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The Korean company claims its four-hormone candidate beats triple-action rivals while preserving muscle, positioning it in the crowded obesity race.

A priority review shortens the agency's decision timeline for what would be the first gene therapy for the inherited neurodegenerative disease.

The close vote could open the door for compounded versions of popular peptide therapies, a closely watched front in the GLP-1 supply battle.

The cuts show the company trimming early-stage programs even as it pushes into China's obesity market and touts its late-stage portfolio.

The expanded label moves the BTK inhibitor into front-line use for chronic lymphocytic leukemia and small lymphocytic lymphoma.

The hold on the Phase 2 seizure study clouds the biotech's lead program after animal toxicity findings.

The nod marks a major step for low-cost oral GLP-1 competition in one of the world's largest generic markets.

Experts applaud the pricing move but say bigger access concerns remain, while AstraZeneca won a court reprieve from NPPA action.

The unusual investigator letter pressures the agency ahead of a decision on the Duchenne muscular dystrophy cell therapy.

The review of Lilly's dealmaking comes as its weight-loss franchise pushes the stock toward record highs and attention shifts to hair loss assets.

The designation could speed development and review of the Korean biotech's candidate in a cancer type with limited options.

Domestic pricing data show the homegrown therapy undercutting imported rivals by 26 to 44 percent as Korea's obesity market intensifies.

The coming wave of biosimilars to Merck's blockbuster faces entrenched payer and prescribing patterns.

The company is betting its late entrant status in China can be offset by consumer-branding tactics previously used for erectile dysfunction drugs.

Both countries are accelerating GLP-1 and related programs, with Chinese developers currently ahead in the regional race.

The voucher sale illustrates how rare pediatric disease review incentives have become a material revenue source for biotechs.

The deal is one of the largest such voucher sales, converting rare disease approvals into upfront cash.

Repeated failures by large developers are opening licensing opportunities for Korean companies with alternative approaches.

US demands for higher European drug prices could eventually bring more new medicines to market, but the near-term pressure is on governments.

The early-stage trial marks another step for in vivo gene editing in a disease with no curative options.

The infection reduction supports the microbiome therapy's potential in transplant patients.

Market forecasts project the obesity therapeutics sector reaching about $95 billion by 2035 as GLP-1 use spreads.

The launch with reimbursement gives SK's branded antiseizure drug a commercial footing in its home market.

The result supports the company's pathogen-reduction approach to treating donated blood.

An early stop for efficacy suggests a new option for managing a common side effect that forces dose reductions.

Facing reimbursement pressure, Korean manufacturers are pivoting toward contract manufacturing and differentiated products.

The Korean company is highlighting delivery technology as a differentiating asset in partnering discussions.

The change loosens access requirements for the pediatric therapy, broadening its real-world use.

About 155,000 people in the US have the blood cancer targeted by the multinational trial.

Policy analysts say Korea's ecosystem needs changes to capture renewed global interest in natural-product medicines.

The Korean company's long investment in novel drug development is beginning to yield commercial results.

The system overhaul aims to modernize oversight of the country's large pharmaceutical market.

The scheduled update comes as the regenerative medicine company navigates its commercial launch.