Regardless, Insmed still needs to conduct a Phase 3 trial, which isn't expected to begin until next year, followed by an FDA approval requirement.

The FDA in 2022 announced a ban on the sale of Juul e-cigarettes nationwide, saying the company did not prove that keeping its products on the market “would be appropriate for the protection of ...

FDA Commissioner Marty Makary, M.D., has made his pick for the next director of the FDA’s Center for Drug Evaluation and Research (CDER) in veteran biotech executive George Tidmarsh, M.D., Ph.D.

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental treatment ...

The FDA has rejected Replimune’s request for approval of RP1, adding the melanoma drug candidate to the list of assets to receive complete response letters from the new-look agency.

Replimune stock fell after the FDA rejected its RP1 application, citing flaws in the trial design and lack of substantial evidence for approval.

Wells Fargo analyst Tiago Fauth maintained a Buy rating on Insmed Incorporated (NASDAQ:INSM) on July 22, raising the associated price target to $130 from $119.

Sarepta will continue to ship its gene therapy Elevidys to DMD patients who can still walk independently, arguing the data support the drug's safety.

FDA regulators said Juul's studies show its e-cigarettes are less harmful for adult smokers, who can benefit from switching completely to vaping.

An FDA expert panel has reignited a decades-old debate over hormone therapy treatment for menopause, as advocates argue over black box warnings and and a controversial 20th-century study.

Teachers Retirement System of The State of Kentucky acquired a new stake in Insmed, Inc. (NASDAQ:INSM – Free Report) during the first quarter, according to its most recent disclosure with the ...

An FDA advisory panel concludes that the efficacy of brexpiprazole, when started concurrently with sertraline, has not been established for the treatment of PTSD.