Regulation

Pfizer-BioNTech submit phase 1 data to USFDA for Covid-19 vaccine booster authorisation

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 begins rolling submission for molnupiravir to treat Covid-19 patients in Canada

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.

USFDA authorises additional Covid-19 vaccine doses for people with weak immune systems

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.

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.