Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 19 Mar 2019
FDA approves Genentech’s Tecentriq in combination with chemotherapy for the initial treatment of adults with extensive-stage small cell lung cancer
18 March 2019 - First new initial treatment option approved by the U.S. FDA for people with ES-SCLC in more than ...
Posted by Michael Wonder on 18 Mar 2019
Allergan announces FDA approval of Avycaz (ceftazidime and avibactam) for paediatric patients
18 March 2019 - Label now includes new data on use of Avycaz for treatment of cUTI and cIAI in paediatric ...
Posted by Michael Wonder on 13 Mar 2019
Aerie Pharmaceuticals announces U.S. FDA approval of Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% for the reduction of intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension
12 March 2019 - Aerie Pharmaceuticals today announced that the U.S. FDA has approved Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% ...
Posted by Michael Wonder on 12 Mar 2019
FDA approves a new generic valsartan
12 March 2019 - Today, the U.S. FDA approved a new generic of Diovan (valsartan). ...
Posted by Michael Wonder on 12 Mar 2019
FDA approves Dupixent (dupilumab) for moderate-to-severe atopic dermatitis in adolescents
11 March 2019 - Only therapy that targets the IL-4/IL-13 pathway, a key driver of the allergic or type 2 inflammation ...
Posted by Michael Wonder on 12 Mar 2019
FDA allows first use of a novel cancer drug
4 September 2014 - The FDA on Thursday approved the first of an eagerly awaited new class of cancer drugs ...
Posted by Michael Wonder on 08 Mar 2019
FDA grants Genentech’s Tecentriq in combination with Abraxane accelerated approval for people with PD-L1-positive, metastatic triple-negative breast cancer
8 March 2019 - This Tecentriq combination is the first cancer immunotherapy regimen approved for breast cancer. ...
Posted by Michael Wonder on 06 Mar 2019
FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic
5 March 2019 - The U.S. FDA today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the ...
Posted by Michael Wonder on 05 Mar 2019
US FDA approves expanded Farxiga and Xigduo XR labels for use in patients with Type 2 diabetes and moderate renal impairment
27 February 2019 - Updated label confirms the well-established efficacy and safety profile for Farxiga and Xigduo XR. ...
Posted by Michael Wonder on 04 Mar 2019
Adlon Therapeutics announces FDA approval for Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII for the treatment of ADHD
1 March 2019 - In a simulated workplace environment study in adult patients with ADHD, Adhansia XR demonstrated statistically significant improvement ...
Posted by Michael Wonder on 28 Feb 2019
FDA approves Herceptin Hylecta for subcutaneous injection in certain HER2-positive breast cancers
28 February 2019 - Genentech today announced the U.S. FDA has approved Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) for subcutaneous injection for ...