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The company reported revenue of $37.2 million in the first quarter, up 39% year over year, but said it has faced challenges in achieving higher rates of adoption in the past.

Tidmarsh, an adjunct professor at Stanford’s medical school, brings decades of industry experience to the table. Serving as director of the Center for Drug Evaluation and Research will be his first government position.

The biotech is planning to expand antisense oligonucleotide capabilities and infrastructure on campuses that already produce drugs such as the ALS therapy Qalsody.

Companies have improved their recovery processes and user controls but still lag in risk preparedness, according to the report.

The path to market for Roche’s astegolimab became more uncertain after the investigational antibody failed to significantly lower disease exacerbation rates versus placebo in patients with chronic obstructive pulmonary disease.

The lawsuit argues the rule would drive up the number of uninsured and saddle states with increased healthcare expenses.

Roche and Genentech were unable to sufficiently demonstrate the benefit of using Columvi in an earlier treatment setting for DLBCL in a U.S. population, according to the FDA.

Otsuka and Lundbeck’s data are insufficient to establish significant efficacy of Rexulti plus sertraline in PTSD, according to the FDA’s outside experts.

In light of recent patient deaths, the FDA has also revoked its platform designation for Sarepta’s AAVrh74 technology. The designation, granted last month, was the first of its kind to be announced publicly.

El mieloma múltiple es un tipo de cáncer hematológico que se expande en la médula ósea y que ha experimentado avances significativos en el tratamiento. En la actualidad, se estima que la tasa de supervivencia libre de progresión supera el 80% a los cinco a&n …