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3044 News Found

Zydus receives final and tentative approval from USFDA for Tofacitinib Tablets
Drug Approval | March 22, 2023

Zydus receives final and tentative approval from USFDA for Tofacitinib Tablets

Tofacitinib Tablets, 5 mg and 10 mg had annual sales of US $900 million in the United States (IQVIA MAT December 2022)


Granules Consumer Health concludes FDA audit with zero observations
Drug Approval | March 22, 2023

Granules Consumer Health concludes FDA audit with zero observations

The audit is a pre-approval inspection for three products filed from the facility


Lupin receives approval from USFDA for Brexpiprazole Tablets
Drug Approval | March 22, 2023

Lupin receives approval from USFDA for Brexpiprazole Tablets

Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, (RLD Rexulti) had estimated annual sales of US $1,575 million in the US (IQVIA MAT December 2022)


Glenmark receives ANDA approval for Prochlorperazine Maleate Tablets
Drug Approval | March 21, 2023

Glenmark receives ANDA approval for Prochlorperazine Maleate Tablets

According to IQVIA sales data for the 12-month period ending January 2023, the Compazine Tablets, 5 mg and 10 mg market achieved annual sales of approximately US $26.9 million


Caplin receives USFDA approval for Rocuronium Bromide Injection
Drug Approval | March 21, 2023

Caplin receives USFDA approval for Rocuronium Bromide Injection

Rocuronium Bromide Injection had an annual sale of approximately US $53 million in the US (IQVIA MAT December 2022)


Patritumab Deruxtecan shows better clinical activity in patient with lung and breast cancer
Diagnostic Center | March 20, 2023

Patritumab Deruxtecan shows better clinical activity in patient with lung and breast cancer

Subgroup analysis by HER2 expression from phase 1/2 trial of patients with HER3 expressing metastatic breast cancer highlighted in a second Presidential Session


Janssen announces novel dengue antiviral demonstrates efficacy in pre-clinical data
News | March 20, 2023

Janssen announces novel dengue antiviral demonstrates efficacy in pre-clinical data

The antiviral is efficacious in non-human primates, and is safe and well-tolerated in humans


Phase 3 data show Deuruxolitinib significantly improve scalp hair regrowth in Alopecia Areata
News | March 20, 2023

Phase 3 data show Deuruxolitinib significantly improve scalp hair regrowth in Alopecia Areata

The Phase 3 data presented at AAD include a comprehensive review of the THRIVE-AA2 results and further elaborate the topline data reported in August 2022


Bliss GVS Pharma gets 3 minor observations from USFDA for Palghar unit
Drug Approval | March 19, 2023

Bliss GVS Pharma gets 3 minor observations from USFDA for Palghar unit

The observations are procedural in nature


Briefs: Man Industries, Jeevan Scientific Technology, Unichem and Torrent Pharmaceuticals
Drug Approval | March 18, 2023

Briefs: Man Industries, Jeevan Scientific Technology, Unichem and Torrent Pharmaceuticals

Man Industries (India) Limited has received a new export order of approximately Rs. 1,300 crores.