EMA approve Comirnaty®and Spikevax booster doses
The EMA concludes that booster doses of the COVID-19 vaccines Comirnaty and Spikevax can be given to people with severely weakened immune systems.
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The EMA concludes that booster doses of the COVID-19 vaccines Comirnaty and Spikevax can be given to people with severely weakened immune systems.
The draft guidance discusses product development considerations, risk assessments and cGMPs relevant to microbiological control in non-sterile drug (NSD) manufacturing.
The EMA’s drug safety committee (PRAC) assessed risks of thrombocytopenia and venous thromboembolism with the Janssen COVID-19 Vaccine.
Late-breaking data highlights the emerging clinical profile of amlitelimab in adults with inadequately controlled atopic dermatitis.
The investigational respiratory syncytial virus (RSV) vaccine candidate demonstrated 80 percent efficacy in adults aged 65 and older.
EPR's Anna Begley reviews some of the latest results for AstraZeneca’s Enhertu (trastuzumab deruxtecan) HER2-directed cancer therapy.
BioNTech expands clinical oncology portfolio with first patient dosed in Phase II trial of mRNA-based vaccine for colorectal cancer.
In a study conducted in children under 12 years old, the ganaplacide/lumefantrine combination significantly reduced malaria infection.
Phase II/III trial shows Ronapreve significantly reduced viral load in seronegative patients hospitalised with COVID-19, complimenting previous findings.
Interim results from the BE BRIGHT study shows that bimekizumab is effective and safe for the treatment of moderate to severe psoriasis.
Dovato demonstrated non-inferior efficacy compared to TAF-based regimens in virologically suppressed adults with HIV-1 in Phase III study.
Valneva and Pfizer’s Lyme disease vaccine VLA15 displayed a seroconversion rate of 100 percent for all OspA serotypes in Phase II study.
Sanofi’s first mRNA COVID-19 vaccine displayed neutralising antibody seroconversion in 91 to 100 percent of participants in a Phase I/II study.
The European Medicines Agency (EMA) is evaluating an application for the use of a booster dose of Spikevax in people aged 12 years and older.
Innovent Biologics and AnHeart Therapeutics jointly announced the interim clinical data from a Phase II trial (TRUST) evaluating taletrectinib (AB-106), an investigational next-generation ROS1/NTRK inhibitor in ROS1-positive non-small cell lung cancer (NSCLC). The data was announced at the Chinese Society of Clinical Oncology (CSCO) 2021. Taletrectinib is an investigational next-generation…