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RSS FeedPosted by Michael Wonder on 25 Feb 2019
FDA approves Taiho Oncology's Lonsulf (trifluridine/tipiracil) for adult patients with previously treated advanced gastric or gastro-esophageal junction (GEJ) Adenocarcinoma
25 February 2019 - Taiho Oncology today announced that the United States FDA has approved Lonsulf as a treatment for adult ...
Posted by Michael Wonder on 21 Feb 2019
Indivior launches generic version of its Suboxone opioid drug
20 February 2019 - British drugmaker Indivior said on Wednesday it had launched a copycat version of its blockbuster opioid ...
Posted by Michael Wonder on 20 Feb 2019
Novo Nordisk receives US FDA approval of Esperoct (turoctocog alfa pegol, N8-GP)
19 February 2019 - Novo Nordisk today announced that the US FDA has approved the biologics license application for Esperoct ...
Posted by Michael Wonder on 20 Feb 2019
FDA approves Merck’s Keytruda (pembrolizumab) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection
19 February 2019 - U.S. approval based on significant recurrence-free survival benefit demonstrated with Keytruda in Phase 3 EORTC1325/KEYNOTE-054 trial. ...
Posted by Michael Wonder on 15 Feb 2019
FDA authorises first interoperable insulin pump intended to allow patients to customise treatment through their individual diabetes management devices
14 February 2019 - The U.S. FDA today permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable ...
Posted by Michael Wonder on 14 Feb 2019
Motif Bio receives complete response letter from the FDA
14 February 2019 - Motif Bio announced today that the Company has received a complete response letter from the U.S. FDA ...
Posted by Michael Wonder on 14 Feb 2019
Novartis receives FDA approval for Egaten for the treatment of fascioliasis, a neglected tropical disease
13 February 2019 - Egaten is the only drug approved in the US for the treatment of people with fascioliasis and ...
Posted by Michael Wonder on 13 Feb 2019
Mylan launches Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder), at a list price 70% less than the brand
12 February 2019 - Unique pricing of Wixela Inhub immediately benefits patients and reduces overall cost to the U.S. health care ...
Posted by Michael Wonder on 13 Feb 2019
Genmab announces U.S. FDA approval of Darzalex (daratumumab) split dosing regimen
12 February 2019 - Provides healthcare professionals with option to split first Darzalex infusion over two consecutive days. ...
Posted by Michael Wonder on 08 Feb 2019
Generic drug approvals surge, but hundreds still aren't for sale
7 February 2019 - The Trump administration has been trumpeting a huge increase in FDA generic drug approvals the past ...
Posted by Michael Wonder on 06 Feb 2019
FDA approves first therapy for the treatment of adult patients with a rare blood clotting disorder
6 February 2019 - The U.S. FDA today approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma ...
Posted by Michael Wonder on 05 Feb 2019
Pain Therapeutics announces feedback from recent meeting with FDA on Remoxy
5 February 2019 - Going Forward, We Will Be Silent Regarding Future Expectations for REMOXY. ...
Posted by Michael Wonder on 04 Feb 2019
Evolus receives FDA approval for Jeuveau prabotulinumtoxina-xvfs for injection
1 February 2019 - Jeuveau is the first aesthetic-only neurotoxin approved in the U.S; launch planned for spring 2019. ...
Posted by Michael Wonder on 04 Feb 2019
Alkermes receives complete response letter from U.S. FDA for ALKS 5461 new drug application
1 February 2019 - Alkermes today announced that it received a complete response letter from the U.S. FDA regarding its ...
Posted by Michael Wonder on 01 Feb 2019
Sunovion receives complete response letter from FDA for apomorphine sublingual film (APL-130277)
30 January 2019 - Sunovion Pharmaceuticals announced today that the U.S. FDA issued a complete response letter for the new ...