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.
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.
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.
The European Commission (EC) has approved Merck’s Keytruda (pembrolizumab) plus chemotherapy combination to treat triple-negative breast cancer (TNBC) patients.
The Russia Ministry of Health has approved BeiGene’s Brukinsa (zanubrutinib) to treat patients with relapsed or refractory mantle cell lymphoma (MCL).
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.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved two additional production sites for making Pfizer-BioNTech’s Covid-19 vaccine, Comirnaty.
The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has unanimously recommended grant of Emergency Use Authorization (EUA) for Johnson & Johnson’s (J&J) Covid-19 vaccine booster shot.
Brii Biosciences has filed an emergency use authorization (EUA) application for its investigational SARS-CoV-2 monoclonal antibody combination therapy, BRII-196/BRII-198, to the US Food and Drug Administration (FDA).
Kite, a subsidiary of Gilead Sciences, has received the US Food and Drug Administration (FDA) approval for its Tecartus (brexucabtagene autoleucel) to treat patients with relapsed or refractory b-cell acute lymphoblastic leukemia (ALL).
The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved AstraZeneca’s Saphnelo (anifrolumab) to treat adult patients with systemic lupus erythematosus (SLE).