Merck grabs FDA green light for less-frequent Keytruda dosing regimen

Κάντε like στη σελίδα μας στο facebook για να μαθαίνετε πρώτοι όλα τα νέα!!   That didn’t take long. Just days after resubmitting its application to the FDA, Merck has nabbed an approval for a new dosing regimen of its immuno-oncology blockbuster, Keytruda. The FDA green-lighted the label update Tuesday, clearing the product for use in 400mg … Συνεχίστε να διαβάζετε Merck grabs FDA green light for less-frequent Keytruda dosing regimen.

Roche SMA therapy granted speedy FDA review; decision by May 2020

Κάντε like στη σελίδα μας στο facebook για να μαθαίνετε πρώτοι όλα τα νέα!!  Dive Brief: The Food and Drug Administration will give Roche's experimental therapy for spinal muscular atrophy a speedy review and will decide on approval within six months, the Swiss pharma​ said Monday. If approved, Roche's risdiplam would be the third SMA therapy … Συνεχίστε να διαβάζετε Roche SMA therapy granted speedy FDA review; decision by May 2020.