Regulation

US FDA approves Pfizer-BioNTech’s Covid-19 vaccine

The US Food and Drug Administration (FDA) has fully approved Pfizer and BioNTech’s biologics license application (BLA) for their Covid-19 vaccine, Comirnaty, for individuals aged 16 years and above.

India approves EUA for Zydus Cadila’s ZyCoV-D Covid-19 vaccine

The Drugs Controller General of India (DCGI) has granted emergency use authorisation (EUA) for Zydus Cadila’s ZyCoV-D Covid-19 vaccine for adolescents aged 12 years and above.

EC approves Bristol Myers’ anti-BCMA CAR T-cell treatment for multiple myeloma

The European Commission (EC) has given conditional marketing authorization (CMA) to Bristol Myers Squibb’s (BMS) CAR T-cell therapy Abecma (idecabtagene vicleucel; ide-cel).

US FDA approves Boehringer, Eli Lilly’s Jardiance to treat HFrEF

The US Food and Drug Administration (FDA) has approved Boehringer Ingelheim and Eli Lilly and Company’s Jardiance (empagliflozin) to treat Heart Failure with reduced Ejection Fraction (HFrEF).

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).