Clinical Trials
Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years
Pfizer Inc. and BioNTech SE announced results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children...
Drug Research
FDA Approves Samsung Bioepis and Biogens BYOOVIZ, LUCENTIS Biosimilar
Samsung Bioepis Co., Ltd. and Biogen Inc. announced that the U.S. FDA has approved BYOOVIZ (ranibizumab-nuna), a biosimilar referencing LUCENTIS® (ranibizumab)i , for the...
Press Releases
Celltrion’s regdanvimab becomes the first authorized COVID-19 treatment approved from the Korean MFDS
Celltrion Group announced that the Korean Ministry of Food and Drug Safety (MFDS) approved regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19 for the...
Clinical Trials
Valneva Completes Recruitment of Elderly Participants in Phase 3 Trial of its Inactivated COVID-19 Vaccine
Valneva SE, a specialty vaccine company, announced that it has completed recruitment of the initial cohort of elderly participants in Valneva’s Phase 3 trial,...
Clinical Trials
RedHill Biopharma Reports Top-Line Data from Opaganib Phase 2/3 Study in Severe COVID-19 Patients
RedHill Biopharma Ltd. , a specialty biopharmaceutical company, announced preliminary top-line data from the 475-patient global Phase 2/3 study with opaganib (ABC294640) in hospitalized...
News
Glenmark completes PMS study of Covid-19 drug Favipiravir
Glenmark Pharmaceuticals, a research-led, global integrated pharmaceutical company, announced the successful completion of its Post Marketing Surveillance (PMS) study on Favipiravir (FabiFlu®) in India....
News
EUA for Lilly’s bamlanivimab and etesevimab administered together expanded to include post-exposure prophylaxis for COVID-19
The U.S. FDAhas expanded the Emergency Use Authorization (EUA) for bamlanivimab 700 mg and etesevimab 1400 mg administered together to include post-exposure prophylaxis (PEP)...
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