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Centessa Pharmaceuticals Receives U.S. FDA Fast Track Designation for SerpinPC Hemophilia B
Monday, May 22, 2023Centessa Pharmaceuticals announced that the US Food and Drug Administration FDA has granted Fast Track designation to SerpinPC an investigational novel inhibitor of activated protein C APC being developed for the treatment of hemophilia B with or wit...
Ironwood Pharmaceuticals Enters into Agreement to Acquire VectivBio
Monday, May 22, 2023Ironwood Pharmaceuticals and VectivBio Holding announced that they have entered into a definitive agreement for Ironwood to acquire VectivBio for per share in an allcash transaction with an estimated aggregate consideration of approximately billion...
Sangamo Therapeutics Receives U.S. FDA Fast Track Designation for Isaralgagene Civaparvovec
Monday, May 22, 2023Sangamo Therapeutics announced that the US Food and Drug Administration FDA has granted Fast Track Designation to isaralgagene civaparvovec or ST a wholly owned gene therapy product candidate for the treatment of Fabry disease
Blueprint Medicines Announces U.S. FDA Approval of AYVAKIT® (avapritinib)
Monday, May 22, 2023Blueprint Medicines announced that the US Food and Drug Administration FDA has approved AYVAKIT avapritinib for the treatment of adults with indolent systemic mastocytosis ISM
Krystal Biotech Receives FDA Approval for VYJUVEK™ (beremagene geperpavec-svdt)
Saturday, May 20, 2023Krystal Biotech announced the US Food and Drug Administration FDA has approved VYJUVEK beremagene geperpavecsvdt for the treatment of patients six months of age or older with dystrophic epidermolysis bullosa DEB
Galera Therapeutics Announces FDA Orphan Drug Designation for Rucosopasem
Friday, May 19, 2023Galera Therapeutics announced that the US Food and Drug Administration FDA has granted orphan drug designation to Galeras second product candidate rucosopasem manganese rucosopasem for the treatment of pancreatic cancer
AbbVie Announces U.S. FDA Approval of EPKINLY™ (epcoritamab-bysp)
Friday, May 19, 2023AbbVie announced that the US Food and Drug Administration FDA has approved EPKINLYTM epcoritamabbysp as the first and only bispecific antibody to treat adult patients with relapsed or refractory diffuse large Bcell lymphoma DLBCL
Rznomics Received FDA Approval to Initiate Clinical Development of Trans-splicing ribozyme-based RNA Editing Technology
Friday, May 19, 2023Rznomics received Phase a IND approval from the US FDA for its Glioblastoma Multiforme GBM treatment called RZ
Antengene Announces Clearance of U.S. IND for the Phase I Trial
Thursday, May 18, 2023Antengene Corporation announced that the Investigational New Drug IND for a Phase I study of the firstinclass antiCD monoclonal antibody ATG has received clearance from the US Food and Drug Administration FDA
Revvity Announces New Licence Agreement with AstraZeneca
Thursday, May 18, 2023Revvity announced a new licence agreement with AstraZeneca for the technology underlying its Pinpoint base editing system a nextgeneration modular gene editing platform with a strong safety profile