Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 02 May 2019
First FDA approved vaccine for the prevention of dengue disease in endemic regions
1 May 2019 - The U.S. FDA announced today the approval of Dengvaxia, the first vaccine approved for the prevention of ...
Posted by Michael Wonder on 01 May 2019
FDA approves Kalydeco (ivacaftor) as first and only CFTR modulator to treat eligible infants with CF as early as six months of age
30 April 2019 - Safety data from Phase 3 ARRIVAL study support treatment with Kalydeco in children ages six to <12 ...
Posted by Michael Wonder on 01 May 2019
Nabriva Therapeutics receives complete response letter from FDA on NDA for intravenous Contepo (fosfomycin) for injection
30 April 2019 - Issues related to facility inspections and manufacturing deficiencies at one contract manufacturer. ...
Posted by Michael Wonder on 01 May 2019
FDA approves first treatment for all genotypes of hepatitis C in paediatric patients
30 April 2019 - The U.S. FDA today approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of ...