News | 13 December 2025
EMA backs Eylea 8 mg for retinal vein occlusion
The positive CHMP opinion is supported by results from the Phase III QUASAR trial
The positive CHMP opinion is supported by results from the Phase III QUASAR trial
WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states
Glenmark's Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial is bioequivalent and therapeutically equivalent to the reference listed drug
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals
The cobas Mass Spec solution Ionify reagent portfolio now covers therapeutic drug monitoring for immunosuppressants and antibiotics
The U.S. oncology market is projected to soar from $81 billion in 2025 to $212 billion by 2034
LNK01006 is designed to deliver potent, selective inhibition of TYK2-mediated cytokine signaling with central nervous system exposure
This partnership strengthens LMS as a leading CDMO supplier of peptide materials for both innovator and generic markets
This is the first approval of a prescription transdermal dosage Form in the European markets from this facility
The product will be marketed by Dr. Reddy's Laboratories Inc.
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
Roche says its new assay “resolves this challenge by delivering accurate and specific results
Golcadomide, a CELMoD agent, continued to deliver deep and durable responses in aggressive B-cell and follicular lymphomas
Akero became a wholly owned subsidiary of Novo Nordisk
The new site will produce next-generation synthetic medicine active pharmaceutical ingredients
Zyrifa is indicated for patients with bone metastases stemming from a wide range of solid tumors
Formycon AG will develop, register, manufacture and supply the product, while Zydus Lifesciences Global FZE, United Arab Emirates will be responsible for the commercialization of FYB206 in the defined territories
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Tirzepatide is the first and only dual agonist glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors
Dr Reddy’s will pay Immutep US$ 20 million upfront and could deliver as much as US$ 349.5 million in regulatory and commercial milestones
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