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Novartis radioligand therapy Lutathera® FDA approved as first medicine specifically for pediatric patients with gastroenteropancreatic neuroendocrine tumors
24 Apr 2024 02:54 GMT
… Food and Drug Administration (FDA) approved Lutathera® (lutetium … drugs to the FDA. Visit www.fda.gov/medwatch … implied discussions regarding potential marketing approvals, new indications … -radioligand-therapy-lutathera-fda-approved-as-first-medicine …
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FDA Grants Tovorafenib Approval to Treat Relapsed or Refractory Pediatric Low-Grade Glioma
23 Apr 2024 22:04 GMT
The FDA has granted accelerated approval to … side effects.3
READ MORE: FDA Approves Drug Combo for Young … will satisfy certain post-marketing requirements to the FDA.
Tovorafenib will be … of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric …
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Abeona Therapeutics Tanks On CRL From The FDA, But All Hope Is Not Lost
23 Apr 2024 21:49 GMT
… Complete Response Letter from the FDA in response to the … hopes were dashed as the FDA identified manufacturing issues that … room for error should the FDA provide further feedback that … there are operating, manufacturing and marketing risks that go beyond the …
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Day One’s OJEMDA™ (tovorafenib) Receives US FDA Accelerated Approval for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG), the Most Common Form of Childhood Brain Tumor
23 Apr 2024 19:56 GMT
… S. Food and Drug Administration (FDA) has approved OJEMDA (tovorafenib), … satisfy certain post-marketing requirements to the FDA. This study is … Disease designations by the FDA for the treatment of … Drug designation from the FDA for the treatment of …
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FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years and older with GEP-NETS
23 Apr 2024 17:45 GMT
…
This represents the first FDA approval of a radioactive drug … as recommended. A post-marketing requirement was issued to assess … and orphan drug designation; FDA expedited programs are described in … 402-0004 or email OncProjectFacilitate@fda.hhs.gov.
Follow the …
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FDA Approves Lutetium Lu 177 Dotatate in Pediatric SSTR+ GEP-NETs
23 Apr 2024 17:42 GMT
… marketing requirement was issued.
Previously, this treatment was approved by the FDA … the same indication.3
FDA approves lutetium Lu 177 … with GEP-NETS. News release. FDA. April 23, 2024. Accessed … ;shorturl.at/swJLY
FDA approves lutetium Lu 177 dotatate …
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XiFin to Highlight Impact of FDA Regulations, Other Disruptive Forces Facing Hospitals, Independent Labs, and Pathology Practices at 29th Annual Executive War College
23 Apr 2024 15:23 GMT
… . Chief among these is the FDA’s bid for control of …
Panel: Timing and Implications of FDA LDT Rule; Reforms to CLIA … Vice President, Product and Partner Marketing, Sandra Greefkes
Panel: Developing and …
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ImmunityBio’s ANKTIVA receives FDA approval for bladder cancer
23 Apr 2024 12:05 GMT
… Food and Drug Administration (FDA) has granted approval for … therapy designation from the FDA previously.
Based on the … 77 evaluable patients, the FDA granted approval.
During the … company in advancing the marketing of Anktiva and supports …
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Import alerts, warning letters, drug recalls — why ‘pharmacy to the world’ is facing US FDA heat
23 Apr 2024 08:14 GMT
… — govt’s new marketing code for drugmakers
Unending … different drugs following US FDA enforcement reports.
These … product quality standards.
The FDA communicates these violations to … letters. Additionally, the FDA and our international regulatory …
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Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency
22 Apr 2024 20:30 GMT
Docket Number:
FDA-2005-D-0208
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
We, FDA, are providing you, Investigational New Drug Application (IND) sponsors and Biologics License Application (BLA) applicants, …