Legend's LB2501 in vivo CAR-T cell therapy demonstrated complete responses in all higher-dose patients with non-Hodgkin lymphoma, sparking investor enthusiasm and positioning it as potential rival to ex vivo therapies.

Long-term follow-up data from the KEYNOTE-942 trial showed that combining Moderna's personalized mRNA vaccine with Merck's Keytruda reduced melanoma recurrence risk by nearly 50% and extended cancer-free survival.

Abivax's obefazimod achieved best-in-disease efficacy in ulcerative colitis with 40% improvement over placebo, but multiple cancer cases in the trial sparked investor flight and endangered takeover prospects.

New FDA guidance permits sponsors to use previously generated CMC and scientific knowledge to accelerate gene therapy development and regulatory submissions for rare diseases.

Early data for the RAS inhibitor daraxonrasib showed it doubled median survival in pancreatic cancer patients at ASCO 2026, addressing a cancer historically resistant to targeted therapy.

A Belgian-developed gene therapy targeting age-related hearing loss became the first in its class to gain FDA clearance, addressing a significant unmet need in older adults.

The longevity-focused startup secured one of the year's largest venture rounds to advance its first clinical-stage liver medicine targeting cellular aging.

Lilly will pay up to $1.9 billion to Ascidian Therapeutics to discover and develop RNA exon-editing therapeutics for genetically driven kidney diseases.

The South Korean company won FDA backing for a streamlined single pivotal Phase 3 study with confirmatory evidence strategy for its cartilage regeneration therapy in the U.S. market.

Fulcrum discontinued its lead sickle cell therapy after the FDA cited cancer risk concerns, joining Pfizer, Novartis, and Intellia in recent sickle cell drug setbacks.

Voyager Therapeutics received FDA clearance to begin clinical trials of its gene therapy designed to target tau protein pathology in Alzheimer's disease.

The White House plans to remove job protections from thousands of senior NIH positions overseeing research grants and agency operations.

Roche's late-stage oral SERD drug giredestrant failed to meet primary efficacy endpoints in first-line breast cancer but showed sufficient promise for adjuvant development.

Alnylam agreed to a three-year deal worth up to $2 billion with Inceptive to apply AI-designed RNA foundation models for RNAi drug development.

Celcuity's gedatolisib demonstrated efficacy against Piqray in PIK3CA-mutated breast cancer at ASCO, with investigators calling it potentially practice-changing, though stock remained under pressure.

Lilly snapped up a GLP-2 obesity drug candidate from a Houston biotech startup for $300 million as Big Pharma continues aggressive dealmaking in the weight loss space.

GenScript's ivonescimab bispecific presentation at ASCO 2026 highlighted China's advancing capability in cancer drug innovation and development.

BMS's EGFRxHER3 bispecific ADC, acquired for $800 million, demonstrated efficacy competitive with blockbuster TROP2-targeted agents in TNBC.

Budget reductions to NIH-funded centers damaged relationships and capacity among experts involved in outbreak preparedness and infectious disease surveillance.

Roche achieved NDA acceptance for its oral SERD giredestrant in early-stage breast cancer, keeping the megablockbuster potential alive despite first-line disappointment.

A proposed amendment to add biotechnology to the CFIUS review process targets major drug deals involving Chinese companies, citing national security concerns.

Vera progressed toward full FDA approval of its kidney disease therapy following a successful Type C meeting with regulators on the drug's path forward.

Lilly gave participating 340B hospitals five days to submit claims data verifying compliance with drug discount rules or face loss of program benefits.

The British medtech startup raised significant funding to advance its single-blood-sample immune profiling technology from analog to high-definition diagnostics.