Whoop pushed back on the warning letter, claiming its blood pressure feature for a wearable wristband is for “wellness” and should not be regulated as a medical device.
Whoop’s FDA warning letter sparks debate over blood pressure as a wellness metric Read More »
The rollercoaster week for Sarepta Therapeutics continued, with shares of the embattled gene therapy-turned-siRNA biotech down 37% Friday afternoon as media outlets reported FDA plans to request a stop to all shipments of the Duchenne muscular dystrophy therapy Elevidys following a third patient death linked to the underlying platform.
Sarepta Craters as FDA Considers Requesting Halt to Elevidys Shipments Read More »
On Thursday, CMS sent letters to states notifying them that it doesn’t plan to approve any new such waivers or extend existing ones in the administration’s latest curtailing of Medicaid.
It’s a significant loss for the insurer, which sued the government late last year after its star ratings plummeted for 2025. Analysts estimate Humana could lose billions of dollars as a result of the decision.
Judge dismisses Humana’s Medicare Advantage star ratings suit Read More »
Civil monetary penalties against payers for improperly delaying or denying coverage, hitting members with higher cost sharing than allowed and other issues have already surpassed $3 million this year.
The health system alleges Ralph de la Torre and other former leaders “pilfered” the company’s assets and led to its collapse last year.
Bankrupt Steward sues former CEO over alleged financial mismanagement Read More »
Despite the failure, BMS remains “encouraged” by Reblozyl’s clinical activity in myelofibrosis-associated anemia and will approach regulators to discuss potential submissions for this indication, for which few treatment options exist.
BMS’ Anemia Drug Reblozyl Flunks Phase III Myelofibrosis Trial Read More »
The patient, who was being treated with an investigational gene therapy for limb-girdle muscular dystrophy, died of acute liver failure, the same complication responsible for the deaths of two boys taking Sarepta’s Duchenne muscular dystrophy treatment Elevidys.
Sarepta Reports a Third Gene-Therapy Related Patient Death Read More »
The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug conjugate in multiple myeloma.
GSK’s Blenrep Loses Adcomm Vote, Further Clouding Comeback Bid Read More »
Unos científicos han demostrado que es posible hacer crecer algas verdes dentro de refugios hechos de bioplástico bajo condiciones como las reinantes en Marte. Estos experimentos son un primer paso para diseñar hábitats sostenibles en Marte que no requieran traer de la Ti …
Algas verdes cultivables en Marte gracias a un bioplástico especial Read More »
