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IO Biotechs Cancer Vaccine Misses Trial Significance

[ Price : $8.95]

IO Biotech says its investigational cancer vaccine Cylembio (imsapepimut and etimupepimut, adjuvanted), combined with Mercks Keytr...

Nyxoahs Genio Device OKd for Sleep Apnea

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FDA approves Nyxoahs Genio system, a hypoglossal nerve stimulation therapy for certain patients with moderate to severe obstructiv...

FDA Hits Dr. Reddys Plant with 7-Item 483

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FDA investigators cite seven GMP deficiencies from an inspection conducted last month at a Dr. Reddys drug manufacturing plant in ...

NDA Filed for PROTAC Therapy in Breast Cancer

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FDA accepts for review an Arvinas and Pfizer NDA for vepdegestrant, a first-in-class oral PROteolysis TArgeting Chimera therapy fo...

FDA OKs PharmaThers Ketamine for Surgical Pain

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FDA approves PharmaThers KETARx (ketamine), indicated for use in treating surgical pain.

FDA Orders Stricter Safety Labeling for Skysona

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FDA orders significant labeling changes for Bluebird Bios Skysona (elivaldogene autotemcel), a gene therapy approved for treating ...

Sodium Chloride Drug Shortage Resolved: Makary

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FDA says a nationwide shortage of sodium chloride 0.9% injection products has officially ended.

BD Recalls BD Alaris Pump Software

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Becton Dickinson recalls (Class 1 device correction) its BD Alaris Pump Module Model 8100 with Guardrails, Suite MX software versi...

Accelerated OK for Boehringer Lung Cancer Drug

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FDA grants Boehringer Ingelheim accelerated approval for Hernexeos (zongertinib), a kinase inhibitor for treating certain adults w...

FDA Ramps Up Global Drug Quality Oversight

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FDA expands its drug quality enforcement efforts since the end of the Covid-19 Public Health Emergency, with foreign oversight rea...