Blog
RSS FeedPosted by Michael Wonder on 06 Mar 2019
Donald Trump just lost his most popular bureaucrat
6 March 2019 - U.S. FDA Commissioner Scott Gottlieb is resigning and will leave the agency in a month, according to ...
Posted by Michael Wonder on 06 Mar 2019
FDA chief tough on e-cigs steps down in surprise resignation
5 March 2019 - U.S. FDA Commissioner Scott Gottlieb said on Tuesday that he plans to step down next month, a ...
Posted by Michael Wonder on 06 Mar 2019
FDA grants rare paediatric disease designation to odiparcil for the treatment of MPS VI
5 March 2019 - Inventiva eligible to receive priority review voucher upon approval of odiparcil for the treatment of MPS VI. ...
Posted by Michael Wonder on 06 Mar 2019
U.S. FDA grants priority review for fedratinib new drug application in myelofibrosis
5 March 2019 - U.S. FDA sets Prescription Drug User Fee Act action date for 3 September 2019. ...
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
Lilly receives FDA priority review designation for Emgality (galcanezumab-gnlm) injection for the preventive treatment of episodic cluster headache in adults
5 March 2019 - Eli Lilly and Company announced today that the U.S. FDA has granted priority review for its ...
Posted by Michael Wonder on 05 Mar 2019
FDA is working to bridge gaps and meet needs for rare disease product development
28 February 2019 - There are approximately 7,000 rare diseases affecting an estimated 30 million people in the United States. ...
Posted by Michael Wonder on 05 Mar 2019
Stock price effects of breakthrough therapy designation
4 March 2019 - Since 2012, the FDA has awarded ‘breakthrough therapy designation’ to drug candidates in clinical development that ...
Posted by Michael Wonder on 05 Mar 2019
Moving upstream in anti-cancer drug development
4 March 2019 - The development of oncology drugs traditionally begins by studying them in heavily pretreated patients, and then working ...
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 05 Mar 2019
FDA grants rolling review for CytoDyn’s planned BLA for investigational HIV therapy leronlimab (PRO 140)
4 March 2019 - CytoDyn today announced that the FDA has reviewed and accepted CytoDyn’s request and plan to submit on ...
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 04 Mar 2019
Eli Lilly rolling out half-price insulin. Diabetics say it's not enough.
4 March 2019 - Eli Lilly said it plans to roll out a half-price version of its Humalog insulin, an ...
Posted by Michael Wonder on 04 Mar 2019
Intellipharmaceutics announces resubmission of new drug application to the U.S. FDA for its oxycodone ER
4 March 2019 - Intellipharmaceutics today announced that it has resubmitted its new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 04 Mar 2019
Lilly to introduce lower-priced insulin
4 March 2019 - Authorised generic version of Humalog will be available in U.S. pharmacies at 50 percent lower list price. ...