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).
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.
The European Commission (EC) has granted conditional marketing authorization (CMA) for Novavax’s Covid-19 vaccine Nuvaxovid.
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).
The European Commission (EC) has approved Pfizer’s Cibinqo (abrocitinib) to treat moderate-to-severe atopic dermatitis (AD) adult patients.
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 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).
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