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RSS FeedPosted by Michael Wonder on 09 Aug 2018
Americans fund most of the world’s drug research. Here’s how Trump can end that.
9 August 2018 - President Donald Trump recently released an ambitious, 44-page plan to drive down prescription drug prices. The ...
Posted by Michael Wonder on 09 Aug 2018
Sesen Bio announces Vicinium granted fast track designation by FDA for treatment of non-muscle invasive bladder cancer
9 August 2018 - Sesen Bio today announced that the U.S. FDA has granted fast track designation to Vicinium for the ...
Posted by Michael Wonder on 09 Aug 2018
Glenmark Pharmaceuticals announces FDA acceptance of the company's first new drug application for Ryaltris for patients with seasonal allergic rhinitis
7 August 2018 - The PDUFA target action date for completion of the FDA review is 21 March 2019. ...
Posted by Michael Wonder on 09 Aug 2018
Genmab announces submission of U.S. & EU regulatory applications seeking approval of Darzalex (daratumumab) split dosing regimen
8 August 2018 - Applications seek to update prescribing information and summary of product characteristics. ...
Posted by Michael Wonder on 08 Aug 2018
FDA approves treatment for two rare types of non-Hodgkin lymphoma
8 August 2018 - The U.S. FDA today approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients ...
Posted by Michael Wonder on 08 Aug 2018
FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs
8 August 2018 - The U.S. FDA today approved several strengths of potassium chloride oral solution as the first generic drugs ...
Posted by Michael Wonder on 08 Aug 2018
The FDA is poised to approve the first-ever drug that mutes disease-causing genes
7 August 2018 - After a decades-long wait, the FDA is on the brink of approving a landmark rare disease ...
Posted by Michael Wonder on 08 Aug 2018
Patient reported outcome measures in the FDA pilot compendium: meeting today’s standards for patient engagement in development?
7 August 2018 - In 2016, the FDA released a pilot clinical outcome assessment compendium intended to foster patient-focused drug development. ...
Posted by Michael Wonder on 07 Aug 2018
Nohla Therapeutics receives FDA fast track designation for dilanubicel for allogeneic cord blood transplant patients
6 August 2018 - Nohla Therapeutics today announced that the U.S. FDA has granted fast track designation to dilanubicel (NLA101) for ...
Posted by Michael Wonder on 07 Aug 2018
FDA approves Orkambi (lumacaftor/ivacaftor) as first medicine to treat the underlying cause of cystic fibrosis for children ages 2-5 years with most common form of the disease
7 August 2018 - Approximately 1,300 people in the U.S. ages 2 through 5 years have two copies of the F508del ...
Posted by Michael Wonder on 07 Aug 2018
Array Biopharma receives FDA breakthrough therapy designation for Braftovi in combination with Mektovi and cetuximab for BRAF V600E mutant metastatic colorectal cancer
7 August 2018 - Designation based on Phase 3 BEACON CRC safety lead-in data. ...
Posted by Michael Wonder on 06 Aug 2018
Karyopharm completes rolling submission of new drug application to U.S. FDA for selinexor as a treatment for patients with penta-refractory multiple myeloma
6 August 2018 - Selinexor has received both orphan drug and fast track designations from the FDA for this indication. ...
Posted by Michael Wonder on 06 Aug 2018
FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder
6 August 2018 - The U.S. FDA today issued new scientific recommendations aimed at encouraging more widespread innovation and development of ...
Posted by Michael Wonder on 06 Aug 2018
Complete response letter issued for Remoxy
6 August 2018 - Pain Therapeutics today announced it had received a complete response letter from the U.S. FDA for its ...
Posted by Michael Wonder on 06 Aug 2018
U.S. FDA grants fast track designation for BioCryst’s BCX7353
6 August 2018 - BioCryst Pharmaceuticals today announced that the Company has been granted fast track designation by the U.S. ...