Blog
RSS FeedPosted by Michael Wonder on 04 Apr 2019
FDA expands approved use of metastatic breast cancer treatment to include male patients
4 April 2019 - The U.S. Food and Drug Administration today is extending the indication of Ibrance (palbociclib) capsules in combination ...
Posted by Michael Wonder on 04 Apr 2019
FDA approves the reintroduction of Zelnorm (tegaserod) for irritable bowel syndrome with constipation in women under 65
1 April 2019 - In clinical trials, patients taking Zelnorm saw improvement in some of the most bothersome IBS-C symptoms, including ...
Posted by Michael Wonder on 03 Apr 2019
FDA approves Asceniv, a novel intravenous immune globulin
1 April 2019 - Approved for use in the treatment of primary humoral immunodeficiency disease in adults and adolescents (12 to ...
Posted by Michael Wonder on 03 Apr 2019
Evoke Pharma receives complete response letter and recommendations to address deficiencies from FDA for Gimoti NDA
2 April 2019 - Evoke Pharma today announced that it has received a complete response letter from the U.S. FDA ...
Posted by Michael Wonder on 01 Apr 2019
Circassia announces FDA approval of Tudorza supplemental new drug application
29 March 2019 - Data showing reduction in COPD exacerbations and no increase in major cardiovascular events vs placebo added to ...
Posted by Michael Wonder on 29 Mar 2019
FDA approves new oral treatment for multiple sclerosis
29 March 2019 - The U.S. FDA today approved Mavenclad (cladribine) tablets to treat relapsing forms of multiple sclerosis (MS) ...
Posted by Michael Wonder on 28 Mar 2019
FDA approves treatment for patients with a type of inflammatory arthritis
28 March 2019 - The U.S. FDA today approved Cimzia (certolizumab pegol) injection for treatment of adults with a certain type ...
Posted by Michael Wonder on 27 Mar 2019
FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism
27 March 2019 - The U.S. FDA today approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain ...
Posted by Michael Wonder on 26 Mar 2019
Novartis receives FDA approval for Mayzent (siponimod), the first oral drug to treat secondary progressive MS with active disease
26 March 2019 - Novartis today announced that the US FDA has approved Mayzent® (siponimod) for the treatment of adults with ...
Posted by Michael Wonder on 26 Mar 2019
Promedior received breakthrough therapy designation from FDA for PRM-151 in idiopathic pulmonary fibrosis
26 March 2019 - Promedior today announced that PRM-151, a novel investigational anti-fibrotic immunomodulator, has been granted breakthrough therapy designation ...
Posted by Michael Wonder on 23 Mar 2019
FDA issues complete response letter for Zynquista (sotagliflozin)
22 March 2019 - The U.S. FDA issued a complete response letter regarding the New Drug Application for investigational Zynquista ...
Posted by Michael Wonder on 23 Mar 2019
Recro Pharma receives complete response letter from the FDA for intravenous meloxicam
22 March 2019 - Recro Pharma today announced it has received a second complete response letter from the U.S. FDA Office ...
Posted by Michael Wonder on 21 Mar 2019
FDA approves new device for treating moderate to severe chronic heart failure in patients
21 March 2019 - The U.S. FDA today approved the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure ...
Posted by Michael Wonder on 21 Mar 2019
Jazz Pharmaceuticals announces U.S. FDA approval of Sunosi (solriamfetol) for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea
20 March 2019 - Sunosi is the first and only dual-acting dopamine and norepinephrine re-uptake inhibitor approved by the FDA to ...
Posted by Michael Wonder on 19 Mar 2019
FDA approves first treatment for post-partum depression
19 March 2019 - The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous use for the treatment ...