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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

Patients

Action by FDA ensures trial sponsors must consider diversity

Pharma has recognised that there is a problem with diversity in clinical trials, but has so far struggled to successfully achieve real change.

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CDER director Patrizia Cavazzoni and CBER director Peter Marks

FDA launches innovation hub to spur rare disease R&D

The FDA has said it will create a rare disease innovation hub to help speed the development of new treatments and build connections between developers and the rare disease community.

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

Action by FDA ensures trial sponsors must consider diversity

FDA launches innovation hub to spur rare disease R&D

CDC panel votes to scrap hepatitis B birth dose advice

How to meet your physicians where they are online

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