GSK’s Gepotidacin Granted Priority Review by US FDA for Gonorrhoea Treatment
The US FDA has granted priority review to GSK’s new drug application for gepotidacin, a potential new oral treatment for uncomplicated urogenital gonorrhea.
The US FDA has granted priority review to GSK’s new drug application for gepotidacin, a potential new oral treatment for uncomplicated urogenital gonorrhea.
Eyestem Research has successfully closed an oversubscribed funding round, securing $10 million to accelerate the development of Eyecyte-RPEâ„¢, its investigational cell therapy for dry age-related macular degeneration (dry AMD).
Eli Lilly and Company announced that its investigational oral GLP-1 receptor agonist, orforglipron, delivered an average weight loss of 27.3 lbs in the Phase 3 ATTAIN-1 trial. The once-daily pill demonstrated a safety profile consistent with existing injectable GLP-1 therapies and also showed improvements in cardiovascular risk factors.
Eli Lilly and Company reported strong second-quarter 2025 financial results, with worldwide revenue increasing 38% to $15.56 billion. This growth was driven by a 42% increase in volume, particularly from the company’s key products Zepbound and Mounjaro. Reported earnings per share (EPS) for the quarter were $6.29, a 92% increase compared to the same period in 2024. Following these results, Lilly has raised its full-year 2025 revenue guidance to a range of $60.0 billion to $62.0 billion.
Pfizer delivered robust Q2 2025 results, reporting $14.7 billion in revenue (up 10% operationally) and $0.78 adjusted EPS. Key drivers included double-digit growth from Comirnaty, Paxlovid and Abrysvo. The company raised its full-year adjusted EPS guidance to $2.90–3.10 while reaffirming revenue outlook of $61.0–64.0 billion, underscoring strong commercial execution and cost-saving initiatives.
Allogene Therapeutics, a clinical-stage biotechnology company, has selected the standard fludarabine and cyclophosphamide (FC) as the lymphodepletion regimen for its ALPHA3 study.
The U.S. FDA has declined to approve an expanded indication for Johnson & Johnson’s multiple myeloma therapy, Darzalex Faspro. The decision, delivered via a Complete Response Letter, was not based on the drug’s clinical efficacy but on unresolved issues at a third-party manufacturing facility.
AbbVie reports positive topline results from its Phase 3 UP-AA trial, showing upadacitinib (RINVOQ) significantly improved scalp hair coverage in patients with severe alopecia areata.
Eli Lilly and Company announced results from the long-term extension of the Phase 3 TRAILBLAZER-ALZ 2 study, demonstrating that participants treated with Kisunla (donanemab-azbt) for early symptomatic Alzheimer’s disease showed a continued slowing of decline over three years.
AstraZeneca‘s supplemental biologics license application (sBLA) for Imfinzi (durvalumab) has been approved and given priority review in the U.S. FDAÂ for the treatment of patients with [Read More…]