Blog
RSS FeedPosted by Michael Wonder on 15 May 2019
AbbVie announces US FDA approval of Venclexta (venetoclax) as a chemotherapy-free combination regimen for previously untreated chronic lymphocytic leukaemia patients
15 May 2019 - FDA reviewed the submission under the real-time oncology review pilot program. ...
Posted by Michael Wonder on 15 May 2019
FDA approves Bavencio (avelumab) plus axitinib combination for patients with advanced renal cell carcinoma
14 May 2019 - Phase III study showed combination significantly lowered risk of disease progression or death by 31% and extended ...
Posted by Michael Wonder on 14 May 2019
FDA approves Eylea (aflibercept) injection for diabetic retinopathy
13 May 2019 - Eylea improves diabetic retinopathy and prevents worsening disease that can lead to blindness. ...
Posted by Michael Wonder on 14 May 2019
FDA approves broadened indication for Xeomin (incobotulinumtoxinA) as first-line treatment for blepharospasm (involuntary blinking) in adult patients
13 May 2019 - Merz Americas announced today that the U.S. FDA has approved the supplemental biologics license application for Xeomin ...
Posted by Michael Wonder on 13 May 2019
Lilly's Cyramza (ramucirumab) becomes first FDA approved biomarker-driven therapy in patients with hepatocellular carcinoma
13 May 2019 - This new indication - the fifth FDA approval for Cyramza in an advanced or metastatic cancer - ...
Posted by Michael Wonder on 13 May 2019
Intellipharmaceutics announces FDA approval for generic Pristiq
10 May 2019 - Intellipharmaceutics announced today that it has received approval from the U.S. FDA for the Company's abbreviated new ...
Posted by Michael Wonder on 12 May 2019
FDA approves prior approval supplement for Bivigam
10 May 2019 - ADMA Biologics announces that the U.S. FDA has approved the Company’s prior approval supplement for Bivigam (immune ...
Posted by Michael Wonder on 08 May 2019
FDA undercuts $375,000 drug in surprise move
8 May 2019 - The US FDA created a workaround this week that effectively undercuts the $375,000 price tag of ...
Posted by Michael Wonder on 07 May 2019
FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare auto-immune disorder
6 May 2019 - The U.S. FDA today approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome in patients ...
Posted by Michael Wonder on 06 May 2019
Pfizer gets U.S. approval for $225,000/year heart drug
6 May 2019 - The U.S. FDA on Monday approved Pfizer's oral drug, tafamidis, to treat a rare and fatal heart ...
Posted by Michael Wonder on 06 May 2019
FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin‑mediated amyloidosis
6 May 2019 - On May 3, the U.S. FDA approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment ...
Posted by Michael Wonder on 04 May 2019
FDA approves Genentech's Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neo-adjuvant treatment
3 May 2019 - Application approved under FDA’s real-time oncology review pilot program. ...
Posted by Michael Wonder on 04 May 2019
Qternmet XR approved in the US for the treatment of type 2 diabetes
3 May 2019 - The US FDA has approved Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) extended release tablets as ...
Posted by Michael Wonder on 03 May 2019
Acacia Pharma receives complete response letter from FDA for Barhemsys
3 May 2019 - Acacia Pharma announces that it has received a second complete response letter from the US FDA ...
Posted by Michael Wonder on 03 May 2019
Agios announces FDA approval of supplemental new drug application for Tibsovo as monotherapy for newly diagnosed adult patients with IDH1 mutant acute myeloid leukaemia not eligible for intensive chemotherapy
2 May 2019 - Approval based on 28 newly diagnosed patients from Phase 1 study of Tibsovo in advanced haematologic ...