USA – FDA issues 80 guidances for topical products
The FDA has issued eight new product-specific draft guidances and 72 revised draft guidances for sponsors of topical products applied to the skin or...
USA – OIG raises concerns about accelerated approval pathway
More than one-third of accelerated approval applications do not meet their original confirmatory trial dates, and four drug applications were more than 5 years...
USA – House report finds Trump officials sought to influence FDA during COVID pandemic
Officials in the Trump administration pressured the US Food and Drug Administration (FDA) during the first year of the COVID-19 pandemic to make regulatory...
UK – NICE recommends Rhythm Pharmaceuticals’ Imcivree for severe obesity and hyperphagia
The recommendation follows positive results from clinical trials suggesting that Imcivree may reduce weight and body mass index (BMI) in people with obesity caused...
USA – Top FDA official interested in ‘Project Orbis’ for cell and gene therapies
A top official from the US Food and Drug Administration (FDA) said he wants to see something similar to the agency’s Project Orbis program...
Europe – Regulatory, industry panels address EU GMP Annex 1 implementation
Pharmaceutical manufacturers in the EU may have to approach the manufacturing of sterile drugs a little differently under the EU’s Annex 1 covering good...
UK – Sanofi Pasteur COVID-19 vaccine authorised by MHRA
VidPrevtyn Beta, the COVID-19 vaccine developed by Sanofi, has been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA).
It becomes the seventh COVID-19...
International – mRNA revolutionized the race for a Covid-19 vaccine. Could cancer be next?
The unprecedented success of messenger RNA vaccines against the coronavirus is raising hopes that the technology could lead to new and better vaccines against...
UK – AstraZeneca’s Lynparza recommended by NICE for breast and prostate cancer
The anti-cancer medicine will now be routinely available for adults with HER2-negative, high-risk early breast cancer who have inherited faults in their BRCA1 or...
USA – FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults
Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment...
