Blog
RSS FeedPosted by Michael Wonder on 15 Mar 2020
For second time, FDA rejects Intarcia's diabetes implant
11 March 2020 - Boston-based Intarcia continues to run into a regulatory roadblock concerning its implanted diabetic pump ITCA 650. ...
Posted by Michael Wonder on 11 Mar 2020
U.S. FDA approves Opdivo (nivolumab) + Yervoy (ipilimumab) for patients with hepatocellular carcinoma previously treated with sorafenib
11 March 2020 - Opdivo + Yervoy is the first and only dual immunotherapy approved in this setting. ...
Posted by Michael Wonder on 09 Mar 2020
FDA approves first treatment for group of progressive interstitial lung diseases
9 March 2020 - The U.S. FDA today approved Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing interstitial lung ...
Posted by Michael Wonder on 07 Mar 2020
FDA approves new treatment for adults with Cushing’s disease
6 March 2020 - The U.S. FDA today approved Isturisa (osilodrostat) oral tablets for adults with Cushing’s disease who either cannot ...
Posted by Michael Wonder on 05 Mar 2020
Allergan receives FDA approval for Durysta (bimatoprost implant) the first and only intracameral biodegradable sustained-release implant to lower intra-ocular pressure in open-angle glaucoma or ocular hypertension patients
5 March 2020 - Durysta lowered intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension by approximately 30% from baseline ...
Posted by Michael Wonder on 03 Mar 2020
Sebela Pharmaceuticals announces FDA approval of Pizensy for oral solution for the treatment of chronic idiopathic constipation in adults
2 March 2020 - Sebela seeks partner to commercialise in the U.S. ...
Posted by Michael Wonder on 02 Mar 2020
FDA approves new therapy for patients with previously treated multiple myeloma
2 March 2020 - Today, the U.S. FDA approved Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone, for the treatment of ...
Posted by Michael Wonder on 29 Feb 2020
FDA approves first generic of Daraprim
28 February 2020 - Agency continues to support competition in generic drugs, increasing patient access to more affordable medicines. ...
Posted by Michael Wonder on 28 Feb 2020
Acacia Pharma announces US approval of Barhemsys (amisulpride) for the treatment and prevention of PONV
27 February 2020 - Barhemsys is the first and only antiemetic to be approved for the rescue treatment of PONV ...
Posted by Michael Wonder on 28 Feb 2020
Biohaven's Nurtec ODT (rimegapant) receives FDA approval for the acute treatment of migraine in adults
27 February 2020 - First and only calcitonin gene-related peptide receptor antagonist available in a fast-acting orally disintegrating tablet. ...
Posted by Michael Wonder on 26 Feb 2020
Puma Biotechnology receives U.S. FDA approval of supplemental new drug application for neratinib to treat HER2-positive metastatic breast cancer
26 February 2020 - Puma Biotechnology announced that the U.S. FDA approved a supplemental new drug application for neratinib in combination ...
Posted by Michael Wonder on 25 Feb 2020
Perrigo and Catalent announce FDA approval of Perrigo's AB-rated generic version of ProAir HFA
24 February 2020 - Perrigo and its partner, Catalent Pharma Solutions, today announced that the U.S. FDA has approved Perrigo's abbreviated ...
Posted by Michael Wonder on 25 Feb 2020
FDA approves first generic of ProAir HFA
24 February 2020 - Agency supports development of complex generic drugs to improve competition and access to more affordable medicines. ...
Posted by Michael Wonder on 24 Feb 2020
Seqirus receives FDA approval for Fluad Quadrivalent (influenza vaccine, adjuvanted) for adults 65 years and older
24 February 2020 - Designed with MF59 adjuvant to help strengthen, broaden and lengthen the body's immune response against the influenza ...
Posted by Michael Wonder on 24 Feb 2020
Teva announces FDA approval of ArmonAir Digihaler (fluticasone propionate) inhalation powder
24 February 2020 - Teva’s digital inhaler portfolio now includes products from three of the most commonly prescribed classes of ...