IPP Bureau
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
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
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
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
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
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
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
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
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
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
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
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
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
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
By IPP Bureau - December 10, 2025
The agreement pairs Croda’s global footprint and “smart science” approach with Amino’s precision manufacturing capabilities
