Zydus Lifesciences has received tentative FDA approval for dapagliflozin tablets in 5 mg and 10 mg strengths. The drug, used to treat type 2 diabetes, will be manufactured at the company’s SEZ facility in Ahmedabad.
NATCO Pharma gets USFDA tentative approval for its generic Erdafitinib, a treatment for advanced urothelial carcinoma, offering a more affordable option for cancer patients.
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AstraZeneca and Daiichi Sankyo’s Datroway has received FDA Priority Review for unresectable or metastatic triple-negative breast cancer patients who are not eligible for immunotherapy, marking a key regulatory milestone.
Pfizer announced positive phase 2b results for PF’3944, showing that monthly dosing delivered up to 12.3% placebo-adjusted weight loss while maintaining safety in adults with obesity or overweight without diabetes.
Sun Pharma Advanced Research Company has secured an FDA Priority Review Voucher tied to its neonatal seizure drug Sezaby, strengthening its regulatory position and offering strategic flexibility for future drug approvals.
AstraZeneca’s subcutaneous Saphnelo application rejected by FDA, delaying approval until 2026. However, it remains approved in the EU for treating lupus patients.
Lupin partners with TB Alliance to fast-track the clinical development and commercialization of Telacebec for treating TB, leprosy, and other mycobacterial infections.
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AstraZeneca Pharma India has received CDSCO approval for Durvalumab with FLOT chemotherapy, making it the first perioperative immunotherapy option for adults with resectable gastric and gastroesophageal junction cancer.
Indoco Remedies has received USFDA approval for its ANDA for Lacosamide Oral Solution, a generic version of Vimpat. The approval strengthens the company’s growing footprint in the U.S. generics market.
.png "Novo Nordisk's Obesity Drug CagriSema Beats Wegovy In Trial")
Novo Nordisk said today that its next-generation obesity drug CagriSema delivered better weight loss and blood sugar control than Wegovy in a late-stage diabetes trial, strengthening its pipeline in the fast-growing market.
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