Merck’s anti-PD-1 therapy, Keytruda, has obtained approval from the US Food and Drug Administration (FDA) as an adjuvant therapy for stage IIB or IIC melanoma patients aged 12 years and above.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the use of Pfizer and BioNTech’s Covid-19 vaccine, Comirnaty, in children aged five to 11 years.
Health Canada has granted full approval to Janssen Pharmaceutical Companies of Johnson & Johnson’s single-dose Covid-19 vaccine for the disease prevention in people aged 18 years and above.
Pfizer has submitted an application to the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) of its investigational oral antiviral drug, Paxlovid (PF-07321332; ritonavir).
Health Canada has authorised the booster shot of Moderna’s Covid-19 vaccine, Spikevax, for individuals aged 18 years and above.
The European Commission (EC) has granted marketing authorisation for Roche’s Ronapreve to treat non-hospitalised Covid-19 patients aged 12 years and above.
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.
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).
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).
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.
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