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US FDA Granted Orphan Drug Designation for Benlysta
Thursday, February 02, 2023GSK announced that the US Food and Drug Administration FDA has granted Orphan Drug Designation ODD to Benlysta belimumab a Bcell inhibiting monoclonal antibody for the potential treatment of systemic sclerosis GSK plans to initiate a phase IIIII tria...
Cybin Announces Approval of First-in-Human Dosing of its Proprietary DMT Molecule CYB004
Thursday, February 02, 2023Cybin announced that it has received approval from an independent ethics committee in the Netherlands to initiate firstinhuman dosing of its proprietary deuterated NNdimethyltryptamine DMT molecule CYB through a protocol amendment to its ongoing CYBE...
Cidara Therapeutics and Wuxi XDC Expand Collaboration for IND-Enabling CMC Development
Thursday, February 02, 2023Cidara Therapeutics announced an expansion of their existing collaboration under which Wuxi XDC will provide investigational new drug indenabling chemistry manufacturing and controls CMC development services for cidaras CD oncology DFC programme
Jesduvroq (Daprodustat) Approved by US FDA for Anaemia of Chronic Kidney Disease
Thursday, February 02, 2023GSK today announced that the US Food and Drug Administration FDA has approved Jesduvroq daprodustat an oral hypoxiainducible factor prolyl hydroxylase inhibitor HIFPHI for the onceaday treatment of anaemia due to chronic kidney disease CKD in adults...
Fennec Pharmaceuticals Receives U.S. FDA Orphan Drug Exclusivity for Pedmark® (Sodium Thiosulfate Injection)
Wednesday, February 01, 2023Fennec Pharmaceuticals announced that the US Food and Drug Administration FDA has granted Orphan Drug Exclusivity to PEDMARK sodium thiosulfate injection indicated to reduce the risk of ototoxicity or hearing loss associated with cisplatin use in pae...
Ascletis Announces U.S. FDA Approval for Conducting a Phase IIa Clinical Trial
Wednesday, February 01, 2023Ascletis Pharma announced that the US Food and Drug Administration FDA has approved to conduct a Phase IIa clinical trial for ASC to treat respiratory syncytial virus RSV infection Based on available data dosage of mg ASC twice daily was selected to...
Hillstream BioPharma Signs Option Agreement to Advance Next-Generation Anti-MUC1-C Agents
Wednesday, February 01, 2023Hillstream BioPharma announced signing an exclusive option agreement with DanaFarber Cancer Institute to licence technology targeting the MUCC oncoprotein This agreement allows Hillstream to leverage Quatramer platform to advance antiMUCC agents targ...
Sun Pharma Acquires Disperzyme® And Phlogam® Brands
Tuesday, January 31, 2023Sun Pharmaceutical announced that it has acquired three brands viz Disperzyme Trypsin BP mg Bromelain mg Rutoside Trihydrate mg DisperzymeCD Trypsin BP mg Bromelain mg Rutoside Trihydrate mg and Phlogam Trypsin BP mg Bromelain mg Rutoside...
Charles River Completes Acquisition of SAMDI Tech
Tuesday, January 31, 2023Charles River announced the acquisition of SAMDI Tech The acquisition is the culmination of an exclusive partnership between the companies started in The acquisition of SAMDI Techs cuttingedge highthroughput screening technology further strengthens...
Xeris Biopharma Grants FDA Orphan-drug Exclusivity for Recorlev®
Tuesday, January 31, 2023Xeris Biopharma Holdings announced that the Food and Drug Administration FDA granted its subsidiary Xeris Pharmaceuticals orphandrug exclusivity ODE for Recorlev levoketoconazole for the treatment of adult patients with endogenous Cushings syndrome w...
