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Ocugen, Inc. Announces U.S. FDA Submission of Investigational New Drug Application
Monday, February 27, 2023Ocugen announced that it has submitted an Investigational New Drug application IND with the US Food and Drug Administration FDA to initiate a Phase clinical trial of OCU a fusion protein with a distinct mechanism of action MOA for the treatment of d...
FDA Approves Once-Weekly ALTUVIIIO™, a New Class of Factor VIII Therapy
Thursday, February 23, 2023The US Food and Drug Administration FDA has approved ALTUVIIIO Antihemophilic Factor Recombinant FcVWFXTEN Fusion Proteinehtl previously referred to as efanesoctocog alfa a firstinclass highsustained factor VIII replacement therapy ALTUVIIIO is indic...
AstraZeneca Enters Licence Agreement with KYM Biosciences
Thursday, February 23, 2023AstraZeneca and KYM Biosciences have entered into a global exclusive licence agreement for CMG a potential firstinclass antibody drug conjugate ADC targeting Claudin a promising therapeutic target in gastric cancer Under the licence agreement AstraZ...
BioAtla Announces FDA Clearance of Investigational New Drug Application for BA3182
Thursday, February 23, 2023BioAtla announced that the US Food and Drug Administration FDA has cleared the investigational new drug IND application to evaluate BA CABEpCAMxCABCD bispecific Tcell engager for the treatment of advanced adenocarcinoma BioAtla plans to initiate and...
Roche Launches Two New Antibodies to Identify Key Clinical Mutations
Thursday, February 23, 2023Roche announced the launch of the IDH RH MRQ Rabbit Monoclonal Primary Antibody and the ATRX Rabbit Polyclonal Antibody to identify mutation status in patients diagnosed with brain cancer The IDH RH and ATRX antibodies are the latest additions to Roc...
Calquence Tablet Formulation Receives Approval in European Union (EU)
Wednesday, February 22, 2023AstraZenecas tablet formulation of Calquence acalabrutinib has been approved in the European Union EU for the treatment of adult patients with chronic lymphocytic leukaemia CLL Calquence is approved as a capsule formulation for CLL in the EU It is al...
Moderna and Life Edit Therapeutics Enter Into Strategic Collaboration
Wednesday, February 22, 2023Moderna announced a strategic research and development collaboration to discover and develop in vivo mRNA gene editing therapies The partnership will combine Life Edits suite of proprietary gene editing technologies including base editing with Modern...
Pfizer’s Elranatamab Receives FDA and EMA Filing Acceptance
Wednesday, February 22, 2023Pfizer announced today that the US Food and Drug Administration FDA has granted priority review for the Biologics Licence Application BLA for elranatamab an investigational Bcell maturation antigen BCMA CDtargeted bispecific antibody BsAb for the tre...
Eterna Therapeutics Enters Into Licence Agreement with Lineage Cell Therapeutics
Wednesday, February 22, 2023Eterna Therapeutics announced that it has entered into an exclusive option and licence agreement the Agreement with Lineage Cell Therapeutics Lineage for the development of novel induced hypoimmune pluripotent stem cell iPSC lines which Lineage will...
Pfizer Gets U.S. FDA Acceptance for Biologics Licence Application for its Respiratory Syncytial Virus Vaccine Candidate
Tuesday, February 21, 2023Pfizer announced that the US Food and Drug Administration FDA has accepted for review a Biologics Licence Application BLA for its respiratory syncytial virus RSV vaccine candidate PF or RSVpreF for the prevention of medically attended lower respirato...
