Health
Rezolute receives FDA guidance for ersodetug pre-BLA meeting
Rezolute (NASDAQ:RZLT) announced that the U.S. Food and Drug Administration recommended a pre-BLA meeting prior to any potential biologics license application for ersodetug.
United States Health
Health
Stoke Therapeutics reviews 5-year data at FDA meeting
Stoke Therapeutics (NASDAQ:STOK) announced the successful completion of a meeting with the U.S. Food and Drug Administration regarding its investigational zorevunersen treatment.
Health
ANI Pharmaceuticals eye implant trial meets endpoints
ANI Pharmaceuticals (NASDAQ:ANIP) announced results from the U.S. open-label, single-arm Phase 4 SYNCHRONICITY study evaluating fluocinolone acetonide intravitreal implant 0.18 mg in patients with chronic non-infectious inflammation affecting the back of the eye.
Health
Summit Therapeutics completes $2 billion AstraZeneca equity investment
Summit Therapeutics (NASDAQ:SMMT) completed a $2 billion strategic equity investment from AstraZeneca (NASDAQ:AZN) to advance its clinical oncology pipeline.
Health
Vaxcyte VAX-31 meets all primary endpoints in Phase 3 trial
Vaxcyte (NASDAQ:PCVX) reported that VAX-31 met all prespecified primary endpoints in its OPUS-1 Phase 3 trial.
Health
Alvotech secures FDA approval for second SIMLANDI production suite
Alvotech (NASDAQ:ALVO) received U.S. FDA approval to manufacture SIMLANDI drug substance in a second production suite at its Reykjavik facility.
Health
Novartis signs $7.8 billion Abogen RNA deal
Novartis (NYSE:NVS) signed a licensing and option agreement with privately held Abogen Biosciences worth up to about $7.8 billion for ABO2203 and other potential RNA-based programs.
Health
Surrozen secures FDA clearance for SZN-8141 and $95.1 million financing
Surrozen (NASDAQ:SRZN) received U.S. FDA clearance of its investigational new drug application for SZN-8141, enabling clinical development for diabetic macular edema.
Health
Teva highlights positive efficacy and safety data for ecopipam
Teva (NYSE:TEVA) announced new efficacy and safety analyses of ecopipam, its investigational treatment for pediatric patients with Tourette syndrome.
Health
Integra LifeSciences lowers 2026 revenue guidance
Integra LifeSciences (NASDAQ:IART) lowered its full-year 2026 revenue guidance to between $1.634 billion and $1.654 billion following a severe flood at its Cincinnati production facility.
Health
Johnson & Johnson reports sustained psoriasis skin clearance
Johnson & Johnson (NYSE:JNJ) announced Phase 3 clinical results showing sustained skin clearance with ICOTYDE for plaque psoriasis.
Health
Moderna rises 2.2% on Nasdaq-100 inclusion
Moderna (NASDAQ:MRNA) shares climbed 2.2% to $193.01 premarket after Nasdaq said the vaccine maker will replace Warner Bros. Discovery (NASDAQ:WBD) in the Nasdaq-100 Index on October 9.