Johnson & Johnson has submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) to extend the use of the human interleukin (IL)-12 and IL-23 antagonist, Stelara (ustekinumab), for paediatric patients aged two and above with moderately to severely active Crohn's disease (CD).
Zealand Pharma has made a marketing authorisation application (MAA) submission to the European Medicines Agency (EMA) for its long-acting GLP-2 analogue, glepaglutide, to treat adults with short bowel syndrome (SBS).
Bio-Thera Solutions has entered into a partnership with Astra Industrial Group subsidiary, Tabuk Pharmaceutical Manufacturing Company, to bring BAT2206, Jansen's Stelara (ustekinumab) biosimilar, to the Saudi Arabian market.
The Department of Health of the Hong Kong Special Administrative Region, China, has accepted the new drug application (NDA) for oral VELSIPITY (etrasimod) submitted by Everest Medicines, for treating adults with moderately to severely active ulcerative colitis (UC).
Johnson & Johnson has filed a supplemental biologics license application (sBLA) with the US Food and Drug Administration (FDA) seeking approval for TREMFYA (guselkumab)to treat moderately to severely active ulcerative colitis (UC).
GENESIS Pharma has entered into an exclusive distribution agreement with Deciphera Pharmaceuticals for the marketing of Ripretinib in 14 European Union (EU) markets in Central and Eastern Europe.
Alfasigma has entered into an agreement to take over the Jyseleca (filgotinib) business of Galapagos.
Biopharmaceutical company Palisade Bio has received a milestone payment from the US Crohn's and Colitis Foundation for the development of its lead programme, PALI-2108.
Biopharmaceutical company Everest Medicines has received approval from China’s National Medical Products Administration (NMPA) for its new drug application (NDA) related to Xerava (eravacycline) to treat complicated intra-abdominal infections (cIAI) in adults.
Statera Biopharma has announced its intent to enter into a non-binding term sheet with regard to a strategic partnership with Lay Sciences, a development and commercialisation company of innovative solutions to license global manufacturing rights to some of Lay Sciences’ IgY products featuring avian antibodies as an active ingredient.
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