USA – Study: Blockbuster, accelerated approval drugs more likely to get new FDA-approved formulation
Drugs with blockbuster status and those approved under the US Food and Drug Administration’s (FDA’s) accelerated approval pathway were more likely to receive a...
Europe – Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended...
EMA’s human medicines committee (CHMP) has recommended authorising an adapted bivalent vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the original...
UK – NICE recommends Pfizer’s Paxlovid on NHS
Pfizer has announced today that the National Institute for Health and Care Excellence (NICE) has issued an appraisal consultation document which recommends Paxlovid.
Also known...
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...
Europe – EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17
EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid to include use in adolescents aged 12 to 17...
USA – FDA works to advance real-world data collection in pregnancy and lactation
The US Food and Drug Administration (FDA) is working on ways to facilitate greater use of real-world data (RWD) to help understand the safety...
USA – Guidance: FDA details ANDA PSG meetings under GDUFA III
The US Food and Drug Administration (FDA) last week issued draft guidance that details its thinking on conducting product-specific guidance (PSG) meetings with generic...
