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RSS FeedPosted by Michael Wonder on 30 May 2018
Celltrion completes resubmission for biosimilar candidate to FDA for review
30 May 2018 - U.S. FDA notified Celltrion of its re-inspection schedule regarding cGMP regular audit. ...
Posted by Michael Wonder on 30 May 2018
Accelerated approval of medicines: fit for purpose?
30 May 2018 - The uptake of a new medicine represents a balance between benefit–risk assessment and value considerations. In the ...
Posted by Michael Wonder on 30 May 2018
FDA approves new treatment for moderately to severely active ulcerative colitis
30 May 2018 - The U.S. FDA today expanded the approval of Xeljanz (tofacitinib) to include adults with moderately to severely ...
Posted by Michael Wonder on 30 May 2018
Statement from FDA Commissioner on the signing of the Right to Try Act
30 May 2018 - For patients with serious or immediately life-threatening diseases, the FDA remains committed to enhancing access to ...
Posted by Michael Wonder on 30 May 2018
As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion
30 May 2018 - Agency will work closely with selected applicants to accelerate product development. ...
Posted by Michael Wonder on 30 May 2018
Are big clinical trials relevant? Researchers disagree
29 May 2018 - Amid health care tailored to an individual’s DNA, do massive clinical trials that take years and involve ...
Posted by Michael Wonder on 30 May 2018
TrioxBio announces fast track designation granted by U.S. FDA to Raviten for the treatment of intradialytic hypotension
29 May 2018 - Phase II clinical trials in patients undergoing hemodialysis to be initiated in Q4, 2018. ...
Posted by Michael Wonder on 30 May 2018
Braeburn resubmits opioid use disorder drug CAM2038 for FDA consideration
28 May 2018 - Braeburn announces the resubmission of the new drug application for CAM2038, an investigational buprenorphine flexible-dose weekly and ...
Posted by Michael Wonder on 30 May 2018
Catalyst Pharmaceuticals announces FDA acceptance of NDA and priority review status for Firdapse (amifampridine phosphate) for Lambert-Eaton myasthenic syndrome
29 May 2018 - Catalyst Pharmaceuticals announced today that its new drug application for Firdapse for the treatment of Lambert-Eaton myasthenic ...
Posted by Michael Wonder on 30 May 2018
U.S. FDA grants priority review to Astellas’ new drug application for gilteritinib for the treatment of adult patients with relapsed or refractory acute myeloid leukaemia
29 May 2018 - Astellas announced today that the U.S. FDA has accepted, with priority review, the company’s new drug application ...
Posted by Michael Wonder on 29 May 2018
FDA accepts larotrectinib new drug application and grants priority review
29 May 2018 - PDUFA date set for 26 November 2018. ...
Posted by Michael Wonder on 29 May 2018
Pfizer's Xalkori (crizotinib) receives FDA breakthrough therapy designation in two new indications
29 May 2018 - Xalkori is the first tyrosine kinase inhibitor to receive breakthrough designation for the treatment of patients ...
Posted by Michael Wonder on 29 May 2018
Trump to sign 'right to try' bill next week
25 May 2018 - President Trump will sign legislation next week allowing terminally ill patients to access experimental drugs not ...
Posted by Michael Wonder on 29 May 2018
UCB announces the approval of Cimzia (certolizumab pegol) for moderate-to-severe plaque psoriasis, representing an important new option for patients in the U.S.
27 May 2018 - The U.S. FDA approval of Cimzia (certolizumab pegol) for use in moderate-to-severe plaque psoriasis marks the entry ...
Posted by Michael Wonder on 26 May 2018
The risks and benefits of expedited drug reviews
23 May 2018 - The US FDA oversees several programs that expedite approval of certain drugs that treat serious conditions ...