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FDA’s Published CRLs Deliver Insight Into the Drug Approval Process
16 Jul 2025 17:44 GMT
… drug developer perform an additional adequate, well-controlled, randomized clinical trial … (Neupogen).28 … Pharmaceuticals, Inc. and Shilpa Medicare … Pharmaceuticals receives FDA approval for Lymphir (denileukin diftitox-cxdl) immunotherapy for the treatment …
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FDA authorizes Expanded Access Program of Anktiva for lymphopenia
07 Jun 2025 14:33 GMT
… approved by the FDA in 2024 for the treatment of patients … FDA in February 2025 for the management of lymphopenia.
Epogen and neupogen … , Illinois.2 Overall, the trial was assessing the use of … and global chief scientific and medical officer of ImmunityBio, in …
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Cancer Treatment Granted Lymphopenia Indication
04 Jun 2025 18:09 GMT
… .S. Food and Drug Administration (FDA) has granted Expanded … such as EPOGEN® and NEUPOGEN® to manage chemotherapy- … , and steroids. This treatment-acquired immunodeficiency not only … clinical impact, the pharmaceutical industry has largely overlooked …
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ImmunityBio Gets FDA Expanded Access for ANKTIVA in Solid Tumors
03 Jun 2025 12:37 GMT
… and steroids. This treatment-acquired immunodeficiency not only … clinical impact, the pharmaceutical industry has largely overlooked … such as EPOGEN and NEUPOGEN to manage chemotherapy- … Scientific and Medical Officer of ImmunityBio. “This FDA authorization …
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ASCO Report of Pioneering Treatment of Lymphopenia with Significant Overall Survival Benefit in Advanced Pancreatic Cancer
03 Jun 2025 13:04 GMT
… which have FDA-approved treatments like EPO and Neupogen, no therapy … is a vertically-integrated biotechnology company developing next- … improved survival, clinical trial and expanded access program … (v) whether clinical trials will result in registrational …
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ImmunityBio Receives FDA Expanded Access Authorization for Landmark Treatment of Lymphopenia With ANKTIVA®, the Cancer BioShield™ Platform, in Patients With Solid Tumors
02 Jun 2025 13:13 GMT
… clinical impact, the pharmaceutical industry has largely overlooked … which have FDA-approved treatments like EPOGEN and NEUPOGEN, no … a vertically-integrated biotechnology company developing next- … (v) whether clinical trials will result in registrational …
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Global Neupogen Filgrastim Market Forecast 2025-2034: Analyzing Growth Drivers, Share, Segments, And Emerging Trends
18 Mar 2025 12:51 GMT
… demand for cost-effective neutropenia treatments.
oExpanded healthcare access in emerging … .
oA greater focus on personalized medicine.
oA growing elderly population.
… Neupogen Filgrastim market is categorized into the following segments:
1.By Drug …
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Bioengineered Protein Drugs Market Size to Cross USD 672.7 Billion by 2034, Growing at a CAGR of 6.2% - Report by Transparency Market Research, Inc.
13 Mar 2025 22:00 GMT
… modeling and drug development.
Advancements in Drug Delivery … Personalized Medicine – Precision biologic therapies are reshaping treatment … Proteins
Hormones
Cytokines
Neupogen
Neulasta
Interferon … Dominates with advanced biotech infrastructure and strong …
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ImmunityBio receives US FDA's regenerative medicine advanced therapy designation for Anktiva and CAR─NK for metastatic pancreatic cancer
01 Mar 2025 12:08 GMT
… Inc, a leading biotechnology company addressing cancer … the US FDA has granted Regenerative Medicine Advanced Therapy … the physician for the treatment of anemia, neutropenia … therapies, including Epogen, Neupogen and platelet transfusion, respectively …
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ImmunityBio Receives FDA RMAT Designation for ANKTIVA® and CAR-NK for the Reversal of Lymphopenia in Patients Receiving Standard-of-Care Chemotherapy/Radiotherapy and in Treatment of Multiply Relapsed Locally Advanced or Metastatic Pancreatic Cancer
28 Feb 2025 00:31 GMT
… including EPOGEN, NEUPOGEN and platelet transfusion … a leading biotechnology company … Drug Administration (FDA) indicated with Bacillus Calmette-Guérin (BCG) for the treatment … trials will result in registrational pathways, (vi) whether clinical trial …
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