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Teva’s AUSTEDO and AUSTEDO XR demonstrate real-world improvement in patients with tardive dyskinesia
Clinical Trials | November 11, 2025

Teva’s AUSTEDO and AUSTEDO XR demonstrate real-world improvement in patients with tardive dyskinesia

The results demonstrated meaningful reductions in the severity of involuntary movements and notable improvements in patient-reported quality of life


Gilead’s Trodelvy falls short on progression-free survival in key breast cancer trial
Clinical Trials | November 10, 2025

Gilead’s Trodelvy falls short on progression-free survival in key breast cancer trial

While the trial fell short of demonstrating a statistically significant PFS benefit compared to chemotherapy, early data suggest a potential overall survival advantage


Biohaven disappointed as rare disease therapy faces FDA setback 'despite promising results'
Drug Approval | November 10, 2025

Biohaven disappointed as rare disease therapy faces FDA setback 'despite promising results'

The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases


Novo Nordisk India partners with Emcure to commercialise Poviztra in India
News | November 10, 2025

Novo Nordisk India partners with Emcure to commercialise Poviztra in India

Poviztra is a second brand of Wegovy


Marksans Pharma's Goa unit clears FDA inspection
News | November 10, 2025

Marksans Pharma's Goa unit clears FDA inspection

The said inspection concluded with Zero Form 483 observation


Syngene International reports Q2 FY26 consolidated PAT at Rs. 67.1 Cr
News | November 09, 2025

Syngene International reports Q2 FY26 consolidated PAT at Rs. 67.1 Cr

Syngene International has reported total income of Rs. 926 crore during the period ended September 30, 2025


Lupin Bioresearch Center receives zero observations from USFDA
Drug Approval | November 08, 2025

Lupin Bioresearch Center receives zero observations from USFDA

A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations


Zydus receives FDA’s ODD for Desidustat for the treatment of beta-thalassemia
Drug Approval | November 06, 2025

Zydus receives FDA’s ODD for Desidustat for the treatment of beta-thalassemia

Orphan drug designation (ODD) by the USFDA for Desidustat, provides eligibility for a potential seven-year marketing exclusivity subject to the USFDA approval


Senores Pharma forms new subsidiary in US
News | November 06, 2025

Senores Pharma forms new subsidiary in US

Senores Pharmaceuticals (SPI) acquired 51% stake in Zoraya Pharmaceuticals