
Biotechnology company Moderna has secured approval from the European Medicines Agency’s (EMA) committee for human medicines (CHMP) for a new Covid-19 vaccine manufacturing site in Monts, France.
Ocugen has announced plans to seek full approval from the US Food and Drug Administration (FDA) for Covid-19 vaccine candidate, Covaxin.
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