Canada Becomes First Country to Authorize Pfizer Vaccine for Adolescents
Canada has become the first country in the world to authorize the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents
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Regulatory
The 2021 ABPI Code for the British Pharmaceutical Industry is Released
The Code of Practice of the Association of the British Pharmaceutical Industry (ABPI) lays down the rules that the industry
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Shorla Pharma Files FDA Priority Review for T-cell Leukemia Treatment
Irish pharmaceutical company Shorla Pharma Limited (‘Shorla’), has reported that it has successfully filed a priority review application for its
Read moreEC Approves Second Indication of Sarclisa® for Relapsed Multiple Myeloma
The European Commission (EC) has approved Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone (Kd) for the treatment of adult
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EMA Reviews GSK and Vir’s Monoclonal Antibody for COVID-19 Treatment
GSK and Vir Biotechnology have announced that the EMA has started a review of the dual-action monoclonal Antibody VIR-7831 for
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EU Authorizes Teva’s Seffalair® Spiromax® and BroPair® Spiromax®
Teva Pharmaceuticals Europe reported that Seffalair Spiromax and its duplicate BroPair Spiromax (salmeterol xinafoate/fluticasone propionate, 12.75/100 and 12.75/202 micrograms administered
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EU and U.K. Seek to Ease Tensions over COVID-19 Vaccine Supplies
The European Union and the United Kingdom have said they are working together on steps to improve their relationship, following
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Johnson & Johnson’s single-shot vaccine approved by EU regulator
The European Commission (EC) approval of Johnson & Johnson’s vaccine has paved the way for EU nations to use the
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FDA issues new guidance for Pfizer/BioNTech COVID-19 vaccine storage
The U.S. Food and Drug Administration has revisited data on the stability of the Pfizer/BioNTech COVID-19 doses at normal pharmaceutical
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J&J’s COVID-19 single-shot jab approved by the FDA for Emergency Use
The U.S. FDA has approved the first single-shot COVID-19 jab, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson,
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