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RSS FeedPosted by Michael Wonder on 18 Dec 2018
UroGen Pharma initiates rolling submission of new drug application for UGN-101 for the treatment of low-grade upper tract urothelial cancer
17 December 2018 - Company expects to complete submission by mid-2019, with potential approval in 2019. ...
Posted by Michael Wonder on 18 Dec 2018
FDA approves Shire’s Motegrity (prucalopride), the only serotonin-4 receptor agonist for adults with chronic idiopathic constipation
17 December 2018 - Unlike other prescription chronic idiopathic constipation treatments, Motegrity works differently by enhancing natural movements of the colon ...
Posted by Michael Wonder on 18 Dec 2018
Alkermes and Biogen announce submission of a new drug application to U.S. FDA for diroximel fumarate in multiple sclerosis
17 December 2018 - Alkermes and Biogen today announced that Alkermes has submitted a new drug application to the U.S. ...
Posted by Michael Wonder on 17 Dec 2018
Eiger announces breakthrough therapy designation granted by FDA for lonafarnib for treatment of hepatitis delta virus infection
17 December 2018 - Phase 3 HDV “D-LIVR” international study initiating. ...
Posted by Michael Wonder on 17 Dec 2018
Amgen submits biologics license application for ABP 710 (biosimilar infliximab) to US Food And Drug Administration
17 December 2018 - Filing for ABP 710, a biosimilar candidate to infliximab, supported by Phase 3 study in patients with ...
Posted by Michael Wonder on 16 Dec 2018
A drug that was once inexpensive gets a new price tag: $375,000
13 December 2018 - An old, formerly inexpensive drug called Firdapse was just slapped with a steep new price tag: ...
Posted by Michael Wonder on 15 Dec 2018
Supernus announces FDA approval of sNDA to expand Oxtellar XR label to include monotherapy
14 December 2018 - Supernus Pharmaceuticals announced today that the United States FDA has approved the Company’s supplemental new drug ...
Posted by Michael Wonder on 15 Dec 2018
Celltrion and Teva announce FDA approval of Herzuma (trastuzumab-pkrb), a biosimilar to Herceptin, for the treatment of HER2-over-expressing breast cancer for certain indications
15 December 2018 - Celltrion and Teva Pharmaceutical Industries today announced that the U.S. FDA has approved Herzuma (trastuzumab-pkrb), a ...
Posted by Michael Wonder on 15 Dec 2018
FDA approves Nplate (romiplostim) for use in paediatric patients with immune thrombocytopenia
14 December 2018 - Application granted priority review designation. ...
Posted by Michael Wonder on 13 Dec 2018
A method for approximating future entry of generic drugs
13 December 2018 - The paper by Beall and colleagues relates to the development and testing of a method for approximating ...
Posted by Michael Wonder on 13 Dec 2018
Statement from FDA Commissioner and Director of FDA’s Center for Drug Evaluation and Research on efforts to modernise generic drug labels while maintaining the efficiency of generic development
13 December 2018 - Protecting patient safety is at the core of the FDA’s mission. All FDA-approved drugs have benefits and ...
Posted by Michael Wonder on 13 Dec 2018
FDA grants fast track designation to the baricitinib development program for the treatment of systemic lupus erythematosus
13 December 2018 - Eli Lilly and Incyte announced today that the U.S. FDA has granted fast track designation to ...
Posted by Michael Wonder on 13 Dec 2018
Authorized generic for Evzio (naloxone hydrochloride injection) to be available at a reduced list price of $178
12 December 2018 - Product will be available in 2019. ...
Posted by Michael Wonder on 12 Dec 2018
Mallinckrodt's SpecGx receives FDA complete response letter for abuse-deterrent, immediate-release reformulation of Roxicodone (oxycodone hydrochloride)
12 December 2018 - SpecGx announced today that it has received a complete response letter from the U.S. FDA related ...
Posted by Michael Wonder on 12 Dec 2018
FDA takes aim at pharma’s biosimilar-delaying tactics
12 December 2018 - Ever-rising cost of insulins also to be targeted. ...