Innoviva Specialty Therapeutics has received approval from the US Food and Drug Administration (FDA) for XACDURO to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
The US Food and Drug Administration (FDA) has finished a filing review of Valneva’s Biologics License Application (BLA) for single-shot chikungunya vaccine candidate VLA1553.
Daiichi Sankyo has submitted an application to the regulatory authorities in Japan seeking marketing approval of DS-5670.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has given approval to Beyfortus (nirsevimab) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season.
Bavarian Nordic has signed a supply agreement with the Pan American Health Organization (PAHO) for its monkeypox vaccine.
Bharat Biotech International Limited (BBIL) has announced that its whole-virion inactivated COVID-19 vaccine, BBV152 (COVAXIN), has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials.
Intravacc has signed an exclusive licensing agreement with Beijing Zhifei Lvzhu Biopharmaceutical (Zhifei Lvzhu) in China for Avacc 3, an OMV-based whooping cough vaccine.
BenevolentAI and Drugs for Neglected Disease initiative (DNDi) have commenced a joint AI research project to address dengue.
Merck (MSD outside Canada and the US) has signed an agreement with Thermo Fisher Scientific to manufacture molnupiravir, an investigational oral antiviral medicine to treat Covid-19.
The European Medicines Agency (EMA) has begun a rolling review of Valneva’s VLA2001, a whole-virus inactivated, adjuvanted Covid-19 vaccine candidate.
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