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Results For "US-FDA"

451 News Found

Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19
Biotech | August 17, 2021

Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19

The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.


Granules clears US FDA audit
News | July 21, 2021

Granules clears US FDA audit

The US FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021


Girish Bhunje appointed Senior Vice President – API Operations at Intas Pharmaceuticals
People | June 25, 2026

Girish Bhunje appointed Senior Vice President – API Operations at Intas Pharmaceuticals

Intas Pharmaceuticals has appointed Girish Bhunje as Senior Vice President – API Operations


Shilpa Biologicals commissions Integrated ADC drug substance GMP manufacturing facility in Dharwad
Biopharma | June 25, 2026

Shilpa Biologicals commissions Integrated ADC drug substance GMP manufacturing facility in Dharwad

This makes the company among few in India to offer fully integrated, end-to-end ADC drug substance development and manufacturing, encompassing payload synthesis, linker development and manufacturing


Shilpa Biologicals commissions rare integrated ADC manufacturing facility in India
News | June 24, 2026

Shilpa Biologicals commissions rare integrated ADC manufacturing facility in India

With this commissioning, Shilpa Medicare joins a very small group of Indian companies capable of offering end-to-end ADC Drug Substance development and manufacturing


Teva submits FDA application for experimental Tourette syndrome treatment ecopipam
Drug Approval | June 23, 2026

Teva submits FDA application for experimental Tourette syndrome treatment ecopipam

The filing is backed by positive Phase 3 results recently published in JAMA Neurology


FDA clears 131 drugs as global pharma approval momentum rebounds in 2025
News | June 23, 2026

FDA clears 131 drugs as global pharma approval momentum rebounds in 2025

After a volatile decade in which approvals swung sharply from year to year, 2025’s total pushed past long-term norms, exceeding the 10-year average


Roche’s Lunsumio VELO–Polivy combo moves closer to FDA decision after strong lymphoma trial results
News | June 23, 2026

Roche’s Lunsumio VELO–Polivy combo moves closer to FDA decision after strong lymphoma trial results

The safety profile of the Lunsumio and Polivy combination was consistent with the known profiles of the individual study medicines


FDA fast-tracks Roche cancer drug filing after landmark trial shows 50% recurrence reduction
Drug Approval | June 23, 2026

FDA fast-tracks Roche cancer drug filing after landmark trial shows 50% recurrence reduction

The FDA has granted Priority Review, setting a target decision date of 9 October 2026, potentially accelerating access to a new treatment option for a subset of patients with high-risk colon cancer characterized


India is becoming centre of innovation and global execution: Sanjay Vyas, President and MD, Parexel India
interviews | June 22, 2026

India is becoming centre of innovation and global execution: Sanjay Vyas, President and MD, Parexel India

Country’s deep scientific talent pool and its growing role as a clinical trial destination makes it central to how Parexel serves sponsors