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RSS FeedPosted by Michael Wonder on 14 Feb 2018
FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint
14 February 2018 - The U.S. FDA today approved Erleada (apalutamide) for the treatment of patients with prostate cancer that ...
Posted by Michael Wonder on 13 Feb 2018
Statement from FDA Commissioner Scott Gottlieb on Administration’s request for new FDA funding to promote innovation and broaden patient access through competition
13 February 2018 - Additional resources will help advance initiatives to support novel medical technology and public health priorities such as ...
Posted by Michael Wonder on 13 Feb 2018
Icon Bioscience receives FDA approval for Dexycu, a potentially transformational drug therapy for treating inflammation associated with cataract surgery
12 February 2018 - Icon Bioscience today announced that the United States FDA has approved the company's new drug application for ...
Posted by Michael Wonder on 13 Feb 2018
Sandoz announces US FDA approval and launch of Glatopa 40 mg/mL three times-a-week generic option for relapsing forms of multiple sclerosis
13 February 2018 - Glatopa 40 mg/mL is a fully substitutable, AP-rated generic version of Copaxone (glatiramer acetate injection) 40 mg/mL. ...
Posted by Michael Wonder on 13 Feb 2018
U.S., EU and Japan health authorities accept regulatory submissions for review of Pfizer's third-generation ALK inhibitor lorlatinib
12 February 2018 - U.S. new drug application granted FDA priority review. ...
Posted by Michael Wonder on 13 Feb 2018
FDA approves Symdeko (tezacaftor/ivacaftor and ivacaftor) to treat the underlying cause of cystic fibrosis in people ages 12 and older with certain mutations in the CFTR gene
12 February 2018 - Symdeko to begin shipping to pharmacies this week. ...
Posted by Michael Wonder on 12 Feb 2018
Adamis Pharmaceuticals announces FDA acceptance for review for the supplemental new drug application of its low dose Symjepi product candidate
12 February 2018 - Adamis Pharmaceuticals Corporation today announced that the U.S. FDA has accepted for review the company’s supplemental ...
Posted by Michael Wonder on 12 Feb 2018
U.S. FDA files new drug application under priority review for migalastat for treatment of Fabry disease
12 February 2018 - Six month PDUFA goal date is 13 August 2018. ...
Posted by Michael Wonder on 11 Feb 2018
Salix provides update on FDA submission for Plenvu
9 February 2018 - Salix Pharmaceuticals and its partner Norgine have received notice that the U.S. FDA has extended the PDUFA ...
Posted by Michael Wonder on 11 Feb 2018
F.D.A. chief goes against the administration stereotype
11 February 2018 - Dr. Scott Gottlieb isn’t rolling back his agency’s mission, although he is straddling the interests of ...
Posted by Michael Wonder on 10 Feb 2018
Grifols HyperRAB (rabies immune globulin [human]) 300 IU/mL receives FDA approval to treat patients exposed to rabies virus infection
6 February 2018 - Reduced volume of medication offers potential for fewer injections for patients. ...
Posted by Michael Wonder on 09 Feb 2018
60 Degrees Pharmaceuticals receives priority review designation for malaria drug
7 February 2018 - 60 Degrees Pharmaceuticals received priority review designation from the US FDA for tafenoquine for prevention of malaria ...
Posted by Michael Wonder on 09 Feb 2018
Zytiga (abiraterone acetate) plus prednisone approved for treatment of earlier form of metastatic prostate cancer
8 February 2018 - Findings from pivotal Phase 3 LATITUDE clinical trial data demonstrated statistically significant and clinically meaningful improvements in ...
Posted by Michael Wonder on 08 Feb 2018
Novartis receives FDA approval for Cosentyx label update to include moderate-to-severe scalp psoriasis
8 February 2018 - This follows a similar European label update in June 2017. ...
Posted by Michael Wonder on 08 Feb 2018
Sage Therapeutics receives FDA breakthrough therapy designation for SAGE-217 for the treatment of major depressive disorder
7 February 2018 - Designation offers potential for expedited development and review, and highlights the urgent need for additional treatment options ...