FDA approval

The group’s 7-2 ruling in favor of the therapeutic represents a shift from previous deliberations, in which data on its effectiveness was deemed insufficient.

No deaths had previously been associated with the muscle-wasting treatment Zolgensma.

Agency members express hope that the availability of a traditional, protein-based vaccine might convince holdouts to get vaccinated.

Moderna and Pfizer-BioNTech shots could be given to the youngest kids as early as June 21.

The achievement bolsters hopes that nonhuman animals could be used to remedy the shortage of transplantable organs.

Merck reports that its antiviral molnupiravir was effective against early stages of COVID-19 in high-risk patients in a Phase 3 clinical trial.

President Biden’s planned rollout of additional COVID-19 vaccine doses is set to begin next week, but questions remain about who should get them.

The FDA granted the drug, called Aduhelm, accelerated approval earlier this summer in a process that’s since drawn scrutiny.

The milestone marks the first fully-approved COVID-19 vaccine in the United States.

The US Food and Drug Administration has called for a federal investigation of its own regulatory review process after widespread criticism of its decision on Aduhelm.

A lackluster performance in clinical trials of the monoclonal antibody aducanumab has left some experts unconvinced of its benefit.

With multiple microbiota therapeutics in the pipeline for recurrent Clostridium difficile infection, clinicians foresee a shift in treatment options for the condition.

The decision, which concerns the removal of a sugar molecule on the surface of cells in a line of domestic pigs, marks the first time an approval has been granted for both purposes simultaneously.

As COVID-19 therapies get emergency-use green lights, the Biden administration must organize a therapeutic review board to help identify what’s working and what’s not.

Two new medications for treating a rare and deadly neuromuscular disease have high prices and questionable efficacies, say scientists.

White House officials hail convalescent plasma as a major breakthrough, but scientists say evidence supporting its effectiveness is still lacking.

Vaccine experts divided on whether that level of protection is too low or too demanding.

Abbott’s ID NOW test missed the most positive samples among five products given the green light by the FDA to use during the pandemic.