IPP Bureau
Lilly drug cuts risk of cancer progression, extends survival in advanced breast cancer trial
By IPP Bureau - December 13, 2025
Updated results from the EMBER-3 study showed that the drug -- Inluriyo (imlunestrant) -- as a standalone treatment cut the risk of progression or death by 38%
EMA backs higher-dose Wegovy, clearing path for greater weight loss option in Europe
By IPP Bureau - December 13, 2025
EMA backs Eylea 8 mg for retinal vein occlusion
By IPP Bureau - December 13, 2025
The positive CHMP opinion is supported by results from the Phase III QUASAR trial
Merck wins key EU backing to expand use of PAH Drug WINREVAIR
By IPP Bureau - December 13, 2025
WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states
UPM unveils world’s first carbon-negative, fully recyclable black pigment
By IPP Bureau - December 13, 2025
The innovation -- UPM Circular Renewable Black -- is the world’s first bio-based, near-infrared (NIR) detectable, carbon-negative black
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
$22 million BARDA project taps ProteoNic Tech to boost life-saving monoclonal antibody manufacturing
By IPP Bureau - December 12, 2025
The multi-partner team will integrate new technologies across the entire mAb production workflow, from cell line development to purification
Bristol Myers Squibb scores FDA priority review for Opdivo in advanced hodgkin lymphoma
By IPP Bureau - December 12, 2025
The FDA aims to make a decision by April 8, 2026
Eli Lilly’s retatrutide delivers breakthrough results in obesity & knee osteoarthritis trial
By IPP Bureau - December 12, 2025
Retatrutide, tested at 9 mg and 12 mg doses alongside diet and exercise, met all primary and key secondary endpoints
