Infectious Disease
Pfizer and BioNTech seek EUA for Omicron-adapted Covid-19 vaccine in children
Pfizer and BioNTech have filed an application seeking emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for their Omicron…
India’s CDSCO approves Bharat Biotech’s intra-nasal vaccine for Covid-19
India’s Central Drugs Standard Control Organisation (CDSCO) has granted approval for Bharat Biotech’s BBV154 vaccine for treating Covid-19. BBV154 is…
Roche to supply Actemra IV courses to Canada for Covid-19
Hoffmann-La Roche (Roche Canada) has entered an agreement with the Canadian Government to supply Actemra IV (tocilizumab for injection) courses…
US FDA approves Ferring’s Rebyota for Clostridioides difficile infection
The US Food and Drug Administration (FDA) has granted approval for Ferring Pharmaceuticals’ faecal microbiota product, Rebyota, to prevent Clostridioides difficile infection (CDI) recurrence…
UTMB and HDT Bio receive US funding for vaccine development
The University of Texas Medical Branch (UTMB) and HDT Bio have received funding worth up to $87.4m in a project agreement…
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Biovac and IVI enter deal to develop oral cholera vaccine
South African bio-pharmaceutical firm Biovac and the International Vaccine Institute (IVI) in South Korea have signed a licencing and technology…
Japan grants emergency regulatory approval for Shionogi’s Covid-19 drug
The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted emergency regulatory approval for Shionogi’s new anti-SARS-CoV-2 drug, Xocova (ensitrelvir fumaric…
RVAC Medicines, A*STAR partner for mRNA manufacturing expertise
RVAC Medicines has signed a master research partnership agreement with the Agency for Science, Technology and Research (A*STAR) for analysing…
Health Canada grants expanded authorisation for Novavax’s Covid-19 vaccine
Health Canada has granted expanded authorisation for Novavax’s Covid-19 vaccine (Recombinant protein, Adjuvanted) [Nuvaxovid; NVX-CoV2373] as a homologous booster for usage in adults…
EC grants approval for Sanofi-GSK’s Covid-19 booster
The European Commission (EC) has granted approval for Sanofi and GSK’s monovalent, recombinant-protein-based, adjuvanted Covid-19 vaccine, VidPrevtyn Beta, as a booster in adults aged 18…
FDA grants EUA for Sobi’s Covid-19 treatment
The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Swedish Orphan Biovitrum AB’s (Sobi) Kineret (anakinra) to treat…
UK MHRA approves Pfizer-BioNTech’s bivalent Covid-19 booster
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech’s bivalent Covid-19 booster vaccine that targets the SARS-CoV-2…
EC approves AstraZeneca-Sanofi’s Beyfortus for preventing RSV in infants
The European Commission (EC) has granted approval for AstraZeneca and Sanofi’s Beyfortus (nirsevimab) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTI) in…
Health Canada grants authorisation for Moderna’s Omicron-based booster
Health Canada has granted authorisation for Moderna’s BA.4/BA.5 Omicron-targeting bivalent Covid-19 booster vaccine, mRNA-1273.222, for people aged 18 years and above. The 50µg…
WHO grants prequalification for Sinovac’s varicella vaccine
The World Health Organization (WHO) has granted prequalification for Sinovac Biotech’s live attenuated varicella vaccine. With the latest development, the vaccine became…