The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that offer significant advances over available options by demonstrating safety or efficacy improvements, preventing serious
The FDA is expected to make a decision in April 2021. The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for abrocitinib in the
This randomized, placebo-controlled, ascending dose study has been designed to assess the safety, tolerability, and pharmacokinetics (PK) of HFB30132A in 24 healthy volunteers. A total of three cohorts
The Food and Drug Administration (FDA) today authorised the restart in the US, following the resumption of trials in other countries in recent weeks. The FDA reviewed all
The orphan drug status to iptacopan has been granted by the regulator after a recommendation from the Committee for Orphan Medicinal Products (COMP). Although considered to be a
This round of funding was co-led by existing investor Rotating Boulder Fund, new investor Walvax Biotechnology Co., Ltd. and Sunshine Riverhead Capital, with support from existing investors Sangel
Veklury is now the first treatment to have been approved by the FDA for Covid-19. It has been approved to be used in adult as well as paediatric
These data presented at IDWeek 2020 show that switching from a standard regimen of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent to Biktarvy is an
While up to 30% of all patients with NSCLC may be diagnosed early enough to have potentially curative surgery, disease recurrence is still common in early-stage disease and
ROR1 is a cell-surface protein that is expressed during embryofetal development but disappears before birth and is usually not expressed on normal cells in children or adults. However,
Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.