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    • FDA Approvals

FDA Approvals Newsletter
  • FDA Approves Lutathera for Pediatric GEP-NETs 23 Apr 2024 16:49 GMT

    The Food and Drug Administration (FDA) approved Lutathera (lutetium Lu 177) … . This is the first FDA approval of a radioactive drug for … the release noted. The approval is based off findings from … also considered by the FDA in the approval process. READ MORE: …

  • FDA Approves New Bladder Cancer Drug 23 Apr 2024 13:46 GMT

    The US Food and Drug Administration (FDA) has approved the first-in-class interleukin ( … papillary disease.  The FDA declined an initial approval for the combination in … ImmunityBio, which acquired Altor BioScience.  Approval was based on findings from …

  • Ziftomenib Granted Breakthrough Therapy Designation by FDA in R/R AML 23 Apr 2024 16:49 GMT

    The Food and Drug Administration (FDA) has granted Breakthrough Therapy … “We are highly encouraged by FDA’s decision to grant Breakthrough … for which there is no approved targeted therapy as well … AML or MDS Diagnosis The FDA, according to Kura Oncology, …

  • This Pharma Co. Kicks Off FDA Approval Process For CBD-Based Treatment Of Chronic Pain 23 Apr 2024 15:16 GMT

    … meeting with the U.S. Food and Drug Administration (FDA), for its Liposome-Cannabidiol (LPT … regulatory process with the FDA for the approval of its prolonged CBD … and when it should become FDA-approved has the potential of … Revenue As It Pursues FDA Approval

  • FDA rejects Abeona cell therapy, asks for more manufacturing data 23 Apr 2024 15:58 GMT

    The Food and Drug Administration has rejected an experimental … provide manufacturing data prior to approval and full “validation” … Seshadri added. Nonetheless, the FDA rejection delays the arrival of … from Krystal Biotech was approved last year for people …

  • Piggy Sooy: Moolec Gains USDA Approval for Pork Proteins Grown in Soybeans 23 Apr 2024 16:56 GMT

    … proteins. Moolec has received approval from the USDA for … soybeans. The USDA APHIS approval allows the startup to accelerate … But while the APHIS approval means its pork soybeans … other agencies – chiefly the Food and Drug Administration – will be key for …

  • FDA Issues Complete Response Letter for Abeona's Pz-cel for Epidermolysis Bullosa 23 Apr 2024 15:35 GMT

    … . announced yesterday that the US Food and Drug Administration (FDA) has issued a Complete Response … and Controls requirements before granting approval. Specifically, the CRL highlights specific …

  • Europe Approves Paroxysmal Nocturnal Hemoglobinuria Drug 23 Apr 2024 15:17 GMT

    … inhibitor danicopan (Voydeya) has been approved by the European Commission as … breakthrough therapy by the US Food and Drug Administration; given Priority Medicines status by … Union, and Japan. European Commission approval of danicopan as an addition …

  • FDA approves ImmunityBio's bladder cancer therapy Anktiva 23 Apr 2024 13:41 GMT

    Im­mu­ni­ty­Bio scored an FDA ap­proval for its once-re­ject­ed drug … in pre­mar­ket trad­ing. The agency ap­proved the drug Ank­ti­va, an IL …

  • FDA Issues CRL for Epidermolysis Bullosa Gene Therapy 23 Apr 2024 16:49 GMT

    … concluded on March 1. The FDA issued a complete response letter … submission was insufficient for the FDA's review by the … . Abeona plans to address the FDA's requests and resubmit … the issues prior to BLA approval, with full reports provided after …

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