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Results For "FDA-approval"

460 News Found

FDA approves Teva’s expanded indication for Uzedy for bipolar I disorder
Drug Approval | October 11, 2025

FDA approves Teva’s expanded indication for Uzedy for bipolar I disorder

UZEDY (risperidone) extended-release injectable suspension for subcutaneous use is indicated for use every one or two months for the treatment of schizophrenia in adults


FDA approves Roche’s Tecentriq + lurbinectedin as first-line maintenance therapy for lung cancer
Drug Approval | October 05, 2025

FDA approves Roche’s Tecentriq + lurbinectedin as first-line maintenance therapy for lung cancer

Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte study


Novo Nordisk’s Wegovy delivered 16.6% weight loss
News | September 18, 2025

Novo Nordisk’s Wegovy delivered 16.6% weight loss

Wegovy achieved significant weight loss with one in three study participants losing 20% or more body weight


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


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


Xspray Pharma licenses patent rights to Handa Therapeutics, secures royalty agreement
News | August 17, 2025

Xspray Pharma licenses patent rights to Handa Therapeutics, secures royalty agreement

Its lead product, Dasynoc, is awaiting FDA approval with a PDUFA date of October 7, 2025


Biocon Q1 FY26 PAT slips 95% to Rs. 31.4 Cr
News | August 08, 2025

Biocon Q1 FY26 PAT slips 95% to Rs. 31.4 Cr

Revenue from operations rose 14.8 per cent year-on-year to Rs. 3,942 crore


Sun Pharmaceutical Q1 FY26 consolidated PAT falls by 20% to Rs. 2,278 Cr
News | August 02, 2025

Sun Pharmaceutical Q1 FY26 consolidated PAT falls by 20% to Rs. 2,278 Cr

India Formulation sales accounted for 34.2% of total consolidated sales for the quarter