Ultomiris showed early effect and lasting improvement in activities of daily living and has potential to reduce treatment burden with dosing every 8 weeks
Enhertu has now been granted five Breakthrough Therapy Designations, including three in breast cancer and one in both lung and gastric cancers
Diana is a senior leader with more than 38 years of field experience in U.S. FDA’s Office of Regulatory Affairs (ORA)
Desidustat is currently approved only in India as OxemiaTM for patients with CKD induced anemia
The tablets are available in 100 mg strength in bottle count sizes of 60
Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022
The company also plans to expand the facility
The association has lined up a string of prominent speakers from the government and private sector. Seasoned veterans and industry bigwigs will grace the two-day event in Mumbai
This product is indicated for the short-term treatment of a breathing problem (apnea) in premature infants
If authorized by the USFDA, the Proof Lab Test System may be used to deliver accurate, actionable, lab-quality results for Covid-19 in as little as 18 minutes
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