Blog
RSS FeedPosted by Michael Wonder on 18 May 2020
FDA approves Genentech’s Tecentriq as a first-line monotherapy for certain people with metastatic non-small cell lung cancer
18 May 2020 - Tecentriq’s fourth indication in metastatic non-small cell lung cancer and fifth indication in lung cancer overall. ...
Posted by Michael Wonder on 18 May 2020
Blueprint pays the price of Ayvakit phase 3 miss as FDA rejects drug
18 May 2020 - The FDA has turned down Blueprint Medicines’ Ayvakit for more general use in gastro-intestinal stromal tumour ...
Posted by Michael Wonder on 17 May 2020
Blueprint Medicines receives complete response letter from FDA for avapritinib new drug application for the fourth-line treatment of gastro-intestinal stromal tumour
15 May 2020 - Blueprint Medicines today announced that the U.S. FDA has issued a complete response letter for the new ...
Posted by Michael Wonder on 15 May 2020
FDA approves first drug for fourth-line treatment of advanced gastro-intestinal stromal tumours
15 May 2020 - Today, the U.S. FDA approved Qinlock (ripretinib) tablets as the first new drug specifically approved as a ...
Posted by Michael Wonder on 15 May 2020
FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer
15 May 2020 - Today the FDA granted accelerated approval to rucaparib (Rubraca, Clovis Oncology) for patients with deleterious BRCA ...
Posted by Michael Wonder on 15 May 2020
U.S. FDA approves Opdivo (nivolumab) + Yervoy (ipilimumab) as first-line treatment of patients with metastatic non-small cell lung cancer whose tumours express PD-L1≥1%
15 May 2020 - Fifth indication for Opdivo + Yervoy, the first and only FDA-approved dual immunotherapy. ...
Posted by Michael Wonder on 15 May 2020
U.S. Food and Drug Administration approves Bristol Myers Squibb’s Pomalyst (pomalidomide) for AIDS-related and HIV-negative Kaposi sarcoma
15 May 2020 - Pomalyst is the only oral and first new treatment option for Kaposi sarcoma in more than 20 ...
Posted by Michael Wonder on 14 May 2020
Sunovion discontinues dasotraline program
13 May 2020 - Sunovion Pharmaceuticals today announced that it has withdrawn the new drug applications for dasotraline, a novel ...
Posted by Michael Wonder on 09 May 2020
Lynparza (olaparib) approved by FDA as first-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer
8 May 2020 - Improved the median time to disease progression (37.2 months) vs. bevacizumab alone (17.7 months) following response ...
Posted by Michael Wonder on 08 May 2020
FDA approves first therapy for patients with lung and thyroid cancers with a certain genetic mutation or fusion
8 May 2020 - Today, the U.S. FDA approved Retevmo (selpercatinib) capsules to treat three types of tumours – non-small cell ...
Posted by Michael Wonder on 07 May 2020
Dr. Reddy's Laboratories received approval for their NDA, Elyxyb (celecoxib 25 mg/mL oral solution) in the U.S
6 May 2020 - Dr. Reddy’s Laboratories today announced approval of Elyxyb (celecoxib 25 mg/mL oral solution) by the U.S. FDA. ...
Posted by Michael Wonder on 06 May 2020
FDA approves first targeted therapy to treat aggressive form of lung cancer
6 May 2020 - Today, the U.S. FDA approved Tabrecta (capmatinib) for the treatment of adult patients with non-small cell lung ...
Posted by Michael Wonder on 05 May 2020
FDA approves new treatment for a type of heart failure
5 May 2020 - Today, the U.S. FDA approved Farxiga (dapagliflozin) oral tablets for adults with heart failure with reduced ejection ...
Posted by Michael Wonder on 04 May 2020
FDA approves Fensolvi (leuprolide acetate) for injectable suspension for paediatric patients with central precocious puberty
4 May 2020 - Fensolvi is the only six-month, subcutaneously administered leuprolide acetate approved for the treatment of paediatric patients two ...
Posted by Michael Wonder on 04 May 2020
Gilead’s investigational anti-viral remdesivir receives U.S. FDA emergency use authorisation for the treatment of COVID-19
1 May 2020 - Authorisation enables broader use of remdesivir to treat hospitalised patients with severe COVID-19 disease in the United ...