Pfizer scores landmark EU approval for hemophilia drug HYMPAVZI
The decision marks a significant expansion for Pfizer’s once-weekly injectable therapy
The decision marks a significant expansion for Pfizer’s once-weekly injectable therapy
The company also confirmed that ABS-1230 has been accepted into the U.S. Food and Drug Administration’s Rare Disease Evidence Principles (RDEP) process
The once-daily oral therapy is the first and only tyrosine kinase 2 (TYK2) inhibitor approved in the European Union for this indication, marking a significant expansion of its immunology portfolio
At the center of the deal is TERN-701, a drug recently granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for adults with Philadelphia chromosome-positive chronic myeloid leukemia
The proposed biosimilar to Keytruda demonstrated pharmacokinetic bioequivalence in a multicountry Phase 1 study involving non-small cell lung cancer patients
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3 to 6 against recommending camizestrant in combination with a CDK4/6 inhibitor
Notice of Compliance from Health Canada enables marketing authorisation for cancer biosimilar in Canadian market
The trials -- ELOWEN-1 and ELOWEN-2 -- are designed to evaluate the drug in people living with lupus who experience active skin manifestations
Our company remains focused on advancing monoclonal antibody therapeutics for solid tumors, with a clear emphasis on combination immunotherapy strategies
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