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U.S. FDA

U-turn pivot about-face
Pharma

Atara, Pierre Fabre receive 2nd US rejection for Ebvallo

Atara didn't hold back in criticizing the FDA's rationale, noting that the regulator’s new point of view runs “contrary to the FDA’s prior guidance."
Fraiser Kansteiner Jan 12, 2026 11:30am
2026 year ahead look ahead preview forecast new year

3 biopharma CEOs explain why they are 'authentically optimistic'

Jan 6, 2026 11:54am
Monjuvi

Incyte to seek FDA approval for Monjuvi in front-line DLBCL

Jan 5, 2026 10:40am
game over pivot new direction

InflaRx may find path forward for COVID drug in skin disorder

Jan 2, 2026 10:25am
Novo Nordisk

Novo snags FDA nod for oral obesity med with Wegovy in a pill

Dec 22, 2025 6:59pm
drugs 2025 2025 in pharma regulatory tracker pharma 2025

Regulatory tracker: Rubraca scores full prostate cancer approval

Dec 18, 2025 2:45pm

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