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RSS FeedPosted 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 ...
Posted by Michael Wonder on 05 Aug 2015
Amgen's BiTE immunotherapy blinatumomab receives FDA priority review designation in acute lymphoblastic leukaemia
Amgen today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for the investigational ...
Posted by Michael Wonder on 05 Aug 2015
Teva and Eagle Pharmaceuticals announce NDA for bendamustine rapid infusion product accepted for filing
Teva Pharmaceutical Industries Ltd. and Eagle Pharmaceuticals, Inc. today announce that the New Drug Application (NDA) for a liquid bendamustine hydrochloride (HCl) rapid ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Rapivab to treat flu infection
On December 19, the U.S. Food and Drug Administration approved Rapivab (peramivir) to treat influenza infection in adults. ...
Posted by Michael Wonder on 05 Aug 2015
FDA accepts BPL’s amended BLA submission for Coagadex (coagulation factor X, human)
Bio Products Laboratory, Ltd., a leading manufacturer of plasma-derived therapies, today announced that the U.S. Food and Drug Administration (FDA) ...
Posted by Michael Wonder on 05 Aug 2015
Seres Therapeutics receives FDA breakthrough therapy designation for its lead product candidate, SER-109
Seres Therapeutics, Inc., a leading microbiome therapeutics platform company, today announced that SER-109 (Firmacute Eubacterial Spores, Purified Suspension, Encapsulated), its ...