Blog
RSS FeedPosted by Michael Wonder on 03 Jun 2019
FDA approves new treatment for hospital-acquired and ventilator-associated bacterial pneumonia
3 June 2019 - The U.S. FDA today approved a new indication for the previously FDA approved drug, Zerbaxa (ceftolozane and ...
Posted by Michael Wonder on 31 May 2019
U.S. FDA approves supplemental new drug application adding overall survival data for Xospata (gilteritinib)
30 May 2019 - Phase 3 ADMIRAL trial showed patients treated with Xospate demonstrated longer overall survival than those who ...
Posted by Michael Wonder on 29 May 2019
FDA approves Revlimid (lenalidomide) in combination with rituximab for the treatment of adult patients with previously treated follicular lymphoma or marginal zone lymphoma
28 May 2019 - Approval marks the first chemotherapy-free combination regimen for patients who have relapsed or did not respond to ...
Posted by Michael Wonder on 28 May 2019
Allergan and Gedeon Richter receive U.S. FDA approval for expanded use of Vraylar (cariprazine) in the treatment of bipolar depression
28 May 2019 - New indication makes Vraylar first and only dopamine and serotonin partial agonist to treat the full spectrum ...
Posted by Michael Wonder on 25 May 2019
RegenxBio announces first FDA approval of a gene therapy based on its proprietary NAV technology platform
24 May 2019 - FDA approval of Novartis' Zolgensma for the treatment of paediatric patients with SMA marks the first regulatory ...
Posted by Michael Wonder on 24 May 2019
FDA approves Jakafi (ruxolitinib) for the treatment of patients with acute graft-versus-host disease
24 May 2019 - Jakafi is the first and only FDA approved treatment for patientswith steroid-refractory acute graft-versus-host disease. ...
Posted by Michael Wonder on 24 May 2019
FDA approves first PI3K inhibitor for breast cancer
24 May 2019 - Today, the U.S. FDA approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved ...
Posted by Michael Wonder on 24 May 2019
FDA approves innovative gene therapy to treat paediatric patients with spinal muscular atrophy, a rare disease and leading genetic cause of infant mortality
24 May 2019 - The U.S. FDA today approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less ...
Posted by Michael Wonder on 23 May 2019
FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections
23 May 2019 - Today, the U.S. FDA permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for ...
Posted by Michael Wonder on 22 May 2019
FDA approves Sorilux for adolescent plaque psoriasis
22 May 2019 - Mayne Pharma is pleased to announce that the US FDA has approved Sorilux (calcipotriene) foam, 0.005% ...
Posted by Michael Wonder on 20 May 2019
UCB announces Nayzilam (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the US
19 May 2019 - Nayzilam allows for administration by a non-healthcare professional in patients actively seizing when and where a seizure ...
Posted by Michael Wonder on 18 May 2019
U.S. FDA approves Gattex (teduglutide) for children 1 year of age and older with short bowel syndrome
17 May 2019 - Gattex is the only glucagon-like peptide-2 analogue approved that improves intestinal absorption in patients with SBS who ...
Posted by Michael Wonder on 16 May 2019
FDA approves first anticoagulant (blood thinner) for paediatric patients to treat potentially life-threatening blood clots
16 May 2019 - The U.S. FDA today approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of ...
Posted 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 ...