Regulation

FDA rejects AstraZeneca-FibroGen’s roxadustat for CKD-related anaemia

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).

USFDA grants priority review to Merck’s sBLA for KEYTRUDA

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).

USFDA authorises REGEN-COV for post-exposure prophylaxis for Covid-19

The US Food and Drug Administration (FDA) has extended the Emergency Use Authorization (EUA) for Regeneron Pharmaceuticals’ investigational Covid-19 antibody cocktail REGEN-COV.

USFDA authorises baricitinib for emergency use as monotherapy for Covid-19 patients

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.

EMA’s CHMP recommends EU approval for Moderna’s Covid-19 vaccine for adolescents

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.

FDA approves Merck, Eisai’s Keytruda and Lenvima combination for endometrial cancer

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 completes acquisition of biopharmaceutical firm Alexion

AstraZeneca has completed the acquisition of biopharmaceutical company Alexion Pharmaceuticals in a deal valued at $39bn.

Japan approves Roche’s Ronapreve for Covid-19 treatment

Roche has received Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for its Ronapreve to treat mild to moderate Covid-19 patients.

US FDA grants priority review to tezepelumab to treat asthma 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.