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FDA’s new draft guidance follows the new requirement for clinical…
FDA’s new draft guidance follows the new requirement for clinical study sponsors to submit Diversity Action Plans, eg, when submitting their investigational new drug (IND) application.
Approval of the first treatment option for desmoid tumours beyond…
Approval of the first treatment option for desmoid tumours beyond surgery and radiation has been granted by the US Food and Drug Administration (FDA).
The first targeted therapy for certain adults with the rare…
The first targeted therapy for certain adults with the rare blood cancer myelodysplastic syndromes, has been approved by the US Food and Drug Administration (FDA).
Jemperli (dostarlimab) was granted accelerated approval after 42.3 percent recurrent…
Jemperli (dostarlimab) was granted accelerated approval after 42.3 percent recurrent or advanced endometrial cancer patients with deficient mismatch repair responded in a trial.
The FDA has given approval to Phesgo for injection under…
The FDA has given approval to Phesgo for injection under the skin to treat HER2-positive breast cancer, meaning it can be administered at home by a healthcare professional.
The US FDA has granted accelerated approval of Trodelvy (sacituzumab…
The US FDA has granted accelerated approval of Trodelvy (sacituzumab govitecan-hziy), to treat triple-negative breast cancer in adult patients.
The FDA has approved Ayvakit for the treatment of GISTs…
The FDA has approved Ayvakit for the treatment of GISTs with platelet-derived growth factor receptor alpha mutations, following 84 percent response rate in clinical trials.
The US Food and Drug Administration has approved first-line treatment…
The US Food and Drug Administration has approved first-line treatment for newly diagnosed peripheral T-cell lymphoma using a new review program...
“Patients will now have an approved therapy that has been…
“Patients will now have an approved therapy that has been shown to decrease the need for blood pressure medication and reduce tumour size in some patients.”
The FDA has approved Doptelet tablets to treat low blood…
The FDA has approved Doptelet tablets to treat low blood platelet count in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure...
The U.S. Food and Drug Administration has approved Tafinlar and…
The U.S. Food and Drug Administration has approved Tafinlar and Mekinist administered together, for the treatment of anaplastic thyroid cancer that cannot be removed by surgery...
The FDA has granted accelerated approval to Blincyto to treat adults and…
The FDA has granted accelerated approval to Blincyto to treat adults and children with B-cell precursor acute lymphoblastic leukaemia (ALL)...
The FDA has approved Adcetris to treat adult patients with…
The FDA has approved Adcetris to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy...
The FDA has approved Imfinzi for the treatment of patients…
The FDA has approved Imfinzi for the treatment of patients with stage III non-small cell lung cancer whose tumours are not able to be surgically removed and whose cancer has not progressed after treatment...
The FDA has approved Lutathera for the treatment of a…
The FDA has approved Lutathera for the treatment of a type of cancer that affects the pancreas the gastrointestinal tract...
