regulatory

News

Wockhardt has completed a pre-filing meeting with the FDA and is preparing to submit its novel antibiotic Zaynich in the US and Europe.

News

With new guidance, the EMA is seeking to ramp up the inclusion of pregnant and breastfeeding women in clinical trials.

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The FDA has rolled out its highly-touted generative AI tool, almost a month early, with a promise to reduce the time taken for regulatory reviews.

News

Stealth BioTherapeutics' filing for Barth syndrome therapy elamipretide has been turned down by the FDA, but there may be a way forward for the drug.

News

MSD and Daiichi Sankyo suffer another setback with their HER3 programme ahead of a crucial data readout at ASCO.

News

Teva gets fast-track status from the FDA for a coeliac disease drug with a mechanism that has proved tough to crack.