Two biosimilars developed under the Teva - Alvotech partnership have been granted FDA approval with interchangeability, including SELARSDI. In February 2024, the FDA approved SIMLANDI® ...

Halozyme claims Merck infringed on patents in developing a subcutaneous form of Keytruda. Elsewhere, Vanda’s challenge to an ...

Two patients out of 299 in CLASSIC I developed antibodies to adalimumab. In CLASSIC II, 2.6% of patients had anti-adalimumab antibodies. These patients were not on other immunosuppression and the ...

Celltrion, Inc. announced that the US Food and Drug Administration (FDA) has designated Yuflyma (adalimumab-aaty), as an interchangeable ... human anti–tumour necrosis factor a (anti-TNFa) monoclonal ...

Vedolizumab is a humanized monoclonal antibody that selectively targets ... biologics—particularly anti-TNF agents such as infliximab or adalimumab—can be used alone or alongside ...

Adalimumab-aaty, the unbranded version ... YUFLYMA is a recombinant fully human anti–tumor necrosis factor α (anti-TNFα) monoclonal antibody. YUFLYMA is available in 20mg/0.2mL, 40mg/0.4mL and ...

The US Food and Drug Administration (FDA) has designated Yuflyma (adalimumab-aaty) as an interchangeable biosimilar ... subject to state laws All the news that moves the needle in pharma and biotech ...

The FDA is moving away from requiring animal models for investigational new drug (IND) applications for new monoclonal antibodies and ... Human Services told Fierce Biotech in an email.

While researchers discovered IgE antibodies all the way back in 1966, and biologics pioneers considered them at the birth of the biotech industry, Epsilogen claims its candidate is the world’s ...

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