-
FDA Issues Second Camrelizumab/Rivoceranib CRL in Hepatocellular Carcinoma
21 Mar 2025 22:54 GMT
… evaluating treatment with camrelizumab/rivoceranib vs sorafenib (Nexavar) … -label phase 3 trial randomly assigned 543 … News release. Jiangsu Hengrui Pharmaceuticals Co., Ltd. May … Therapeutics announces FDA acceptance of new drug application resubmission …
-
FDA rejects Hengrui, Elevar's PD-1 cancer drug combination—again
22 Mar 2025 01:09 GMT
Jiangsu Hengrui Pharmaceuticals and its partner Elevar … combination for the first-line treatment of liver cancer, Hengrui said … by 36% versus Bayer’s Nexavar in those with first- … was “solely to unresolved site remediation at the camrelizumab facility.”
…
-
January - March 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
05 Mar 2025 21:57 GMT
… Counseling Information,” and “Medication Guide,” sections of the … Methylphenidate
Methylphenidate hydrochloride
Drug interaction between … )
Mvasi (bevacizumab-awwb)
Nexavar (sorafenib tosylate)
Ofev (nintedanib …
Example: Inlyta labeling
FDA determined that no …
-
First Patient Dosed With IO-108 in Phase 1b/2 HCC Trial
04 Mar 2025 03:01 GMT
… first patient in this trial represents a significant advancement … is currently FDA-approved for the treatment of patients … phase 3 IMbrave150 clinical trial, where the combination reduced … .0006) compared with sorafenib (Nexavar) alone.2 The combination also …
-
Key HCC Trial Data Establish the Role of Later-Line Cabozantinib and Raise Further Frontline Questions
20 Feb 2025 23:52 GMT
… Nexavar) in the frontline advanced HCC setting; current challenges addressing new treatments … Washington School of Medicine in Seattle.
… FDA-approved first-line treatment regimen [for HCC], whereas the COSMIC-312 trial … trials of [1 drug vs another] drug …
-
Immune Checkpoint Inhibitors Retain Their Role in the HCC Treatment Paradigm
20 Feb 2025 01:59 GMT
… time with sorafenib [Nexavar] as the prior … COSMIC-312 [NCT03755791] trials, which tried to combine … well-tolerated treatment regimen.
References
FDA approves tremelimumab … www.fda.gov/drugs/;resources-information-approved-drugs/fda-approves- …
-
FDA-Approved Fotivda Dose More Effective Than Reduced Dose in RCC
15 Feb 2025 21:09 GMT
… RCC), the Food and Drug Administration (FDA)-approved starting dose of … assistant professor of medicine at Harvard Medical School, all in … by the FDA in March 2021 for the treatment of adults … months in patients who received Nexavar (sorafenib, 175 patients). …
-
Liver Cancer Drugs Market To Achieve USD 2,332 Million By 2032, Powered By Innovative Treatments
04 Feb 2025 09:35 GMT
… cancer, access to innovative drug treatments remains critical. For … healthcare access.
- Leading Drug: Nexavar (Bayer) dominates the market … for traditional treatments. Ongoing clinical trials continue to … the pricing of cancer medicines can be prohibitive, …
-
Chong Kun Dang to exclusively distribute and sell Bayer's Nexavar and Stivarga
07 Feb 2025 08:09 GMT
… treatment Nexavar. Since their launches, both treatments have accumulated clinical evidence through clinical trials … Pharmaceutical, a company with differentiated competitiveness in the field of anticancer drugs …
-
Amid more drug-price scrutiny, biopharma companies largely keep their January hikes in check
29 Jan 2025 15:07 GMT
… government scrutiny for its high drug costs. One factor likely keeping … Hodgkin lymphoma treatment Matulane by 15%. In addition, Collegium Pharmaceuticals increased the … at 42% and Bayer’s Nexavar at 50%.