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Results For "U.S.-FDA"

291 News Found

Lupin Q3 FY25 profit up 40% at Rs. 855 Cr
News | February 14, 2025

Lupin Q3 FY25 profit up 40% at Rs. 855 Cr

Revenue up 11% to Rs 5,768 crore as compared to Rs 5,197 crore


Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations
Drug Approval | February 03, 2025

Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations

The inspection was carried out from January 28 to February 1, 2025


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


Pfizer’s BRAFTOVI combination demonstrates improved response for mutant metastatic colorectal cancer
News | January 27, 2025

Pfizer’s BRAFTOVI combination demonstrates improved response for mutant metastatic colorectal cancer

BRAFTOVI combination regimen is the first and only targeted therapy approvedby the U.S. FDA for treatment-naïve patients with metastatic colorectal cancer with a BRAF V600E mutation


Bayer’s pharma growth strategy progressing well as pipeline advances
News | January 15, 2025

Bayer’s pharma growth strategy progressing well as pipeline advances

Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid


Glenmark USA launches Lacosamide Oral Solution, 10 mg/mL
News | December 17, 2024

Glenmark USA launches Lacosamide Oral Solution, 10 mg/mL

According to IQVIATM sales data for the 12-month period ending October 2024, the Vimpat Oral Solution, 10 mg/mL market achieved annual sales of approximately $57.0 million


Lupin receives tentative approval from USFDA for Abacavir, Dolutegravir and Lamivudine tablets for oral suspension
Drug Approval | December 09, 2024

Lupin receives tentative approval from USFDA for Abacavir, Dolutegravir and Lamivudine tablets for oral suspension

The fixed-dose combination of Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen


FDA RMAT status for Affimed and Artiva’s lymphoma combo therapy
Drug Approval | December 07, 2024

FDA RMAT status for Affimed and Artiva’s lymphoma combo therapy

Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients


FDA accepts supplemental Biologics License Application for Roche’s Columvi combination
Drug Approval | December 06, 2024

FDA accepts supplemental Biologics License Application for Roche’s Columvi combination

For people with relapsed or refractory diffuse large B-cell lymphoma


Lupin gets tentative approval from USFDA for Sitagliptin and Metformin Hydrochloride Tablets
Drug Approval | December 05, 2024

Lupin gets tentative approval from USFDA for Sitagliptin and Metformin Hydrochloride Tablets

Sitagliptin and Metformin Hydrochloride Tablets, 50 mg/500 mg and 50 mg/1000 mg are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus