News FDA tightens heart tox warnings on mRNA COVID vaccines The FDA has instructed Pfizer and Moderna to add stronger warnings to the labels of their COVID-19 vaccines about the risk of cardiotoxicity.
News Mixed outcomes for pharma in big week for FDA adcomms There was good news for Johnson & Johnson at this week's ODAC meetings, but not for Roche, UroGen, and Pfizer.
News US imposes limits on COVID-19 boosters and new jabs The FDA has introduced a stricter set of policies around COVID-19 vaccines, including requiring clinical trials for new shots in some cases.
News O'Shaughnessy says UK clinical trials sector is on the mend After losing ground in commercial clinical trials in recent years, the UK has now turned a corner and is once again taking a "global lead."
News Call goes out for feedback on US health deregulation The Trump administration wants the public to join in the effort to cull redundant health regulations as part of its '10-for-one' deregulation policy.
News Vinay Prasad will replace Marks as CBER director COVID-19 vaccine mandate critic Vinay Prasad has been named as director of the FDA's Center for Biologics Evaluation and Research (CBER).
News EU clears AZ's SERD camizestrant, as FDA review drags on AstraZeneca's new breast cancer therapy Etcamah claims landmark frontline approval in the EU, but its prospects in the US are less certain.
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