Approvals

Sandoz seeks EMA approval for EirGenix’s trastuzumab biosimilar

Novartis’ subsidiary Sandoz has submitted a marketing authorisation application to the European Medicines Agency (EMA) for the EirGenix-developed proposed trastuzumab biosimilar drug (150 mg).

FDA approves ViiV Healthcare’s Apretude for HIV prevention

ViiV Healthcare has received the US Food and Drug Administration (FDA) approval for Apretude (cabotegravir extended-release injectable suspension) as an injectable pre-exposure prophylaxis (PrEP) option for HIV prevention.

Novavax gets EC marketing authorization for Covid-19 vaccine

The European Commission (EC) has granted conditional marketing authorization (CMA) for Novavax’s Covid-19 vaccine Nuvaxovid.

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.