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Results For "United-States"

860 News Found

Lupin launches Merzee capsules in the United States
Drug Approval | April 07, 2022

Lupin launches Merzee capsules in the United States

Merzee is a generic equivalent of Taytulla of Allergan Pharmaceuticals International


Lupin launches Sevelamer Hydrochloride tablets in the United States
Drug Approval | March 01, 2022

Lupin launches Sevelamer Hydrochloride tablets in the United States

Sevelamer Hydrochloride tablets, 800 mg is a generic equivalent of Renagel tablets, 800 mg


Lupin receives tentative approval from USFDA for Oxcarbazepine ER Tablets
Drug Approval | June 09, 2025

Lupin receives tentative approval from USFDA for Oxcarbazepine ER Tablets

Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)


Sanofi exercises license extension option to Nurix’s STAT6 program
Biopharma | June 04, 2025

Sanofi exercises license extension option to Nurix’s STAT6 program

his is the second license extension of a Nurix autoimmune disease program by Sanofi in the last 90 days


Zydus receives tentative approval from USFDA for Rifaximin Tablets, 550 mg
Drug Approval | June 02, 2025

Zydus receives tentative approval from USFDA for Rifaximin Tablets, 550 mg

Rifaximin tablets had annual sales of US$ 2672.9 mn in the United States (IQVIA MAT March 2025)


Arvinas and Pfizer's Vepdegestrant significantly improves progression-free survival for patients with ESR1-Mutant, ER+/HER2- advanced breast cancer
Diagnostic Center | June 02, 2025

Arvinas and Pfizer's Vepdegestrant significantly improves progression-free survival for patients with ESR1-Mutant, ER+/HER2- advanced breast cancer

Vepdegestrant is the first and only PROteolysis TArgeting Chimera (PROTAC) evaluated in a Phase 3 clinical trial and the first to show benefit in patients with breast cancer


Keytruda plus Trodelvy reduced risk of disease progression by 35% V/s Keytruda plus cchemothrapy in first-line PD-L1+ TNBC
Diagnostic Center | June 02, 2025

Keytruda plus Trodelvy reduced risk of disease progression by 35% V/s Keytruda plus cchemothrapy in first-line PD-L1+ TNBC

First pivotal Phase 3 trial to show superiority of Keytruda plus a TROP2 antibody-drug conjugate, Trodelvy, versus standard of care in first-line metastatic TNBC


Merck’s MK-1084 shows antitumor activity in Phase 1 trial of patients with advanced colorectal cancer
News | May 31, 2025

Merck’s MK-1084 shows antitumor activity in Phase 1 trial of patients with advanced colorectal cancer

Manageable safety profile and encouraging antitumor activity observed for MK-1084 in KANDLELIT-001, both as a monotherapy and in studied combinations


Merck withdraws Biologics License Application for Patritumab Deruxtecan
Drug Approval | May 30, 2025

Merck withdraws Biologics License Application for Patritumab Deruxtecan

The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance


Fluor-built Bayer cell therapy facility in California achieves LEED v4 platinum certification
News | May 28, 2025

Fluor-built Bayer cell therapy facility in California achieves LEED v4 platinum certification

Facility also named 2025 ISPE Facility of the Year Winner for Social Impact - Unmet Medical Needs