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RSS FeedPosted by Michael Wonder on 05 Aug 2015
FDA approves Boehringer Ingelheim’s Stiolto Respimat as once-daily maintenance treatment for COPD
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved once-daily Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray. ...
Posted by Michael Wonder on 05 Aug 2015
FDA launches openFDA to provide easy access to valuable FDA public data
2 Jun 2014 - Today, the U.S. Food and Drug Administration launched openFDA, a new initiative designed to make it easier ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves new treatment for rare form of hemophilia
The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes ...
Posted by Michael Wonder on 05 Aug 2015
First FDA breakthrough therapy designation for KLH-conjugate immunotherapy signals key step for novel carrier molecule
Stellar Biotechnologies, Inc., the leader in sustainable manufacture of Keyhole Limpet Hemocyanin ("KLH") is encouraged that the U.S. Food and ...
Posted by Michael Wonder on 05 Aug 2015
Eylea (aflibercept) injection receives FDA breakthrough therapy designation for diabetic retinopathy in patients with diabetic macular oedema
Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Eylea (aflibercept) Injection Breakthrough Therapy designation for ...
Posted by Michael Wonder on 05 Aug 2015
Shire announces FDA acceptance for filing with priority review of supplemental new drug application (sNDA) for Vyvanse (lisdexamfetamine dimesylate) capsules for adults with binge eating disorder
Shire plc, the global specialty biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has accepted for ...
Posted by Michael Wonder on 05 Aug 2015
Pfizer announces FDA acceptance for review of new drug application for a once-daily formulation of Xeljanz (tofacitinib citrate) modified release rablets
Pfizer Inc. announced today that the United States Food and Drug Administration (FDA) accepted for review Pfizer’s new drug application ...
Posted by Michael Wonder on 05 Aug 2015
DBV Technologies receives FDA breakthrough therapy designation for Viaskin Peanut for the treatment of peanut allergy in children
DBV Technologies, a clinical-stage specialty biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough ...
Posted by Michael Wonder on 05 Aug 2015
Rockwell Medical announces FDA acceptance for filing of Triferic New Drug Application
Rockwell Medical, Inc, a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Cholbam to treat rare bile acid synthesis disorders
Today the U.S. Food and Drug Administration approved Cholbam (cholic acid) capsules, the first FDA approved treatment for pediatric and ...
Posted by Michael Wonder on 05 Aug 2015
Sanofi receives FDA approval of Priftin (rifapentine) tablets for the treatment of latent tuberculosis infection
Sanofi announced today that following a priority review, the U.S. Food and Drug Administration has approved Priftin (rifapentine) in combination with ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Viekira Pak to treat hepatitis C
The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves new treatment for cystic fibrosis
The U.S. Food and Drug Administration today approved the first drug for cystic fibrosis directed at treating the cause of ...
Posted by Michael Wonder on 05 Aug 2015
Olysio (simeprevir) gains additional FDA approval as once-daily, all-oral interferon- and ribavirin-free treatment option in combination with sofosbuvir for adults with genotype 1 chronic hepatitis C infection
Janssen Therapeutics, Division of Janssen Products, LP (Janssen) announced the U.S. Food and Drug Administration (FDA) has approved Olysio (simeprevir), a ...
Posted by Michael Wonder on 05 Aug 2015
Teva announces FDA approval of Qnasl (beclomethasone dipropionate) nasal aerosol for treatment of children with seasonal and perennial allergic rhinitis
Teva Pharmaceutical Industries Ltd., announced today that the U.S. Food and Drug Administration (FDA) approved Qnasl (beclomethasone dipropionate) 40 mcg for the ...