The FDA requires an additional 3 months to review a major amendment to the Biologics License Application for deramiocel, ...

Investigational siRNA therapeutic targeting prekallikrein receives FDA Fast Track designation following promising phase 1/2 data in HAE.

Subcutaneous autoinjector formulation expands starting treatment options for mild cognitive impairment and mild dementia due ...

Avulux is the first FDA-authorized precision optical filter indicated to help manage light sensitivity associated with ...

On average, onset is 2.5 years earlier compared with nonusers, but differences increase with age. HealthDay News — Cannabis users may have an earlier age at onset (AAO) of psychosis than nonusers, ...

Of the 1,357 AI devices authorized by the FDA, only three had evidence of clinical effectiveness and only 34 had registered clinical trials ...

HealthDay News — Combining chemotherapy with immunotherapy before surgery for head and neck cancer is associated with significantly greater reductions in tumor size than immunotherapy alone, according ...

Rate increased sharply after press release announcing leucovorin label would be updated to include cerebral folate deficiency.

One phlebotomist can oversee up to 3 Aletta machines, directly helping to address the current phlebotomist shortage and long ...

Intismeran autogene is a personalized mRNA therapy that targets a tumor's unique mutational signature to trigger an anticancer immune response.

While study did not reveal a causal link, authors advise reducing exposure, particularly to products with fragrances.

The approval was supported by data from the phase 3 OPTIMA trial, which enrolled 63 adults with FOP confirmed by an ACVR1 FOP ...