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Results For "United-States"

958 News Found

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
Clinical Trials | 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
Clinical Trials | 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


CPHI & PMEC China sees surge in international attendance
News | May 24, 2025

CPHI & PMEC China sees surge in international attendance

Record international participation reflects renewed momentum in pharma manufacturing and global sourcing, as easing tariffs fuel growth


Zydus receives final approval from USFDA for Isotretinoin Capsules USP
Drug Approval | May 24, 2025

Zydus receives final approval from USFDA for Isotretinoin Capsules USP

Isotretinoin capsules are indicated to treat severe, disfiguring nodular acne