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Results For "United-States"

964 News Found

Zydus receives final approval from the USFDA for Sugammadex Single-Dose Vial
Drug Approval | October 09, 2023

Zydus receives final approval from the USFDA for Sugammadex Single-Dose Vial

Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide


Lupin receives tentative approval from USFDA for Tolvaptan Tablets
Drug Approval | October 07, 2023

Lupin receives tentative approval from USFDA for Tolvaptan Tablets

Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)


Strides receives USFDA approval for Efavirenz, Emtricitabine & Tenofovir Disoproxil Fumurate tablets
Drug Approval | October 05, 2023

Strides receives USFDA approval for Efavirenz, Emtricitabine & Tenofovir Disoproxil Fumurate tablets

The approval adds to a list of products that Strides has approved in this therapeutic category through the PEPFAR pathway taking the total to 15 products


Strides receives USFDA approval for Icosapent Ethyl capsules
Drug Approval | October 04, 2023

Strides receives USFDA approval for Icosapent Ethyl capsules

The product is bioequivalent and therapeutically equivalent to the RLD, Vascepa of Amarin


Briefs: Aurobindo Pharma and Balaxi Pharmaceuticals
News | October 03, 2023

Briefs: Aurobindo Pharma and Balaxi Pharmaceuticals

Balaxi Healthcare Ecuador S.A.S. has become a Wholly Owned Subsidiary of the company


Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 manufacturing facility
Drug Approval | September 30, 2023

Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 manufacturing facility

The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated


Cosmo and Glenmark sign distribution and license agreements for Winlevi in Europe and South Africa
Supply Chain | September 28, 2023

Cosmo and Glenmark sign distribution and license agreements for Winlevi in Europe and South Africa

Glenmark will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to commercialize Winlevi in 15 EU countries


Briefs: Mankind Pharma and Sequent Scientific
News | September 26, 2023

Briefs: Mankind Pharma and Sequent Scientific

Mankind Pharma commences the commercial operations newly set-up plant in Udaipur


Strides receives USFDA approval for Icosapent Ethyl Capsules
Drug Approval | September 25, 2023

Strides receives USFDA approval for Icosapent Ethyl Capsules

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD)


Merck and Eisai update on Two Phase 3 Trials Evaluating Keytruda plus Lenima for cell lung cancer
Clinical Trials | September 23, 2023

Merck and Eisai update on Two Phase 3 Trials Evaluating Keytruda plus Lenima for cell lung cancer

The companies will work with investigators to share the results with the scientific community