Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 22

Results For "PLI"

3330 News Found

FDA completes inspection of SMS Pharma’s Vizag facility
Drug Approval | December 14, 2025

FDA completes inspection of SMS Pharma’s Vizag facility

The inspection concluded with one minor observation in Form 483


Lupin Manufacturing Solutions partners with PolyPeptide to scale global peptide supply chain
News | December 12, 2025

Lupin Manufacturing Solutions partners with PolyPeptide to scale global peptide supply chain

This partnership strengthens LMS as a leading CDMO supplier of peptide materials for both innovator and generic markets


Granules Life Sciences facility receives EIR from USFDA
News | December 12, 2025

Granules Life Sciences facility receives EIR from USFDA

This approval confirms the facility's compliance with FDA quality standards and regulatory requirements


Suven Life Sciences achieved 100% patient enrolment in Phase-2b clinical trial of Ropanicant for MDO
Clinical Trials | December 12, 2025

Suven Life Sciences achieved 100% patient enrolment in Phase-2b clinical trial of Ropanicant for MDO

The Phase-2b study is a randomized, double-blind, placebo-controlled trial that will enroll approximately 195 patients across 35 sites in the USA


Alembic receives USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic suspension
News | December 12, 2025

Alembic receives USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic suspension

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb


FDA fast-tracks first drug nod under new national priority voucher program
News | December 12, 2025

FDA fast-tracks first drug nod under new national priority voucher program

The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals


Neurizon’s ALS drug regimen cleared for launch in Healey platform trial
Clinical Trials | December 12, 2025

Neurizon’s ALS drug regimen cleared for launch in Healey platform trial

The Healey ALS Platform Trial is a multicenter, double-blind, placebo-controlled


Bristol Myers Squibb scores FDA priority review for Opdivo in advanced hodgkin lymphoma
Drug Approval | December 12, 2025

Bristol Myers Squibb scores FDA priority review for Opdivo in advanced hodgkin lymphoma

The FDA aims to make a decision by April 8, 2026


Eli Lilly’s retatrutide delivers breakthrough results in obesity & knee osteoarthritis trial
Clinical Trials | December 12, 2025

Eli Lilly’s retatrutide delivers breakthrough results in obesity & knee osteoarthritis trial

Retatrutide, tested at 9 mg and 12 mg doses alongside diet and exercise, met all primary and key secondary endpoints