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Apitoria Pharma receives 5 observations from USFDA for API facility
Drug Approval | August 31, 2025

Apitoria Pharma receives 5 observations from USFDA for API facility

At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported


Novo Nordisk’s Wegovy cuts risk of heart attack, stroke or death by 57% compared to tirzepatide
News | August 31, 2025

Novo Nordisk’s Wegovy cuts risk of heart attack, stroke or death by 57% compared to tirzepatide

The study showed a significant 29% reduction in the risk for heart attack, stroke and death from any cause in the Wegovy users


FDA suspends Valneva’s license of chikungunya vaccine IXCHIQ in US
Drug Approval | August 31, 2025

FDA suspends Valneva’s license of chikungunya vaccine IXCHIQ in US

The sudden subsequent decision to suspend IXCHIQ is based on updated VAERS data


FDA approves Teva Pharmaceuticals' first GLP-1 obesity drug
Drug Approval | August 29, 2025

FDA approves Teva Pharmaceuticals' first GLP-1 obesity drug

Generic Saxenda is the first-ever generic GLP-1 indicated for weight loss, addressing increased demand for this category of therapies in the US market


Piramal Pharma Solutions supports George Medicines in developing new drug for hypertension
News | August 29, 2025

Piramal Pharma Solutions supports George Medicines in developing new drug for hypertension

WIDAPLIK is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals


Lilly's oral GLP-1 orforglipron succeeds in Phase 3 trial
News | August 29, 2025

Lilly's oral GLP-1 orforglipron succeeds in Phase 3 trial

Triggering global regulatory submissions this year for the treatment of obesity


Zydus Therapeutics reports positive phase-3 results in rare liver disease
News | August 29, 2025

Zydus Therapeutics reports positive phase-3 results in rare liver disease

Saroglitazar was generally well tolerated, with overall adverse events generally balanced between Saroglitazar-treated and placebo-treated patients


Gilead’s Yeytuo approved in EU for HIV prevention
Drug Approval | August 28, 2025

Gilead’s Yeytuo approved in EU for HIV prevention

This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option


FDA expands Repatha indication to adults at risk of major cardiovascular events from uncontrolled LDL-C
News | August 28, 2025

FDA expands Repatha indication to adults at risk of major cardiovascular events from uncontrolled LDL-C

The FDA also expanded Repatha’s use as monotherapy to include patients with homozygous familial hypercholesterolemia