GSK wins FDA approval for Jideytro after Nuvalent acquisition
ROS1-targeted therapy becomes GSK's first marketed lung cancer drug, expanding its oncology portfolio
ROS1-targeted therapy becomes GSK's first marketed lung cancer drug, expanding its oncology portfolio
The authorization permits the study to commence at the clinical centers included in the approved application
Lilly said it plans to submit a Biologics License Application (BLA) for retatrutide to the U.S. Food and Drug Administration in the first quarter of 2027
The expanded indication is backed by results from a Phase 3 randomized, double-blind, placebo-controlled study
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
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