This clearance allows the company to initiate a clinical trial for patients with an ileal pouch-anal anastomosis
The company will engage with the agency to resolve the import alert at the earliest.
Granules now have a total of 53 ANDA approvals from USFDA
The product will be manufactured at the plant of Bell, Sons & Co. (Druggists) Ltd. located at Gifford House, Slaidburn Crescent, Southport, UK
Two biopharmaceutical experts join SK bioscience to strengthen the future strategies
Products offered on a not-for-profit basis to the 45 lower-income countries now include the full portfolio for which Pfizer has global rights.
Following successful completion of full set of clinical studies of proposed rituximab biosimilar candidate DRL_RI, Dr. Reddy’s will now prepare to file in the United States, European Union and other regions
The AGE1.CR.pIX cell line is derived from primary cells of a duck embryo and was designed to comply with health authority guidelines
Through the new agreements, Cristal Therapeutics and McSAF will gain access to Lonza’s integrated bioconjugates offering and will be able to leverage Lonza’s expertise in developing and manufacturing bioconjugates
New facility is based at Lonza’s Bend, Oregon (US) site, a Center of Excellence for bioavailability enhancement
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