Immuno-dermatology specialist intends to submit the topical roflumilast to the US FDA during the first half of 2023, potentially adding an even larger indication to its approval for psoriasis.
With success in a second Phase III trial of its topical formulation of roflumilast in atopic dermatitis, Arcutis Biotherapeutics, Inc. moved closer to seeking a supplemental approval of Zoryve (roflumilast) in AD, which analysts said would be an even bigger market opportunity than the drug’s initial indication in plaque psoriasis.
Arcutis obtained US Food and Drug Administration approval of the topical phosphodiesterase-4 (PDE4) inhibitor for plaque psoriasis in July and...
Seeking to move Columvi into second-line DLBCL, Genentech got an FDA letter saying the Phase III STARGLO study’s benefits may have been driven by results in Asian enrollees.
The drugmaker announced topline results from the Phase III INDEPENDENCE trial, which did meet key secondary endpoints.
As AI-driven firms like Insilico, big pharma like J&J, Amgen, GSK and AstraZeneca and Chinese and Indian firms like BeOne and Dr. Reddy’s respectively advance PRMT5 inhibitor candidates, what’s driving interest, what could lead to the first global approval and what are the challenges ahead?
After presenting encouraging Phase II data on the GSK-3 inhibitor elraglusib at ASCO, Actuate Therapeutics is hoping to hold a pre-NDA meeting with the US FDA.
After presenting encouraging Phase II data on the GSK-3 inhibitor elraglusib at ASCO, Actuate Therapeutics is hoping to hold a pre-NDA meeting with the US FDA.
The go-ahead to resume a trial for its only drug candidate, zetomipzomib, in hepatitis could give Kezar a glimmer of hope of reviving another halted study in lupus nephritis.
Anselamimab was expected to complement Alexion's portfolio of amyloid therapies, but regulators will have to be convinced of its benefits to a patient subgroup in the CARES trial.
