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RSS FeedPosted by Michael Wonder on 30 Aug 2019
SpringWorks Therapeutics receives breakthrough therapy designation for nirogacestat for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumours
29 August 2019 - SpringWorks Therapeutics today announced the U.S. FDA has granted breakthrough therapy designation for nirogacestat, an oral, selective, ...
Posted by Michael Wonder on 29 Aug 2019
U.S. FDA approves Mylan generic of Lilly lung cancer drug Alimta
29 August 2019 - The U.S. Food and Drug Administration on Thursday granted Mylan tentative approval for its generic version ...
Posted by Michael Wonder on 28 Aug 2019
FDA urges inclusion of men in breast cancer clinical trials
28 August 2019 - Men with breast cancer make up less than one percent of all breast cancer cases, but ...
Posted by Michael Wonder on 28 Aug 2019
Placebos and blinding in randomised controlled cancer clinical trials for drug and biological products: guidance for industry
28 August 2019 - This guidance provides recommendations to industry about the use of placebos and blinding in randomised controlled clinical ...
Posted by Michael Wonder on 22 Aug 2019
U.S. FDA grants Xtandi (enzalutamide) application priority review for the treatment of men with metastatic hormone-sensitive prostate cancer
21 August 2019 - Xtandi supplemental new drug application seeks to add an indication for men with prostate cancer that has ...
Posted by Michael Wonder on 21 Aug 2019
BeiGene announces U.S. FDA acceptance and grant of priority review for its new drug application of zanubrutinib in patients with relapsed/refractory Mantle cell lymphoma
21 August 2019 - BeiGene today announced that the U.S. FDA has accepted the company’s new drug application for zanubrutinib for ...
Posted by Michael Wonder on 18 Aug 2019
Roche cancer treatment priced at $17,050 a month, lower than rival Vitrakvi
17 August 2019 - Roche has priced its personalised cancer treatment, Rozlytrek, at about $17,050 per month, nearly half of ...
Posted by Michael Wonder on 18 Aug 2019
Roche drug approval offers a glimpse at the future of cancer treatment
15 August 2019 - The FDA on Thursday approved Roche’s cancer drug Rozlytrek for patients with any kind of tumour ...
Posted by Michael Wonder on 16 Aug 2019
FDA approves treatment for patients with rare bone marrow disorder
16 August 2019 - Today, the U.S. Food and Drug Administration approved Inrebic (fedratinib) capsules to treat adult patients with ...
Posted by Michael Wonder on 15 Aug 2019
FDA approves Genentech’s Rozlytrek (entrectinib) for people with ROS1-positive, metastatic non-small cell lung cancer and NTRK gene fusion-positive solid tumours
15 August 2019 - First FDA-approved treatment designed to target both ROS1 and NTRK that also shows response in cancer ...
Posted by Michael Wonder on 15 Aug 2019
FDA approves third oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumour
15 August 2019 - FDA also approves drug for second indication in a type of lung cancer. ...
Posted by Michael Wonder on 14 Aug 2019
FDA grants breakthrough therapy designation for trilaciclib based on myelopreservation data in small cell lung cancer patients
8 August 2019 - G1 Therapeutics today provided a corporate and financial update for the second quarter ended 30 June 2019. ...
Posted by Michael Wonder on 14 Aug 2019
Calquence granted US breakthrough therapy designation for chronic lymphocytic leukaemia
14 August 2019 - Designation based on positive results from two Phase III trials. ...
Posted by Michael Wonder on 03 Aug 2019
FDA approves first therapy for rare joint tumour
2 August 2019 - Today, the U.S. FDA granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients ...
Posted by Michael Wonder on 01 Aug 2019
Nektar Therapeutics and Bristol-Myers Squibb announce U.S. FDA breakthrough therapy designation for bempegaldesleukin (NKTR-214) in combination with Opdivo (nivolumab) for the treatment of patients with untreated advanced melanoma
1 August 2019 - Nektar Therapeutics and Bristol-Myers Squibb today announced that the U.S. FDA has granted breakthrough therapy designation for ...