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Endpoints News3 months ago
FDA gives Denali accelerated approval for rare disease drug
The FDA granted accelerated approval to Denali Therapeutics’ rare disease drug Avlayah, bucking a recent trend of rejections in the space that has put the agency...
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Biotech Industry Intelligence3 months ago
Maze Loses Nearly a Third of Market Share on Mixed Midstage Kidney Drug Data
Maze Loses Nearly a Third of Market Share on Mixed Midstage Kidney Drug Data
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STAT News – Biotech3 months agoCalifornia considers seal of approval for foods that are not ultra-processed
A new California bill continues the state’s efforts to crack down on ultra-processed foods, proposing a front-of-package seal that manufacturers could place on their products to...
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Endpoints News3 months ago
More changes ahead for Takeda with new CEO set to take reins
Takeda’s multi-year restructuring will continue under incoming CEO Julie Kim. The company announced Wednesday that the board has approved “next steps” in its transformation that will...
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STAT News – Biotech3 months agoSTAT+: Bhattacharya addresses CDC director role, works to bolster staff morale in first all-hands meeting
Centers for Disease Control and Prevention staff gathered Wednesday for what many hoped would be an announcement of the Trump administration’s choice for a new leader...
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Endpoints News3 months ago
How Seaport is hedging against failure in Phase 2b depression study
Seaport Therapeutics is building a fail-safe into its Phase 2b depression trial. The biotech is testing its drug, called SPT-300, in patients with major depressive disorder....
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STAT News – Biotech3 months agoHeart failure is common. A quick MRI could improve diagnosis and guide treatment
Hearts need oxygen. Heart attacks are the most dramatic example of this hunger, when blocked coronary arteries starve muscles of the oxygen they need to keep...
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BioPharma Dive – AI / Data3 months agoBeam posts positive data on base editing treatment for AATD
Updated data showed the biotech’s approach to the rare lung and liver condition helped restore functional protective proteins in a small study.
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Endpoints News3 months ago
FDA approves Corcept’s Lifyorli for ovarian cancer months early
The FDA approved Corcept Therapeutics’ Lifyorli in combination with nab-paclitaxel for the treatment of three different kinds of cancer in patients who have received up to...
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AI & Machine Learning in Biotechnology3 months agoSTAT+: FDA approves Denali Therapeutics drug for Hunter syndrome
The Food and Drug Administration on Wednesday approved a new medicine from Denali Therapeutics for a condition called Hunter syndrome, a notable decision by the agency...
STAT+: At hospital finance conference, a call to end the friction that’s keeping costs high
Beyond sunshine: Iberia’s biotech moment has arrived with developing capital networks
