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PBC drug choices rise in US with OK for Gilead's seladelpar

At the start of the year, there had been no new therapies for rare cholestatic liver disease primary biliary cholangitis (PBC) in the US for almost a decade.

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Article retractions muddy MDMA waters after FDA denial

The journal Psychopharmacology has retracted three articles about MDMA-assisted psychotherapy, shortly after the FDA rejected approval of Lykos Therapeutics' therapy for post-traumatic stre

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FDA clears first anaphylaxis nasal spray at second attempt

ARS Pharma has claimed FDA approval for its epinephrine nasal spray neffy, becoming the first needle-free alternative to EpiPen-style autoinjectors for serious allergic reactions.

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FDA shoots down Lykos' MDMA therapy for PTSD

The FDA has denied Lykos Therapeutics' marketing application for its post-traumatic stress disorder (PTSD) therapy based on MDMA, also known as ecstasy, in a setback for the emerging psyche

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Actinium's radioligand filing plans scuppered by FDA

Shares in Actinium Pharmaceuticals have lost almost two-thirds of their value after the FDA asked for a second clinical trial before it would consider reviewing the company's Iomab-B radiol

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ODAC unpicks AZ's Imfinzi trial in perioperative NSCLC

FDA reviewers were so frustrated by AstraZeneca's application for Imfinzi as a treatment before and after surgery for resectable non-small cell lung cancer (NSCLC) that they voted for a ret

PBC drug choices rise in US with OK for Gilead's seladelpar

Article retractions muddy MDMA waters after FDA denial

FDA clears first anaphylaxis nasal spray at second attempt

FDA shoots down Lykos' MDMA therapy for PTSD

Actinium's radioligand filing plans scuppered by FDA

ODAC unpicks AZ's Imfinzi trial in perioperative NSCLC

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