Expanded indication broadens use of combination nasal spray to pediatric patients aged six years and above in the United States
The company to commercialize the oncology drug in the U.S.; reference product Lynparza recorded a market size of nearly USD 1.4 billion
The approval is supported by results from Novo Nordisk’s OASIS clinical trial programme
TolerogenixX is developing MIC-Lx as a personalized cell therapy designed to induce donor-specific immune tolerance before living-donor kidney transplantation
Leiutis Pharmaceuticals and Zenara Pharma secure world's first approval for fully synthetic CBD therapy for mild to moderate anxiety
The study demonstrated a 47% reduction in the risk of tumor recurrence, progression or death,
The deal further strengthens company's respiratory pipeline as the company continues to expand its portfolio across chronic respiratory diseases.
While semaglutide is already authorised for weight management in adults and adolescents, as well as reducing cardiovascular events in adults.
The drug is now approved for adults with locally advanced or metastatic gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma
The listing covers the first test capable of detecting Ebola Bundibugyo virus disease by identifying its genetic material in blood samples
Sobi said it will request a meeting with the FDA to review the feedback
The approval is based on results from the pivotal Phase 3 KEYNOTE-905 trial
Backed by Phase 3 trial showing 24% lower risk of progression
CDSCO-approved targeted therapy expands precision oncology options for patients with RET-driven lung, thyroid, and other advanced solid tumours
Approval makes it the first and only therapy in the EU indicated for both acute and chronic hepatitis C, supported by Phase 3 data
The filing is backed by positive Phase 3 results recently published in JAMA Neurology
The FDA has granted Priority Review, setting a target decision date of 9 October 2026, potentially accelerating access to a new treatment option for a subset of patients with high-risk colon cancer characterized
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