Pfizer and its partner BioNTech have submitted the initial data of an early-stage trial to the US Food and Drug Administration (FDA) to support the authorisation of a booster dose of their Covid-19 vaccine.
Merck, called MSD outside the US and Canada, has initiated a rolling submission to Health Canada for molnupiravir, an investigational oral antiviral therapy for the treatment of Covid-19.
The US Food and Drug Administration (FDA) has authorised additional doses of Pfizer-BioNTech and Moderna Covid-19 vaccines for certain people with compromised immune systems.
The US Food and Drug Administration (FDA) has declined to approve AstraZeneca and FibroGen’s new drug application (NDA) for roxadustat to treat anaemia associated with chronic kidney disease (CKD).
The US Food and Drug Administration (FDA) has granted priority review for Merck’s supplemental biologics license application (sBLA) for KEYTRUDA (pembrolizumab) as adjuvant therapy for certain patients with renal cell carcinoma (RCC).
The US Food and Drug Administration (FDA) has extended the Emergency Use Authorization (EUA) for Regeneron Pharmaceuticals’ investigational Covid-19 antibody cocktail REGEN-COV.
The US Food and Drug Administration (FDA) has extended the Emergency Use Authorization (EUA) for Eli Lilly and Company and Incyte's baricitinib to treat Covid-19 patients with or without remdesivir.
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.
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