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Ogsiveo Receives FDA Approval as First Therapy for Desmoid Tumors

XTalks

Pfizer spinout SpringWorks Therapeutics’ Ogsiveo (nirogacestat) has received US Food and Drug Administration (FDA) approval for the treatment of desmoid tumors, an ultra-rare subtype of non-cancerous soft tissue sarcomas that can cause severe pain and disfigurement.

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Cyltezo Becomes First FDA-Approved Interchangeable Humira Biosimilar

XTalks

Boehringer Ingelheim’s Cyltezo has become the second interchangeable biosimilar approved by the FDA, and the first approved interchangeable monoclonal antibody. In July 2021, the agency approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn) for the treatment of diabetes.

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Brukinsa (zanubrutinib) Gets FDA Approval for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

XTalks

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. This includes a greater focus on digital campaigns and diversifying marketing campaigns with race and ethnicity insights.

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ImmunityBio’s Cancer Immunotherapy Anktiva Wins FDA Approval, Boasting a “Triangular Offense”

XTalks

ImmunityBio’s Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) along with the Bacillus Calmette-Guérin (BCG) vaccine has won US Food and Drug Administration (FDA) approval for the treatment of non-muscle invasive bladder cancer (NMIBC). The company is planning to launch Anktiva commercially in the US by mid-May.

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2021 Year in Review: Leveraging New Technologies to Drive Innovation in the Life Sciences

XTalks

Xtalks is taking a look at some of the major stories and innovations of the year in the life sciences, many of which were driven by new, emerging and improved technologies. The year 2021 was all about continuing innovations in the life sciences. Life Science Innovations: Malaria and Influenza Vaccines.

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Roche Reintroduces Susvimo Wet AMD Eye Implant After Recall

XTalks

Susvimo, a refillable eye implant, received US Food and Drug Administration (FDA) approval in 2021, but its initial rollout faced challenges due to septum dislodgement cases that prompted Roche to issue a voluntary market recall in October 2022. Merck is also looking to tread into the eye disease market.

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J&J’s Carvykti and BMS’ Abecma Win FDA Approvals for Earlier Use in Multiple Myeloma

XTalks

After backing from the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) last month, Johnson and Johnson (J&J) and Bristol Myers Squibb (BMS) scored FDA approvals for the use of their B-cell maturation antigen (BCMA)-targeting CAR T-cell therapies as earlier line treatment options for multiple myeloma.