FDA grants EUA for Pfizer-BioNTech’s Covid-19 booster in children
The expanded EUA for use of booster dose in children is based on the findings from a Phase II/III clinical…
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FDA declines to grant EUA for antidepressant to treat Covid-19
The data was inadequate to conclude that the drug was effective in preventing disease progression, FDA noted.
Lilly’s Mounjaro receives FDA approval for type 2 diabetes treatment
The approval is based on findings from the Phase III SURPASS programme of Mounjaro.
EC to terminate Covid-19 vaccine deal with Valneva
The EC can terminate the agreement if the vaccine does not obtain marketing authorisation from EMA by the end of…
Pfizer and BioNTech amend Covid-19 vaccine supply deal with EC
The vaccine doses planned to be supplied between June and August will now be delivered from September to Q4 of…
FDA grants Orphan Drug Designation to Editas’ beta thalassemia therapy
The company intends to commence a Phase I/II trial of EDIT-301 in transfusion-dependent beta thalassemia patients this year.
Taiho signs deal to acquire Cullinan Pearl for up to $405m
On Taiho acquiring Cullinan Pearl, Cullinan Oncology is entitled to receive $275m in upfront payment.
BridgeBio and BMS partner to develop BBP-398 for cancer
Under the deal, BMS will make upfront and milestone payments of up to $905m to BridgeBio.