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WHO recommends groundbreaking malaria vaccine for children
The World Health Organization (WHO) recommends GSK's RTS,S/AS01 (RTS,S) malaria vaccine for use in children in sub-Saharan Africa.
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Regs & Legs
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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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New FDA draft guidance on microbiological quality of NSDs
The draft guidance discusses product development considerations, risk assessments and cGMPs relevant to microbiological control in non-sterile drug (NSD) manufacturing.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, September 2021
The EMA’s drug safety committee (PRAC) assessed risks of thrombocytopenia and venous thromboembolism with the Janssen COVID-19 Vaccine.
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NICE recommends first sickle cell disease treatment in 20 years
Crizanlizumab recommended as a treatment option for preventing recurrent sickle cell crises for people aged 16 and over in the UK.
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New EFPIA network created to combat cardiovascular diseases
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has initiated the CVD Network to improve policies for patients.
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EMA evaluate booster dose of COVID-19 vaccine Spikevax
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.
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FDA authorises Comirnaty® booster dose for certain populations
The US FDA amended the emergency use authorisation to allow for a Comirnaty booster dose in individuals at high-risk for COVID-19.
whitepaper
Whitepaper: Best practices in environmental monitoring
This whitepaper outlines the important components of an environmental monitoring programme, providing practical advice and best practice guidance.
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EMA’s human medicines committee (CHMP) September meeting highlights
In its most recent meeting, the CHMP recommended nine new medicines and concluded its review of Vaxzevria’s thrombosis risk.
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Mobocertinib approved as first oral therapy for EGFR Exon20+ NSCLC
FDA approves mobocertinib as the first oral therapy for patients with non-small cell lung cancer with EGFR Exon20 insertion mutations.
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Immuno-bridging studies are sufficient for authorising new COVID-19 vaccines, say regulators
The Access Consortium, comprising regulators from the UK, Australia, Canada, Singapore and Switzerland, announce that immuno-bridging studies can be used to support COVID-19 vaccine authorisation.
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Novartis submit BLA for tislelizumab for oesophageal cancer treatment
US FDA have accepted Biologics License Application (BLA) for tislelizumab for the treatment of oesophageal squamous cell carcinoma cancer.
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MHRA approve Pfizer and AstraZeneca COVID-19 vaccine booster doses
The UK regulator confirmed that the Pfizer and AstraZeneca COVID-19 vaccines can be used as safe and effective booster doses.
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NICE recommends tofacitinib for juvenile idiopathic arthritis
NICE has recommended Pfizer’s Xeljanz® (tofacitinib) as an option to treat polyarticular juvenile arthritis and juvenile psoriatic arthritis.
