Browsing Tag
FDA
341 posts
Is Orencia finally vulnerable? Dr. Reddy’s abatacept biosimilar clears a key FDA hurdle
Dr. Reddy’s abatacept biosimilar enters FDA review. See what this means for Orencia, biosimilar policy, and U.S. autoimmune drug pricing.
Aurobindo Pharma (NSE: AUROPHARMA) shares slide after FDA flags compliance gaps at Telangana unit
Aurobindo Pharma shares fell after the US FDA flagged nine issues at a Telangana plant. Find out what it means for compliance, investors, and the stock outlook.
Is co-administered COVID prophylaxis with antibodies and mRNA vaccines the next FDA-backed model?
Invivyd’s LIBERTY trial explores co-administered COVID prevention with VYD2311 and mRNA vaccines. See how this could influence FDA and payer strategies.
Frontage Laboratories adds oncology and radiolabeled capacity to Secaucus Phase I unit for integrated CRDMO execution
Frontage Laboratories expands early-phase clinical research in U.S. and China. Find out how its oncology and AME focus could reshape sponsor strategies.
Zelira Therapeutics (ASX:ZLD) secures $33m to advance HOPE 1 autism therapy through U.S. FDA trials
Find out how Zelira’s US$33M SPV deal with ThirdGate Capital is reshaping its FDA strategy for HOPE 1 and shaking up the autism biotech space.
FDA clears mAbxience and Amneal’s denosumab biosimilars: What it means for the bone health and oncology market
Find out how Amneal and mAbxience’s FDA-approved biosimilars to Prolia and XGEVA could reshape the bone health and cancer care markets in the U.S.
Intellidrop gets FDA clearance: BrainSpace aims to fix ICU neuro workflows and train Physical AI models
Find out how BrainSpace’s FDA-cleared Intellidrop system could automate ICU brain care and power the next generation of Physical AI.
Vanda Pharmaceuticals (NASDAQ: VNDA) wins long-awaited FDA approval for NEREUS, first new motion sickness drug in 40+ years
Find out how Vanda Pharmaceuticals’ FDA-approved NEREUS (tradipitant) is redefining motion sickness treatment after 40 years of stagnation. Read the full story now.
Mabwell’s anti-ST2 antibody enters U.S. trials: Can 9MW1911 reshape immunotherapy for COPD?
Mabwell’s anti-ST2 antibody 9MW1911 enters U.S. trials after strong COPD data in China. Find out what this could mean for immunotherapy's future in COPD.
Hansa Biopharma targets Q3 2026 approval for imlifidase with Priority Review request
Hansa Biopharma submits imlifidase BLA to the FDA, aiming to transform access to kidney transplants for highly sensitized patients. Read more on what’s next.