FDA advisory committee recommends Pfizer Covid-19 vaccine for kids five to 11 years
The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviewed the data, and voted 17 to 0,…
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27 Oct 21
The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviewed the data, and voted 17 to 0,…
25 Oct 21
Susvimo, earlier known as Port Delivery System with ranibizumab, is said to be the first and only FDA-approved…
22 Oct 21
The EC approval was based on results from the Phase 3 CheckMate-649 trial, which showed positive outcomes for…
21 Oct 21
The US FDA has also authorised the use of heterologous booster dose of Covid-19 vaccines, in addition to…
20 Oct 21
Zuranolone is an oral, once-daily, two-week therapy intended to treat major depressive disorder (MDD) and postpartum depression (PPD)
20 Oct 21
Lenalidomide is a generic version of Celgene’s Revlimid, intended to treat multiple myeloma (MM), myelodysplastic syndromes (MDS), and…
19 Oct 21
Biktarvy is a once-daily dosing complete HIV-1 treatment comprising three medicines, with a limited drug interaction potential and…
19 Oct 21
The regulatory submission is based on data from the Phase 2/3 study of the Comirnaty 10μg dose in…
18 Oct 21
The FDA approval is based on the Phase 3 IMpower010 study, which showed that adjuvant Tecentriq improved disease-free…
18 Oct 21
The recommendation is based on results from two clinical trials, including the Phase 3 ENSEMBLE 2 study, and…