Blog
RSS FeedPosted by Michael Wonder on 02 May 2018
Sandoz receives complete response letter from the US FDA for proposed biosimilar rituximab
2 May 2018 - Sandoz, a Novartis division, announced today that the US FDA has issued a complete response letter ...
Posted by Michael Wonder on 02 May 2018
FDA releases Theratechnologies from post-approval commitments related to Egrifta (tesamorelin for injection)
1 May 2018 - Theratechnologies today announced that the FDA has released Theratechnologies from post-approval commitments related to the approval ...
Posted by Michael Wonder on 01 May 2018
Acceleron receives FDA fast track designation for ACE-083 in facioscapulohumeral muscular dystrophy
1 May 2018 - Acceleron Pharma today announced that the U.S. FDA has granted fast track designation to ACE-083, a ...
Posted by Michael Wonder on 01 May 2018
Scynexis' oral SCY-078 receives FDA QIDP and fast track designations for the treatment of VVC and prevention of recurrent VVC
1 May 2018 - Enrollment completed in Phase 2b DOVE study in VVC; on-track for top-line data by July 2018. ...
Posted by Michael Wonder on 01 May 2018
Kymriah (tisagenlecleucel), first-in-class CAR-T therapy from Novartis, receives second FDA approval to treat appropriate r/r patients with large B-cell lymphoma
1 May 2018 - Kymriah is the only CAR-T therapy FDA-approved for two distinct indications - in non-Hodgkin lymphoma (NHL) and ...
Posted by Michael Wonder on 01 May 2018
FDA grants priority review to Merck’s sBLA for Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy based on results from Phase 3 KEYNOTE-189 trial as first-line treatment of metastatic non-squamous NSCLC
30 April 2018 - U.S. FDA has set a PDUFA date of 23 September 2018. ...
Posted by Michael Wonder on 01 May 2018
Actelion submits supplemental new drug application to US FDA seeking approval of Opsumit (macitentan) for the treatment of chronic thromboembolic pulmonary hypertension
30 April 2018 - Filing supported by data from MERIT-1 trial evaluating Opsumit in adults with inoperable CTEPH which showed significant ...
Posted by Michael Wonder on 01 May 2018
Starpharma completes US new drug application for VivaGel BV
30 April 2018 - VivaGel NDA covers two indications for bacterial vaginosis – treatment and prevention. ...
Posted by Michael Wonder on 30 Apr 2018
Novartis receives FDA approval of Tafinlar and Mekinist for adjuvant treatment of BRAF V600-mutant melanoma
30 April 2018 - New indication represents a new treatment option for patients in the US with BRAF mutation-positive melanoma at ...
Posted by Michael Wonder on 30 Apr 2018
FDA to conduct priority review of cemiplimab as a potential treatment for advanced cutaneous squamous cell carcinoma
30 April 2018 - The U.S. FDA has accepted priority review the biologics license application for cemiplimab for the treatment ...
Posted by Michael Wonder on 27 Apr 2018
The breakthrough therapy designation for promising cancer drugs is good for patients
27 April 2018 - One exciting component of the FDA Safety and Innovation Act was the creation of the breakthrough ...
Posted by Michael Wonder on 27 Apr 2018
FDA moves to encourage A.I. in medicine, drug development
26 April 2018 - It is establishing a new incubator focused on health technology. ...
Posted by Michael Wonder on 27 Apr 2018
FDA grants breakthrough therapy designation to Omeros’ MASP-2 inhibitor OMS721 for the treatment of high-risk haematopoietic stem cell transplant-associated thrombotic microangiopathy
26 April 2018 - Discussions on-going with FDA and European regulators for expedited approval. ...
Posted by Michael Wonder on 26 Apr 2018
Mission possible: moving the needle forward to advance health equity
26 April 2018 - Every April our country observes National Minority Health Month to spotlight what we’re doing to eliminate health ...
Posted by Michael Wonder on 26 Apr 2018
FDA grants fast track designation for OrphoMed’s ORP-101 for treatment of IBS-D
25 April 2018 - OrphoMed announced today that the U.S. FDA has granted fast track designation for the Company’s lead ...