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Lupin Receives U.S. FDA Approval for Ranluspec™ (ranibizumab) Injection: Interchangeable Biosimilar for Eye Diseases Now Cleared in the U.S.

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Lupin Limited has received approval from the U.S. FDA for Ranluspec™ (ranibizumab-hkdz), an interchangeable biosimilar referencing Lucentis® (Genentech). Approval granted on June 4, 2026 . Ranluspec is the only interchangeable biosimilar ranibizumab currently approved in the United States, and is available in both vials and pre‑filled syringes (PFS) . Approved strengths are 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL) , matching those of Lucentis. - The product is indicated for treatment of: Neovascular (wet) age‑related macular degeneration (AMD) Macular edema following retinal vein occlusion (RVO) Diabetic macular edema (DME) Diabetic retinopathy (DR) Myopic choroidal neovascularization (mCNV) Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that inhibits vascular endothelial growth factor A (VEGF‑A) to reduce abnormal blood vessel growth and leakage in the retina. Lupin highlighted this approval as a strategic milestone th...

Supreme Court sides with Hikma in 'skinny label' case

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Acting FDA chief isn't interested in permanent role: Key facts Kyle Diamantas, an attorney who previously led the FDA's food program, has been named acting commissioner of the Food and Drug Administration following the resignation of Commissioner Marty Makary. Diamantas is stepping in on an interim basis while the administration searches for a permanent replacement, who will need to be nominated by the President and confirmed by the Senate. Reports indicate that Diamantas is viewed as a steady hand to manage the agency through this transition. There is no indication that Diamantas is seeking the permanent role, suggesting that he is not interested in becoming the next permanent FDA commissioner.

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Medline Faces FDA Warning Over Repeat *Bacillus cereus* Contamination in Drug Products

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Alnylam and Inceptive Form Strategic AI Collaboration to Accelerate the Discovery of RNAi Therapeutics

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Parabilis preps $413M IPO to fuel desmoid tumor drug into phase 3

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ADC Therapeutics shares sink over 50% after Phase 3 Zynlonta trial shows more deaths than standard therapy

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As China biotech crackdown calls reverberate in Washington, the pushback gets louder, too Recent efforts in Washington to restrict U.S. investment and partnerships with Chinese biotech firms have triggered a fierce backlash from industry leaders and intensified concerns in Beijing, turning biotech into the latest front in the U.S.-China tech rivalry.

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AbbVie’s QULIPTA and Amgen’s Imdylltra Score New EU Approvals for Migraine and Lung Cancer Indications

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Real-world patterns of Alzheimer’s disease biomarker testing: Insights from a large-scale clinical dataset (Overview, 2026)

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Germany’s Health‑Spending Cuts Prompt Lilly and Boehringer to Scale Back German Investments

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Regeneron doubles down on CytomX despite other pharma exits, expanding pact to up to ~$4 billion potential value

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ChatGPT and other LLMs for cancer patient education: help or hindrance?

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