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Sunday 24 May 2026

FDA

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Motif pummelled as FDA asks for more data on antibiotic

Motif pummelled as FDA asks for more data on antibiotic

Shares in UK biotech Motif Bio fell more than 50% after its much-delayed antibiotic was held up at the FDA once again by a request for another clinical trial.

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FDA rejects Heron's non-opioid painkiller

FDA rejects Heron's non-opioid painkiller

Shares in US biotech Heron Therapeutics were sharply down yesterday after the FDA rejected its post-operative painkiller, saying additional manufacturing and non-clinical information is nee

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Colony of pathogen bacteria - 3d render

FDA rejects Nabriva's antibiotic over manufacturing concerns

The FDA has rejected a proposed antibiotic from the Irish biotech Nabriva Therapeutics, citing concerns about manufacturing standards.

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FDA approves first treatment for children with lupus

FDA approves first treatment for children with lupus

The US FDA has approved GSK’s Benlysta (belimumab) intravenous infusion for the treatment of children with lupus.

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FDA approves first medical device ADHD treatment

FDA approves first medical device ADHD treatment

US regulators have given the green-light for the first medical device to treat attention deficit hyperactivity disorder (ADHD).

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childhood epilepsy awareness

Zogenix slumps after FDA refuses epilepsy drug file

Zogenix’s only drug candidate is facing a long delay after the FDA refused to accept its marketing application, asking for toxicology data.