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Results For "prescription-drug"

104 News Found

Merck’s DOR/ISL regimen shows minimal impact on weight and lipids in phase 3 HIV studies
Clinical Trials | October 16, 2025

Merck’s DOR/ISL regimen shows minimal impact on weight and lipids in phase 3 HIV studies

These findings follow positive Phase 3 results presented earlier this year


FDA launches crackdown on deceptive drug advertising
Policy | September 16, 2025

FDA launches crackdown on deceptive drug advertising

The FDA is beginning rulemaking to close the “adequate provision” loophole


Milestone Pharmaceuticals announces FDA acceptance of response to Cardamyst nasal spray CRL
Drug Approval | July 15, 2025

Milestone Pharmaceuticals announces FDA acceptance of response to Cardamyst nasal spray CRL

Milestone also announced the extension of its $75 million Royalty Purchase Agreement with RTW Investments


FDA accepts new drug application for Merck’s Doravirine/Islatravir
Drug Approval | July 11, 2025

FDA accepts new drug application for Merck’s Doravirine/Islatravir

The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act


Linerixibat new drug application accepted for review by the USFDA for cholestatic pruritus in patients with PBC
News | June 07, 2025

Linerixibat new drug application accepted for review by the USFDA for cholestatic pruritus in patients with PBC

If approved, linerixibat could address high unmet medical need of patients living with cholestatic pruritus (relentless itch) and related sleep interference


FDA approves Opdivo plus Yervoy as treatment metastatic colorectal cancer
Drug Approval | April 12, 2025

FDA approves Opdivo plus Yervoy as treatment metastatic colorectal cancer

The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date


Boehringer's zongertinib receives Priority Review from USFDA for the treatment of HER2 mutant advanced non-small cell lung cancer
Drug Approval | February 20, 2025

Boehringer's zongertinib receives Priority Review from USFDA for the treatment of HER2 mutant advanced non-small cell lung cancer

Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC), if approved


BMS receives positive CHMP opinion for Opdivo plus Yervoy as a first-line treatment option for advanced hepatocellular carcinoma
News | February 01, 2025

BMS receives positive CHMP opinion for Opdivo plus Yervoy as a first-line treatment option for advanced hepatocellular carcinoma

Recommendation based on results of Phase 3 CheckMate -9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population


Zydus announces USFDA Orphan Drug Designation to Usnoflast for treatment of ALS
Drug Approval | January 23, 2025

Zydus announces USFDA Orphan Drug Designation to Usnoflast for treatment of ALS

The company is committed to unlocking new frontiers in neuroscience and developing Usnoflast for patients with ALS


Sunshine Biopharma launches Olanzapine and Olanzapine ODT
News | January 22, 2025

Sunshine Biopharma launches Olanzapine and Olanzapine ODT

Olanzapine is indicated for the acute and maintenance treatment of schizophrenia and related psychotic disorders