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FDA accepts BridgeBio's filing for rare genetic disease drug

BridgeBio Pharma BBIO announced that the FDA has accepted its regulatory filing seeking approval for the investigational oral ...

Eli Lilly delays retatrutide weight loss drug filing to 2027

Eli Lilly said Thursday it plans to file for regulatory approval of its next-generation weight loss drug retatrutide in the ...
Asianet Newsable on MSN

Eli Lilly moves closer to another weight-loss drug: Retatrutide clears two more phase 3 trials ahead of FDA filing

Retatrutide, a once-weekly triple hormone receptor agonist targeting GIP, GLP-1, and glucagon receptors, met the primary ...

FDA Accepts AstraZeneca's Filing for Expanded Use of Ultomiris

AZN's Ultomiris wins FDA priority review for IgAN, backed by late-stage data showing a 43.4% proteinuria reduction versus placebo.
RAPS

When Can FDA 'Refuse to File' NDAs and BLAs? New Draft Guidance Explains

When a new drug application (NDA) or biologics license application (BLA) is deemed incomplete by the US Food and Drug Administration (FDA), the agency can decide not to review the application. So when ...
Nasdaq

FDA Accepts Sanofi's Filing for Multiple Sclerosis Drug Tolebrutinib (Revised)

Sanofi SNY announced that the FDA has accepted its regulatory filing seeking approval for its investigational BTK inhibitor tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis ...