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FDA Grants Orphan Drug Status to Skyline Therapeutics’ Gene Therapy for Retinitis Pigmentosa
Wednesday, September 04, 2024Skyline Therapeutics made an announcement recently that the US FDA had accorded Orphan Drug Designation ODD to SKG a novel gene therapy developed to treat Retinitis Pigmentosa RP Orphan drug designation ODD is a status granted to promising drugs or b...
Innovent Biologics Receives Fast Track Designation for IBI363 in Melanoma Treatment
Wednesday, September 04, 2024Innovent Biologics has received fast track designation from the US Food and Drug Administration FDA for its PD ILbias bispecific antibody fusion protein IBI Developed by Innovent Biologics IBI is a bispecific antibody fusion protein that is PDILbias...
Simcere Zaiming Enters into Collaboration with TargetRx for Launching the Newest ALK Inhibitor
Tuesday, September 03, 2024Simcere Zaiming has partnered with TargetRx The partnership is on TGRX a dual ALKROS receptor tyrosine kinase inhibitor that is currently undergoing clinical trials TGRX is a thirdgeneration ALK inhibitor developed by TargetRx It is a highly selectiv...
NMPA Approves IND Application for Henlius' Pembrolizumab Biosimilar
Tuesday, September 03, 2024Shanghai Henlius Biotech has made an announcement indicating that their investigational new drug IND which is known as HLX and is a biosimilar version of pembrolizumab has been approved by the National Medical Products Administration NMPA
Chugai's PiaSky® Receives European Approval for Treatment of Paroxysmal Nocturnal Hemoglobinuria
Monday, September 02, 2024Chugai Pharmaceutical has announced that the European Commission has granted approval for PiaSky crovalimab a Chugaideveloped monoclonal antibody for the treatment of paroxysmal nocturnal hemoglobinuria PNH in adults and adolescents aged and over wh...
Jacobio Licenses Glecirasib and JAB-3312 to Allist for China Market
Saturday, August 31, 2024Jacobio Pharma has announced the transfer of rights for its KRAS GC inhibitor glecirasib and SHP inhibitor JAB to Shanghai Allist Pharmaceuticals for China including mainland China Hong Kong Macau and Taiwan Glecirasib developed by Jacobio is current...
Biocon Biologics Gains Approval to Launch Bmab 1200 in Europe, UK, Canada, and Japan
Friday, August 30, 2024Biocon Biologics announced today that it has signed a settlement and license agreement with Janssen Biotech Janssen Sciences and Johnson Johnson Stelara Ustekinumab is a monoclonal antibody used to treat conditions such as psoriasis Crohns disease u...
GSK Announces Expanded Indication of Arexvy for Lower Respiratory Tract Disease
Friday, August 30, 2024GSK has announced that the European Commission has authorised the use of Arexvy its respiratory syncytial virus RSV vaccine for adults aged who are at increased risk of lower respiratory tract disease LRTD caused by RSV
Chugai Pharmaceutical Announces Approval of Alecensa® in Japan
Thursday, August 29, 2024Chugai Pharmaceutical has secured approval for an additional indication of Alecensa alectinib its ALK inhibitor and antineoplastic agent for use as adjuvant therapy in ALK fusion genepositive nonsmall cell lung cancer NSCLC
Flagship Pioneering and Quotient Therapeutics Forge Agreement to Discover Novel Targets
Thursday, August 29, 2024Quotient Therapeutics and Pioneering Medicines Flagship Pioneerings internal drug development unit have embarked on a collaborative research initiative aimed at identifying somatic mutations in genes that influence the progression of cardiovascular a...
