The US Food and Drug Administration (FDA) has expanded the emergency use authorisation (EUA) for Pfizer and BioNTech’s Covid-19 vaccine to include adolescents aged 12 to 15 years.
The Russian Direct Investment Fund (RDIF) has announced that a single dose Covid-19 vaccine called Sputnik Light, obtained authorisation for use in the country.
ViiV Healthcare has initiated a rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for long-acting cabotegravir to prevent human immunodeficiency virus (HIV).
World Health Organization (WHO) has granted emergency use listing (EUL) for Moderna's Covid-19 vaccine to prevent the infection in people aged 18 years and above.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended conditional marketing authorisation for AstraZeneca and Merck’s selumetinib to treat paediatric patients aged three years and older with neurofibromatosis type 1 (NF1), symptomatic and inoperable plexiform neurofibromas (PN).
The US Federal trade Commission review has granted clearance for AstraZeneca’s proposed acquisition of Alexion Pharmaceuticals, achieving an important milestone in the completion process.
GlaxoSmithKline and Vir Biotechnology have announced the European Medicines Agency (EMA) review of VIR-7831 (GSK4182136) for the early treatment of Covid-19.
Gilead Sciences has announced the accelerated approval of Trodelvy (or sacituzumab govitecan-hziy) by the US Food and Drug Administration (FDA) in the treatment of locally advanced or metastatic urothelial cancer (UC) in adult patients.
AbbVie has submitted applications seeking approval for SKYRIZI (risankizumab-rzaa, 150 mg) and SKYRIZI (risankizumab, 150 mg) to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively, for the treatment of adults with active psoriatic arthritis.
The US Food and Drug Administration (FDA) has extended the review period for Eli Lilly and Incyte’s supplemental New Drug Application (sNDA) for OLUMIANT (baricitinib).
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