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FDA Issues Complete Response Letter for Glofit-GemOx in R/R DLBCL
18 Jul 2025 19:52 GMT
… ) in combination with gemcitabine (Gemzar; Eli Lilly and Co) … , MD, PhD, chief medical officer and head of global … its potential in additional treatment settings, including as frontline … of Clinical Oncology, the trial investigators enrolled 274 patients …
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Midyear Roundup: FDA’s Novel Oncology Drug Approvals in 2025
19 Jun 2025 00:47 GMT
… Pharmaceuticals)
Approval Date: February 14, 2025
Indication: For the treatment … ) and gemcitabine (Gemzar; Eli Lilly and … trials, AK105-304 (NCT04974398) and AK105-202 (NCT03866967). In each trial … fda.gov/drugs/;novel-drug-approvals-fda/novel-drug …
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TERZO Trial Doses First Patient With Copiktra in Rare T-Cell Lymphoma
09 Jun 2025 20:33 GMT
… during and after treatment.
The phase 3 trial will compare … Copiktra with investigator’s choice of Gemzar … growth and survival. The drug is approved in the … -cell lymphoma, including in trials sponsored by independent investigators. …
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FDA Approves Penpulimab-Kcqx for Indications in Nonkeratinizing Nasopharyngeal Carcinoma
24 Apr 2025 23:32 GMT
… (Gemzar; Eli Lilly and Company) for the first-line treatment of … AK105-202 (NCT03866967) clinical trials.1-3
The efficacy of … , multicenter phase 3 clinical trial AK105-304 (NCT04974398), which … months, according to the FDA. Additionally, the recommended single …
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FDA Grants Orphan Drug Designation to PEP-010 in Pancreatic Cancer
17 Mar 2025 17:15 GMT
… therapeutic peptide — for the treatment of patients with pancreatic … Dr. Hatem Azim, chief medical officer of PEP-Therapy, … ongoing trial is 53 patients.
"Receiving FDA’s [orphan drug designation … PEP-Therapy concludes by stating that the Company will …
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Atezolizumab, Immunogenic Chemotherapy Combination Shows Promise for DLBCL Treatment
14 Mar 2025 23:57 GMT
… (tecentriq) with rituximab (Rituxan), gemcitabine (gemzar), and oxaliplatin (eloxatin; GemOx; R … RT.
The multicenter phase 1 trial included centers at Emory University …
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IMM-1-104 Treatment May Improve Responses in Pancreatic Cancer
18 Jan 2025 01:51 GMT
… cancer, treatment of IMM-1-104 in combination with modified Gemzar plus … to expand the phase 2a trial to include three additional … Chair and Section Chief for Medical Oncology in the Department of … three phase 2a pancreatic cancer trial groups.
Of the seven …
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Boryung sings CDMO deal with Lotus Pharmaceutical to manufacture anticancer injection, expanding global reach
12 Dec 2024 05:50 GMT
… organization (CDMO) agreement with Lotus Pharmaceutical, a Taiwanese oncology specialist, for … and producing strategic original essential medicines for overseas markets, Boryung aims … domestic rights to the anticancer drug Gemzar (gemcitabine) in 2020, the …
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FDA Grants Rare Pediatric Disease Designation to Elraglusib for Ewing Sarcoma
13 Nov 2024 15:56 GMT
… ongoing phase 1/2 trial show promising anti-tumor activity … , the FDA granted orphan drug designation to elraglusib for the treatment of individuals … focusing on elraglusib plus gemcitabine (Gemzar; Eli Lilly) and nab-paclitaxel …
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Processa Pharmaceuticals Reports Third Quarter Business Highlights and Financial Results
30 Oct 2024 20:15 GMT
… Processa Pharmaceuticals. “Our NGC-Cap Phase 2 clinical trial in … S. Food and Drug Administration (FDA)-approved drugs to extend cancer … clinical trial (NCT06568692) evaluating NGC-Cap for the treatment of … oral analog of gemcitabine (Gemzar®) that is converted …