Approvals

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.

FDA provides EUA for Pfizer-BioNTech’s Covid-19 vaccine in children

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.

EC approves Merck’s Keytruda and chemotherapy combination for TNBC patients

The European Commission (EC) has approved Merck’s Keytruda (pembrolizumab) plus chemotherapy combination to treat triple-negative breast cancer (TNBC) patients.

BeiGene’s Brukinsa receives approval to treat mantle cell lymphoma in Russia

The Russia Ministry of Health has approved BeiGene’s Brukinsa (zanubrutinib) to treat patients with relapsed or refractory mantle cell lymphoma (MCL).

US FDA approves Oyster Point Pharma’s nasal spray for dry eye disease

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.

EMA approves two new sites for making Pfizer-BioNTech’s Covid-19 vaccine

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.

US FDA’s VRBPAC recommends J&J Covid-19 vaccine booster shot

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 files application for EUA for BRII-196/BRII-198 therapy in US

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 gets US FDA approval for Tecartus to treat acute lymphoblastic leukemia

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).