Vandana Singh

1 week ago | benzinga.com | Vandana Singh

The U.S. Food and Drug Administration (FDA) announced its Commissioner's National Priority Voucher (CNPV) program. What Happened: The FDA aims to modernize its regulatory framework to meet emerging public health needs. Drug developers may redeem the new voucher to participate in the FDA’s novel priority program, which shortens the review time from approximately 10-12 months to 1-2 months following a sponsor's final drug application submission.

1 week ago | benzinga.com | Vandana Singh

Gilead Sciences Inc GILD is facing mounting pressure to price its long-acting HIV prevention drug, lenacapavir, affordably as it prepares for U.S. regulatory approval on June 19. In December 2022, the FDA approved Lenacapavir in combination with other antiretrovirals to treat HIV-1 infection in heavily treatment-experienced adults with multi-drug resistant HIV-1 infection.

1 week ago | benzinga.com | Vandana Singh

Fresenius Medical Care AG (NYSE:FMS) on Tuesday introduced a strategic roadmap — FME Reignite — aimed at revitalizing its core business, driving innovation and reshaping its organizational culture. By 2030, it targets operating income margins in the mid-teens in its Care Delivery and Care Enablement segments and low single-digit margins in Value-Based Care. The company also announced an expansion of its FME25 cost-savings program, now called FME25+.

1 week ago | benzinga.com | Vandana Singh

Fresenius Medical Care AG FMS on Tuesday introduced a strategic roadmap — FME Reignite — aimed at revitalizing its core business, driving innovation and reshaping its organizational culture. By 2030, it targets operating income margins in the mid-teens in its Care Delivery and Care Enablement segments and low single-digit margins in Value-Based Care. The company also announced an expansion of its FME25 cost-savings program, now called FME25+.

1 week ago | benzinga.com | Vandana Singh

Dyne Therapeutics, Inc. DYN stock is trading lower after the company announced on Tuesday that it had revised the ongoing Registrational Expansion Cohort in the Phase 1/2 ACHIEVE trial for DYNE-101 for myotonic dystrophy type 1 (DM1). The primary endpoint is a change from baseline in middle finger myotonia as measured by vHOT at 6 months, compared to placebo. • Video hand opening time (vHOT) measures hand function and myotonia (delayed relaxation of skeletal muscles after voluntary contraction).