FDA issues complete response letter for Merck’s chronic cough treatment
The regulatory agency sought further data linked to the measurement of efficacy.
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FDA limits usage of Lilly and Regeneron’s monoclonal antibodies for Covid-19
The move comes after data showed these therapies are highly unlikely to be active against the Omicron variant.
FDA expands approval for AbbVie’s Skyrizi for active psoriatic arthritis
The FDA approval is based on data from two Skyrizi Phase III trials, KEEPsAKE-1 and KEEPsAKE-2.
FDA issues complete response letter to BLA for Pfizer-OPKO’s somatrogon
Somatrogon is a long-acting recombinant human growth hormone administered once weekly.
Gilead’s Veklury obtains FDA approval to treat Covid-19 outpatients
The authorised dosage is daily intravenous doses of Veklury to be administered for three consecutive days.
Bristol-Myers Squibb’s Abecma gets approval in Japan for multiple myeloma
The approval for Abecma is based on data obtained from the Phase II Study BB2121-MM-001 and the Phase I Study…
US FDA clears Nuvation Bio’s application for solid tumour therapy
The company will start a trial of NUV-868 as a single agent and along with olaparib or enzalutamide in solid…
Japan approves Pfizer-BioNTech’s Covid-19 vaccine for children
The vaccine doses that will be administered for children will use one-third of a dose given for adults.