Regulation

EMA’s CHMP recommends approval for Novo Nordisk’s Wegovy for obesity

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation by the European regulatory authorities for Novo Nordisk’s anti-obesity medication Wegovy.

Boehringer-Lilly’s Jardiance obtains FDA priority review to treat heart failure

Eli Lilly and Company and Boehringer Ingelheim’s Jardiance (empagliflozin) has obtained priority review from the US Food and Drug Administration (FDA) to treat adults with heart failure regardless of left ventricular ejection fraction (LVEF).

NICE recommends AstraZeneca’s dapagliflozin to treat chronic kidney disease

The UK’s National Institute for Health and Care Excellence (NICE) has recommended AstraZeneca’s dapagliflozin as a treatment for people with chronic kidney disease (CKD).

Swissmedic approves EffRx’s Bronchitol to treat cystic fibrosis

EffRx Pharmaceuticals has received marketing authorisation from Swissmedic for Bronchitol to treat cystic fibrosis (CF) in adults and in children aged six years and above.

Novavax seeks emergency use listing from WHO for Covid-19 vaccine

Novavax has completed the rolling submission to the World Health Organization (WHO) for emergency use listing (EUL) of its Covid-19 vaccine candidate, NVX-CoV2373.

FDA provides EUA for Pfizer-BioNTech’s Covid-19 vaccine in children

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for Pfizer-BioNTech’s Covid-19 vaccine for children aged 5 to 11 years.

EC approves Merck’s Keytruda and chemotherapy combination for TNBC patients

The European Commission (EC) has approved Merck’s Keytruda (pembrolizumab) plus chemotherapy combination to treat triple-negative breast cancer (TNBC) patients.

BeiGene’s Brukinsa receives approval to treat mantle cell lymphoma in Russia

The Russia Ministry of Health has approved BeiGene’s Brukinsa (zanubrutinib) to treat patients with relapsed or refractory mantle cell lymphoma (MCL).

US FDA approves Oyster Point Pharma’s nasal spray for dry eye disease

The US Food and Drug Administration (FDA) has approved Oyster Point Pharma’s TYRVAYA (varenicline solution) Nasal Spray for the treatment of dry eye disease signs and symptoms.