This regulatory relief, combined with several other compelling catalysts, creates a pathway for the stock to potentially ...

The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...

Susan Monarez, Ph.D., was confirmed by the Senate Tuesday as director of the Centers for Disease Control and Prevention (CDC) ...

The U.S. Food and Drug Administration (FDA) is investigating the death of an eight-year-old boy who received Sarepta ...

Sarepta Therapeutics Inc. (NASDAQ:SRPT) stock declined 13% Friday after European regulators recommended against approving Elevidys, the company’s gene therapy for Duchenne muscular dystrophy.

HCA Healthcare raises 2025 profit forecast amidst insurance uncertainty while Centene anticipates a 2026 profitability boost ...

Second-quarter earnings come amid many high-level challenges for the biopharma industry. How will these five closely watched ...

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

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EMA’s CHMP issued an opinion not to recommend Elevidys™ (delandistrogene moxeparvovec) for the treatment of ambulatory individuals with Duchenne muscular dystrophy (DMD) Roche will continue its ...

Analysts are intrested in these 5 stocks: ( ($ETSY) ), ( ($CLS) ), ( ($BIIB) ), ( ($SRPT) ) and ( ($M) ). Here is a breakdown of their recent ...

EMA's CHMP issued an opinion not to recommend Elevidys (delandistrogene moxeparvovec) for the treatment of ambulatory individuals with Duchenne muscular dystrophy (DMD) Roche will continue its dialogu ...