Browsing Tag
EMA
24 posts
Sun Pharmaceutical faces regulatory pause as EMA application for melanoma drug withdrawn
Sun Pharmaceutical’s EU partner Philogen has withdrawn its EMA application for Nidlegy, delaying regulatory progress in melanoma care.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…
Wockhardt’s Zaynich achieves record-breaking 96.8% clinical cure rate in cUTI Phase III trial
Wockhardt Limited has announced a major breakthrough in the treatment of complicated urinary tract infections (cUTI) with its…
FDA approves Pfizer’s HYMPAVZI for breakthrough hemophilia treatment
In a major leap for hemophilia patients, Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug…
Eton Pharmaceuticals shocks investors with major acquisition: Shares explode to 52-week high
Eton Pharmaceuticals has sent shockwaves through the pharmaceutical industry after its shares soared to a 52-week high, fueled…
Avanzanite Bioscience secures EC approval for AKANTIOR as first authorised treatment for acanthamoeba keratitis
The European Commission (EC) has granted marketing authorisation for AKANTIOR (polihexanide), the first and only approved treatment for…