Approvals

EMA’s CHMP recommends approval for AstraZeneca’s Saphnelo to treat SLE

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for AstraZeneca’s Saphnelo (anifrolumab) in the European Union (EU) to treat adult patients with systemic lupus erythematosus (SLE).

Pfizer’s Cibinqo receives EC approval for atopic dermatitis treatment

The European Commission (EC) has approved Pfizer’s Cibinqo (abrocitinib) to treat moderate-to-severe atopic dermatitis (AD) adult patients.

EMA accepts to review Sanofi’s application for ASMD therapy

The European Medicines Agency (EMA) has accepted to review Sanofi’s marketing authorization application (MAA) for olipudase alfa to treat acid sphingomyelinase deficiency (ASMD).

Merck’s Keytruda obtains FDA approval as adjuvant therapy for melanoma patients

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.

CHMP recommends use of Pfizer-BioNTech’s Covid-19 vaccine in children

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 approves Johnson & Johnson’s single-dose Covid-19 vaccine

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 seeks EUA for Covid-19 antiviral pill in US

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 approves Moderna’s Covid-19 vaccine booster shot

Health Canada has authorised the booster shot of Moderna’s Covid-19 vaccine, Spikevax, for individuals aged 18 years and above.

EC approves Roche’s Ronapreve for Covid-19 treatment

The European Commission (EC) has granted marketing authorisation for Roche’s Ronapreve to treat non-hospitalised Covid-19 patients aged 12 years and above.