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The HDAC inhibitor was given an accelerated approval by the FDA as a second-line PTCL therapy on the strength of overall response data, but a phase 3 study comparing Istodax to first-line chemotherapy showed no improvement on progression-free survival (PFS).
AZ is seeking to use Lynparza in patients who had also been previously treated with the chemotherapy drug docetaxel, but NICE has concluded that the application failed to provide evidence of the PARP inhibitor’s value compared to standard therapy.
At NeoImmuneTech, a Biotech company founded in Maryland, US, in 2014, the answer to this question looks straightforward: “We believe in incremental progress”, says Dr Se Hwan Yang, president and chief executive officer of the company. Dr Se Hwan Yang, PhD, President and Chief Executive Officer, founded NeoImmuneTech in January 2014.
On March 27, MSD announced that the combined use of Keytruda with chemotherapy significantly improved progression-free survival versus the chemotherapy alone, as a first-line therapy for advanced or recurrent endometrial carcinoma. This announcement is not the only recent development for Keytruda.
The EAMS – first introduced in 2014 – provides a route for drugmakers to provide earlier availability of promising new unlicensed medicines to patients with few treatment options, allowing clinicians and patients to try it before it’s been formally given the thumbs up.
Of note, the US Food and Drug Administration (FDA) and ANSM (French regulatory authorities) have established themselves as early leaders to develop guidelines. Since these fresh FDA approvals for microbiome-based therapies, regulatory pathways are becoming clearer and opening new perspectives for companies.
In December 2014, Amgen’s landmark FDA approval saw Blincyto (blinatumomab) approved for relapsed/refractory (R/R) B-cell progenitor acute lymphoblastic leukaemia (B-ALL), at the time being the only marketed BiTE. months vs. 4.0
Amgen’s Blincyto (blinatumomab) was the first bispecific T cell engager to be approved for marketing way back in 2014, but has been a slow burner product for Amgen, with sales rising slowly to $472 million last year in its main indication in B-cell acute lymphoblastic leukaemia (B-ALL). years’ follow-up. .”
Antiemetics may also reduce radiation-associated or chemotherapy-induced nausea resulting from cancer treatment. Kaopectate tablet and liquid suspension Bismuth subsalicylate is FDA-approved for treating nausea and vomiting. These medications can help with motion sickness, vertigo, postoperative nausea, and morning sickness.
During the research, I noticed a significant increase in the number of FDA approvals for bispecific antibodies in recent years. One area of interest is in oncology , where bispecific antibodies can be used to target two different antigens at the same time, leading to improved efficacy and reduced toxicity compared to traditional chemotherapy.
Tramadol has been available in the United States since 1995, but not until 2014 did it become a schedule IV controlled substance by the Food and Drug Administration (FDA) based on data suggesting abuse potential similar to other schedule IV opioids available at that time. What can I take in place of tramadol?
Today, it is approved by the Food and Drug Administration ( FDA ) for chronic musculoskeletal pain—like low back pain , neuropathic pain associated with diabetes mellitus , and fibromyalgia; it is used off-label for chemotherapy-induced peripheral neuropathy.
Plecanatide : This is one of the newest medications for IBS-C that has been approved by the FDA. Tenapanor : Tenapanor was approved by the FDA in September of 2019 for IBS-C. [45] As the intestines are made of smooth muscles, a reduction in the action of these muscles can slow down digestion and cause constipation. 2020;12(1):205.
Three years after Daiichi Sankyo’s FLR3 inhibitor quizartinib was rejected by the FDA, the drugmaker has reported the results of a new phase 3 trial that is key to getting the drug to the US market and chasing down rival drugs from Astellas and Novartis. Quizartinib plus standard chemotherapy reduced the risk of death by 22.4%
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