Browsing Tag
EMA
28 posts
FDA acceptance of Sarfaraz Niazi’s biosimilar petition could reset the economics of monoclonal antibody approvals
FDA accepts Sarfaraz Niazi’s petition to waive costly clinical efficacy studies for monoclonal antibody biosimilars, reshaping drug affordability worldwide.
WuXi Biologics wins EMA approval in Ireland as WuXiUP automation signals new chapter in global biologics manufacturing
WuXi Biologics secures EMA approval in Ireland and achieves WuXiUP automated continuous production, reinforcing global dual sourcing and biomanufacturing innovation.
Biocon (NSE: BIOCON) gains EU nod for Denosumab biosimilars Vevzuo and Evfraxy to target bone health market
Biocon Biologics receives EU approval for Denosumab biosimilars Vevzuo and Evfraxy. Find out how this milestone could reshape its European biosimilars strategy.
Omeros seeks EMA approval for narsoplimab to treat stem cell transplant-related TA-TMA
Omeros Corporation has submitted a Marketing Authorization Application to the EMA for narsoplimab, aiming to treat TA-TMA across Europe. Learn what’s at stake.
Sun Pharmaceutical faces regulatory pause as EMA application for melanoma drug withdrawn
Sun Pharmaceutical’s EU partner Philogen has withdrawn its EMA application for Nidlegy, delaying regulatory progress in melanoma care. Read what’s next.
Will CABOMETYX secure EU approval for advanced neuroendocrine tumors after CHMP’s positive opinion?
Ipsen’s CABOMETYX receives EMA's CHMP backing for advanced neuroendocrine tumors; EU approval expected in 2025 following FDA nod.
Lupin to launch India’s first green inhalers with Honeywell’s Solstice Air: Can pharma go climate-smart?
Lupin is partnering with Honeywell to launch India’s first low-GWP inhalers using Solstice Air propellant. Find out how it’s reshaping respiratory care.
Biocon Biologics reports positive Phase 3 results for Yesintek, biosimilar to Ustekinumab
Biocon Biologics Ltd., a global leader in biosimilar medicines and a subsidiary of India’s pioneering biopharmaceutical giant Biocon…
Vertex Pharmaceuticals bags UK approval for ALYFTREK, a next-generation cystic fibrosis treatment
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for ALYFTREK (deutivacaftor/tezacaftor/vanzacaftor), a next-generation…
EC approves CSL and Arcturus Therapeutics’ KOSTAIVE mRNA COVID-19 vaccine
The European Commission (EC) has officially granted COVID-19 vaccine approval for KOSTAIVE, the first self-amplifying mRNA vaccine for…