April 18th 2024Article
Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Social value of statins merits actions to broaden treatment, improve adherence, study finds
New evidence suggests that statins generate large survival and health benefits at the population level and shows that the social value of the survival gains are large and go predominantly to consumers, according to a study published in the October issue of Health Affairs.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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Par Recalls More Treprostinil Due to Silicone in the Product
April 22nd 2024An additional seven lots of Treprostinil are affected on top of last month’s recall of one lot.
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FDA Approves Pen Form of Entyvio for Crohn’s Disease
April 19th 2024Entyvio as an injection and subcutaneous formulations is approved to treat both Crohn’s and ulcerative colitis.
Read More
FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Read More
Most Cancer Drugs With Accelerated Approval Don’t Show Benefit
April 18th 2024Researchers were unable to find a significant benefit for patients for the majority of cancer medications given accelerated FDA approval.
Read More
FDA Approves GSK's BLA for 5-in-1 Meningococcal Vaccine
April 17th 2024The vaccine combines the antigenic components of its two meningococcal vaccines: Bexsero and Menveo. The action date is Feb. 14, 2025.
Read More
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
Read More
Par Recalls More Treprostinil Due to Silicone in the Product
April 22nd 2024An additional seven lots of Treprostinil are affected on top of last month’s recall of one lot.
Read More
FDA Approves Pen Form of Entyvio for Crohn’s Disease
April 19th 2024Entyvio as an injection and subcutaneous formulations is approved to treat both Crohn’s and ulcerative colitis.
Read More
FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Read More
Most Cancer Drugs With Accelerated Approval Don’t Show Benefit
April 18th 2024Researchers were unable to find a significant benefit for patients for the majority of cancer medications given accelerated FDA approval.
Read More
FDA Approves GSK's BLA for 5-in-1 Meningococcal Vaccine
April 17th 2024The vaccine combines the antigenic components of its two meningococcal vaccines: Bexsero and Menveo. The action date is Feb. 14, 2025.
Read More