The FDA has accepted the resubmission of the BLA of Ordspono for review in relapsed/refractory follicular lymphoma following previous systemic therapy.

A new article in the journal Nucleic Acid Therapeutics addresses the recognition by the U.S. Food and Drug Administration ...

Four years after Sanofi shelled out $125 million for global rights to Biond Biologic | The company is handing back the tumor ...

Announced acceptance and Priority Review by the United States Food and Drug Administration (FDA) of the new drug application (NDA) for troriluzole in all-genotype spinocerebellar ataxia; expected ...

Tezepelumab (Tezspire) reduced nasal polyps and symptoms in severe chronic rhinosinusitis while also decreasing need for ...

Regeneron Pharmaceuticals (NASDAQ:REGN) said the European Medicines Agency’s Committee for Medicinal Products for Human Use ...

Outlook Therapeutics has re-submitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) ...

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human ...

Regeneron on Friday said the recommendation covers adults with adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, ...

The positive CHMP opinion is supported by data from the pivotal LINKER-MM1 trial, which evaluated linvoseltamab in adults with R/R MM. Earlier this month, the FDA accepted for review the Biologics ...

Pharmaceuticals announced that the European Medicines Agency’s, EMA, Committee for Medicinal Products for Human Use, CHMP, has ...