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  2. FDA Approves AstraZeneca's Datroway For Pretreated Breast ...

    www.aol.com/finance/fda-approves-astrazenecas...

    The approval was based on results from the TROPION-Breast01 Phase 3 trial. Read Next: AstraZeneca Aims to Restor FDA Approves AstraZeneca's Datroway For Pretreated Breast Cancer Patients

  3. Press Release: Sarclisa approved in the EU as the first anti ...

    lite.aol.com/tech/story/0022/20250122/1001044287.htm

    Based on the IKEMA phase 3 study, Sarclisa is also approved in 50 countries in combination with carfilzomib and dexamethasone, including in the US for the treatment of patients with R/R MM who have received 1–3 prior lines of therapy and in the EU for patients with MM who have received at least 1 prior therapy.

  4. Adjuvant Libtayo® (cemiplimab) Significantly Improves Disease ...

    lite.aol.com/tech/story/0022/20250113/9330581.htm

    About the Phase 3 Trial C-POST is an ongoing randomized, placebo-controlled, double-blind, multicenter, global Phase 3 trial investigating Libtayo versus placebo as adjuvant treatment for patients with features associated with a high-risk of CSCC recurrence and who have completed surgery and post-operative radiation therapy. Trial participants ...

  5. Vanzacaftor/tezacaftor/deutivacaftor - Wikipedia

    en.wikipedia.org/wiki/Vanzacaftor/tezacaftor/...

    The combination was approved for medical use in the United States in December 2024. [2] [3] ... Clinical trial number NCT05033080 for "A Phase 3 Study of VX-121 ...

  6. As bird flu becomes a growing threat, Moderna is awarded ...

    www.aol.com/finance/bird-flu-becomes-growing...

    A Phase 3 trial for mRNA-1018 is planned. Another Phase 3 trial will target H7N9, according to HHS. In order to combat “multiple health threats,” the agency added that Moderna will design up ...

  7. Multiple sclerosis drug pipeline - Wikipedia

    en.wikipedia.org/wiki/Multiple_sclerosis_drug...

    Treatment in MS Phase III studies is usually two years per patient. In July 2021, the FDA gave the go-ahead for an investigational new drug application (IND) for the phase 3 ENSURE program, which will evaluate IMU-838 in patients with relapsing-remitting multiple sclerosis (RRMS).

  8. Suzetrigine - Wikipedia

    en.wikipedia.org/wiki/Suzetrigine

    [1] [2] It is being developed by Vertex Pharmaceuticals and has completed two phase III clinical trials. [1] [3] Vertex Pharmaceuticals announced in January 2024 that suzetrigine had successfully met several endpoints in its phase III trials. The drug relieved moderate-to-severe post-surgical pain comparable to an opioid–acetaminophen ...

  9. New Drug Application - Wikipedia

    en.wikipedia.org/wiki/New_Drug_Application

    Some two-thirds of candidate drugs fail in Phase 2 clinical trials due to the drug not being as effective as anticipated. Phase 3: The drug is typically tested in several hundred to several thousand people with the targeted disease in double-blind, placebo controlled trials to demonstrate its specific efficacy. Under 30% of drug candidates ...