Merck, called as MSD outside the US and Canada, has signed voluntary licensing agreements with five Indian generic drug makers to expand access to Molnupiravir, an experimental oral antiviral Covid-19 therapy.
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).
Johnson & Johnson (J&J) will resume Covid-19 vaccine roll-out in Europe following the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC), which confirmed the overall benefit-risk profile being positive.
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.
Integrated pharmaceutical company Dr. Reddy’s Laboratories has secured Emergency Use Authorisation (EUA) from the Drug Controller General of India (DCGI) to import Russia’s Sputnik V vaccine into India.
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).
The US Food and Drug Administration (FDA) has extended the review period for AbbVie’s supplemental New Drug Application (sNDA) for Rinvoq (upadacitinib).
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