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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: …
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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 …
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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, …
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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
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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 …
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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 …
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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 …
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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 …
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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 …
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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 …