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Hes Back: Makary Rehires Prasad as CBER Head

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Vinay Prasad returns as CBER head at FDA commissioner Marty Makarys request after gaining White House approval.

Novartis to Seek Approval for Sjgrens Disease Drug

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Novartis says that it will seek FDA approval of its investigational drug ianalumab after it met the primary endpoint in two Phase ...

GSK sNDA for Oral Gonorrhoea Treatmemt

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FDA accepts for priority review a GSK supplemental NDA for gepotidacin as an oral treatment for uncomplicated urogenital gonorrhoe...

IO Biotechs Cancer Vaccine Misses Trial Significance

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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.