Lupin has launched Topiramate Extended-Release Capsules in the U.S. after receiving FDA approval for its ANDA, expanding access to treatments for epilepsy and migraine prevention.
The CDSCO has issued a draft guidance document to help IVD medical device importers file import license applications online through the CDSCO portal and the National Single Window System, aiming to ensure faster and accurate approvals.
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.
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