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
$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
Dr Agarwals Eye Hospital expands global footprint with advanced centre in Mauritius
By IPP Bureau - December 12, 2025
The new centre brings advanced corneal procedures pioneered in India
Roche bags CE Mark for automated mass spectrometry antibiotics monitoring
By IPP Bureau - December 12, 2025
The cobas Mass Spec solution Ionify reagent portfolio now covers therapeutic drug monitoring for immunosuppressants and antibiotics
FDA nods spotlight precision oncology platforms as market surges towards $212 billion by 2034
By IPP Bureau - December 12, 2025
The U.S. oncology market is projected to soar from $81 billion in 2025 to $212 billion by 2034
OTR Therapeutics and Zealand Pharma join forces to target metabolic diseases
By IPP Bureau - December 12, 2025
The companies aim to expand treatment options for millions living with metabolic disorders
Formation Bio snaps up global rights to next-gen CNS TYK2 inhibitor from Lynk Pharma
By IPP Bureau - December 12, 2025
LNK01006 is designed to deliver potent, selective inhibition of TYK2-mediated cytokine signaling with central nervous system exposure
