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Key FDA approvals in pediatric health: First half of 2025
05 Jul 2025 13:34 GMT
… vaccination rates remain low.
The FDA approved epinephrine nasal spray (neffy; ARS Pharmaceuticals … phase 3 trials, the treatment significantly improved … CLEVER trial, clesrovimab reduced medically attended … biosimilar to ustekinumab (Stelara), in a 45mg …
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FDA news in pediatrics: June 2025
01 Jul 2025 20:03 GMT
… treatments without medication side effects.
On June 9, 2025, the FDA … phase 3 SMART trials, which demonstrated that … a biosimilar to ustekinumab (Stelara), in a 45mg… sebetralstat (KalVista Pharmaceuticals), an investigational oral treatment for hereditary …
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Latest from FDA: Zoryve foam, more psoriasis biosimilars, Keytruda for skin cancer
01 Jul 2025 18:34 GMT
… the eighth Stelara (ustekinumab, Janssen Biotech) biosimilar … FDA approved a supplemental new drug … treatment options were limited and often involved corticosteroids and immunosuppressants — medications … LTD, Novartis Pharmaceuticals Corp., Oruka Therapeutics …
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Celltrion obtains FDA OK for new presentation of Stelara biosimilar
27 Jun 2025 03:20 GMT
… obtained the Food and Drug Administration’s clearance for … is approved for the treatment of pediatric patients aged … ; clinical needs while supporting treatment continuity for patients, Celltrion … Solutions, Hikma get FDA nod for generic Stelara]
In December …
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Bio-Thera Solutions Receives Positive CHMP Opinion For USYMRO®(ustekinumab), A Biosimilar Referencing Stelara®
24 Jun 2025 13:32 GMT
… monoclonal antibody referencing Stelara®. The CHMP… treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical … candidates in clinical trials, focusing on … uncertainties inherent in pharmaceutical research and development, …
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Go on, pop the innovation pill: ₹5,000 cr push signals India’s shift from copy to create
23 Jun 2025 20:02 GMT
… blockbuster medicines like Humira for rheumatoid arthritis, Keytruda for cancer treatment, Stelara for … Pharma, and Bharat Serums and Vaccines (now part of Mankind Pharma … benefit companies bringing in innovative medicines. Drugs like AstraZeneca's …
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Megablockbusters are the holy grail. Here’s how drugmakers are getting there.
23 Jun 2025 13:22 GMT
… . For example, Vertex Pharmaceutical’s cystic fibrosis medication Trikafta/Kaftrio is … generation cardiometabolic drugs, as well, for a chance at treatments that work … with two megablockbusters: its immunology drug Stelara and an oncology therapy Darzalex …
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FDA Approves Celltrion’s New Pediatric Formulation of STEQEYMA, Expanding Dosing Flexibility
23 Jun 2025 23:41 GMT
… , 2025, Celltrion announced that the FDA has approved a new 45mg … strengths of its reference product, STELARA, including 45mg/0.5mL … been granted full interchangeability with STELARA across all indications.
[View source …
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Bio─Thera receives positive CHMP opinion for Usymro, a biosimilar referencing Stelara
23 Jun 2025 10:12 GMT
… biosimilar monoclonal antibody referencing Stelara. The CHMP’s positive … to commercialize the medicine upon approval and … to Janssen’s Stelara which is a … treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical …
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J&J Seeks FDA Approval of STELARA for Pediatric Crohn’s Disease
20 Jun 2025 20:51 GMT
… and Drug Administration (FDA) seeking to expand approval of STELARA (ustekinumab) for the treatment … Gasink, M.D., Vice President, Medical Affairs, Gastroenterology & Autoantibody, Johnson …