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RSS FeedPosted by Michael Wonder on 26 Sep 2019
FDA approves daratumumab for transplant eligible multiple myeloma
26 September 2019 - The FDA has today approved daratumumab (Darzalex, Janssen) for adult patients with multiple myeloma in combination ...
Posted by Michael Wonder on 26 Sep 2019
FDA approves treatment for adults and children with all genotypes of hepatitis C and compensated cirrhosis that shortens duration of treatment to eight weeks
26 September 2019 - The U.S. FDA today expanded the approval of Mavyret (glecaprevir and pibrentasvir) tablets for an eight week ...
Posted by Michael Wonder on 26 Sep 2019
Ipsen announces FDA approval of Dysport (abobotulinumtoxinA) for the treatment of upper limb spasticity in children, excluding cerebral palsy
26 September 2019 - Dysport is the first and only FDA approved botulinum toxin for treatment of both paediatric upper and ...
Posted by Michael Wonder on 25 Sep 2019
FDA approves first live, non-replicating vaccine to prevent smallpox and monkeypox
24 September 2019 - The U.S. FDA announced today the approval of Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating, for the ...
Posted by Michael Wonder on 22 Sep 2019
Merck’s Pifelto (doravirine) and Delstigo (doravirine/lamivudine/tenofovir disoproxil fumarate) receive US FDA approval for use in appropriate adults living with HIV-1 who are virologically suppressed
20 September 2019 - Approvals based on findings from the Phase 3 DRIVE-SHIFT Trial evaluating a switch to Delstrigo. ...
Posted by Michael Wonder on 21 Sep 2019
FDA approves first oral GLP-1 treatment for type 2 diabetes
20 September 2019 - The U.S. FDA today approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult ...
Posted by Michael Wonder on 18 Sep 2019
Susan G. Komen Big Data for Breast Cancer Initiative: how patient advocacy organisations can facilitate using big data to improve patient outcomes
12 September 2019 - Integrating different types of data, including electronic health records, imaging data, administrative and claims databases, large data ...
Posted by Michael Wonder on 18 Sep 2019
U.S. FDA approves supplemental new drug application for Erleada (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer
17 September 2019 - Phase 3 TITAN is the first registrational study to achieve statistical significance in dual primary endpoints of ...
Posted by Michael Wonder on 12 Sep 2019
Ardelyx receives FDA approval for Ibsrela (tenapanor), an NHE3 sodium transport inhibitor, for the treatment of irritable bowel syndrome with constipation
12 September 2019 - Approval supported by two Phase 3 trials demonstrating a statistically significant reduction in constipation and abdominal pain ...
Posted by Michael Wonder on 12 Sep 2019
Nucala is the first biologic approved in the US for six to 11-year-old children with severe eosinophilic asthma
12 September 2019 - GlaxoSmithKline today announced that the US FDA has approved Nucala (mepolizumab) for use in children as young ...
Posted by Michael Wonder on 12 Sep 2019
Aspen's drug to prevent preterm birth approved by FDA
13 September 2019 - The U.S. Food and Drug Administration (FDA) has approved Aspen Pharmacare’s hydroxyprogesterone caproate, which is used to ...
Posted by Michael Wonder on 10 Sep 2019
Xeris Pharmaceuticals receives U.S. FDA approval for Gvoke (glucagon), the first ready-to-use stable liquid glucagon for severe hypoglycaemia
10 September 2019 - First approval for Xeris is based on positive efficacy and safety results from multiple clinical studies. ...
Posted by Michael Wonder on 10 Sep 2019
ProQR receives fast track designation from FDA for QR-1123 for autosomal dominant retinitis pigmentosa
9 September 2019 - ProQR Therapeutics today announced that it received fast track designation from the FDA for QR-1123. ...
Posted by Michael Wonder on 09 Sep 2019
Reeling from scandal, Novartis vows to voluntarily release info on manipulated data in the future
9 September 2019 - Seeking to appease angry regulators, Novartis committed to notifying the FDA within five business days of ...
Posted by Michael Wonder on 07 Sep 2019
FDA approves first treatment for patients with rare type of lung disease
6 September 2019 - The U.S. FDA today approved Ofev (nintedanib) capsules to slow the rate of decline in pulmonary ...