IPP Bureau

Glenmark Pharmaceuticals USA to launch Leucovorin Calcium for Injection USP, 350 mg/vial single-dose vial
Glenmark Pharmaceuticals USA to launch Leucovorin Calcium for Injection USP, 350 mg/vial single-dose vial

By IPP Bureau - December 12, 2025

Glenmark's Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial is bioequivalent and therapeutically equivalent to the reference listed drug

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

By IPP Bureau - December 12, 2025

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

By IPP Bureau - December 12, 2025

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

GSK’s experimental lung cancer drug gains FDA orphan drug status
GSK’s experimental lung cancer drug gains FDA orphan drug status

By IPP Bureau - December 12, 2025

GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization

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

By IPP Bureau - December 12, 2025

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

Pfizer’s TUKYSA shows major benefit in first-line maintenance for metastatic breast cancer
Pfizer’s TUKYSA shows major benefit in first-line maintenance for metastatic breast cancer

By IPP Bureau - December 12, 2025

The Phase 3 HER2CLIMB-05 trial showed a 35.9% reduction in risk for patients treated with TUKYSA

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

By IPP Bureau - December 12, 2025

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

Teva files FDA application for once-monthly schizophrenia injection
Teva files FDA application for once-monthly schizophrenia injection

By IPP Bureau - December 11, 2025

The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time

Lilly drug cuts risk of disease progression or death by 80% in trial
Lilly drug cuts risk of disease progression or death by 80% in trial

By IPP Bureau - December 11, 2025

The company has unveiled the results of pirtobrutinib from its BRUIN CLL-313 study

BioNTech and Bristol Myers Squibb report punchy early results for experimental TNBC therapy
BioNTech and Bristol Myers Squibb report punchy early results for experimental TNBC therapy

By IPP Bureau - December 11, 2025

The Phase 2 study tested two dose levels of pumitamig alongside four standard chemotherapy regimens across first

Roche secures CE mark for groundbreaking Vaginitis test that promises accurate diagnosis
Roche secures CE mark for groundbreaking Vaginitis test that promises accurate diagnosis

By IPP Bureau - December 11, 2025

Roche says its new assay “resolves this challenge by delivering accurate and specific results

Roche secures European nod for Gazyva/Gazyvaro in Lupus Nephritis patients
Roche secures European nod for Gazyva/Gazyvaro in Lupus Nephritis patients

By IPP Bureau - December 11, 2025

The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies

Bristol Myers Squibb unveils breakthrough Lymphoma data
Bristol Myers Squibb unveils breakthrough Lymphoma data

By IPP Bureau - December 11, 2025

Golcadomide, a CELMoD agent, continued to deliver deep and durable responses in aggressive B-cell and follicular lymphomas

Novo Nordisk completes acquisition of Akero Therapeutics
Novo Nordisk completes acquisition of Akero Therapeutics

By IPP Bureau - December 10, 2025

Akero became a wholly owned subsidiary of Novo Nordisk

Croda strikes strategic deal with Amino to boost global supply of high-purity amino acids
Croda strikes strategic deal with Amino to boost global supply of high-purity amino acids

By IPP Bureau - December 10, 2025

The agreement pairs Croda’s global footprint and “smart science” approach with Amino’s precision manufacturing capabilities

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