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FDAers Assess Frontline Renal Cancer Treatments

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CDER and Oncology Center of Excellence researchers say a pooled analysis showed the frontline immune-oncology/tyrosine kinase inhi...

Sun Pharma India Facility on Import Alert

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FDA issues an import alert on drug products manufactured by Sun Pharmaceutical Industries in Gujrat, India due to significant GMP ...

FDA Struggles to Recruit in Wake of Retirements

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FDA chief of staff Julie Tierney says the agency is experiencing a larger-than-normal exodus of retiring employees now that the Co...

Abiomed Recalls Impella Heart Pump

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Abiomed recalls its Impella 5.5 with SmartAssist System after receiving complaints about purge fluid leaking from the devices purg...

FDA on Pneumatic Tourniquet Cuff Shortage

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FDA issues a Dear Doctor letter about supply constraints involving non-sterile, single-use pneumatic tourniquet cuffs in the U.S....

FDA Lifts Hold on Foghorn Leukemia Drug

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FDA removes a partial clinical hold against Foghorn Therapeutics Phase 1 monotherapy dose escalation study of FHD-286 in acute mye...

Draeger Recalls Ventilator Sets/Tubing

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Draeger Medical recalls its ventilator set, tubing and support (with harness) because glued connections on the breathing circuit c...

Intas Pharma on Import Alert After Inspection

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FDA places an import alert on drug products manufactured by Intas Pharmaceuticals in Ahmedabad, Gujarat, India due to significant ...

FDA Extends Review of SpringWorks NDA

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FDA extends by three months its review of a SpringWorks Therapeutics NDA for nirogacestat for treating adults with desmoid tumors.

Guidance on ANDA Cover Letter Attachments

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FDA posts a final guidance entitled Cover Letter Attachments for Controlled Correspondence and ANDA Submissions.