News FDA ends emergency COVID authorisations, issues narrow appro... RFK has declared the end of the COVID-19 emergency as the FDA issued approvals for the 2025 COVID shots in elderly and compromised patients only.
News Court sides with Vanda over FDA's Hetlioz rejection A court has ordered the FDA to revisit a decision to turn down a drug for jet lag developed by Vanda, potentially setting a crucial legal precedent.
News Leaked MAHA draft signposts US health reform under Trump A leaked version of the Make America Healthy Again programme for the Trump administration has plenty for the pharma industry to stew over.
News FDA clears Precigen's rare tumour immunotherapy Precigen has won approval in the US for a first-in-class immunotherapy for recurrent respiratory papillomatosis, Papzimeos, its first product.
News FDA restricts use of bluebird's Skysona gene therapy The FDA has added a warning label to bluebird bio's Skysona, after launching a probe into cases of blood cancer linked to the gene therapy.
News Vinay Prasad returns to FDA In a new spin on the concept of the FDA's 'revolving door', Vinay Prasad is back as head of CBER, just over a week after leaving the role.
News Repligen builds in cell therapy with $1.5bn BioLife takeover Repligen has reached a deal to buy cell therapy specialist BioLife Solutions for $1.5bn, tapping into a market growing at breakneck speed.
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