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This latest FDA approval expands the blockbuster anti-cancer biologic’s indications in oncology.


Merck & Co.’s Keytruda Gets FDA Approval for Gastric Cancer

Glythera gains exclusive access to Cancer Research UK’s novel CDK11 inhibitor program for the development of ADCs conjugated using its highly stable conjugation platform, PermaLink.

Glythera Licenses Novel Payload Class from Cancer Research UK for ADC Development

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval. 

Will Interchangeability Boost Biosimilar Prescribing?

Ajinomoto Althea opens manufacturing suites in new high potency and antibody drug conjugate commercial facility.

Ajinomoto Althea Adds High Potency Capabilities

The collaboration with Immunocore, a T cell receptor company, aims to discover and develop immunotherapy molecules to treat infectious diseases.

Gates Foundation Invests $40 Million in Immunotherapy Collaboration

The approval marks the first biosimilar approved in the United States for treating cancers.

FDA Approves Amgen’s Avastin Biosimilar

European Medicines Agency’s Committee for Medicinal Products for Human Use grants a positive opinion for the approval of the biosimilar for treating breast cancer.

EMA Recommends Approval of Herceptin Biosimilar

The company has extended its presence in the US market to support its growing business in the region.

Oxford Genetics Opens First US Office

Merck KGaA completes the divestment of its biosimilars business as part of its strategy to focus on developing a pipeline of innovator drugs.

Merck KGaA Completes $788-Million Divestment of Biosimilars Business

Pfizer’s Mylotarg, an anti-body drug conjugate once voluntarily withdrawn, returns to the market under a new dosing regimen for treating leukemia.

Drug Substance Analysis