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RSS FeedPosted by Michael Wonder on 05 Dec 2019
FDA approves first generics of Gilenya
5 December 2019 - The U.S. FDA has approved three applications for first generics of Gilenya (fingolimod) capsules for the ...
Posted by Michael Wonder on 05 Dec 2019
FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases
5 December 2019 - The U.S. FDA today announced the global launch of CURE ID, an internet-based repository that will allow ...
Posted by Michael Wonder on 05 Dec 2019
ViiV Healthcare submits new drug application to the FDA for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available
5 December 2019 - ViiV Healthcare today completed submission of a new drug application to the US FDA seeking approval of ...
Posted by Michael Wonder on 05 Dec 2019
FDA declines to approve Enzyvant regenerative therapy on manufacturing concerns
6 December 2019 - Privately held drug developer Enzyvant said on Thursday the U.S. FDA declined to approve its regenerative ...
Posted by Michael Wonder on 05 Dec 2019
FDA authorises marketing of diagnostic test that uses novel technology to detect MRSA bacteria
5 December 2019 - Today, the U.S. FDA authorised marketing of a new diagnostic test based on bacterial viability and novel ...
Posted by Michael Wonder on 04 Dec 2019
ImmunityBio granted FDA breakthrough therapy designation for N-803 IL-15 superagonist in non-muscle invasive bladder cancer
4 December 2019 - Results of Phase 1 and 2 studies in BCG unresponsive non-muscle invasive bladder cancer in high risk ...
Posted by Michael Wonder on 04 Dec 2019
Bristol-Myers Squibb announces U.S. FDA breakthrough therapy designation for Orencia (abatacept) to help prevent acute graft-versus-host disease, a potentially life-threatening complication after stem cell transplant
4 December 2019 - Bristol-Myers Squibb today announced that the U.S. FDA has granted breakthrough therapy designation for Orencia (abatacept) ...
Posted by Michael Wonder on 04 Dec 2019
FDA nominee clears Senate panel
3 December 2019 - A Senate committee on Tuesday advanced the nomination of Dr. Stephen Hahn, a noted oncologist and ...
Posted by Michael Wonder on 04 Dec 2019
BridgeBio Pharma’s Origin Biosciences initiates rolling submission of new drug application with the U.S. FDA for BBP-870 for the treatment of MoCD type A
3 December 2019 - BridgeBio Pharma subsidiary Origin Biosciences has initiated a rolling submission of a NDA with the United ...
Posted by Michael Wonder on 04 Dec 2019
Immunomedics resubmits biologics license application to the FDA for sacituzumab govitecan
3 December 2019 - Immunomedics today announced the resubmission of its biologics license application to the U.S. FDA seeking accelerated ...
Posted by Michael Wonder on 04 Dec 2019
FDA approves Genentech’s Tecentriq plus chemotherapy (Abraxane and carboplatin) for the initial treatment of metastatic non-squamous non-small cell lung cancer
3 December 2019 - Approval based on the Phase III IMpower130 study showing the Tecentriq plus chemotherapy combination demonstrated a significant ...
Posted by Michael Wonder on 03 Dec 2019
Regenerative medicine advanced therapy designation granted by FDA to ADP‑A2M4 for the treatment of synovial sarcoma
3 December 2019 - Will enable expedited development and review of ADP-A2M4 with the goal of commercialisation in 2022 for patients ...
Posted by Michael Wonder on 03 Dec 2019
Trends in the price per median and mean life-year gained among newly approved cancer therapies 1995 to 2017
2 December 2019 - The prices of newly approved cancer drugs have risen over the past decades. ...
Posted by Michael Wonder on 03 Dec 2019
Aquestive Therapeutics completes rolling submission of new drug application to U.S. Food and Drug Administration for Libervant (diazepam) buccal film for management of seizure clusters
2 December 2019 - Aquestive Therapeutics today announced the completion, as planned, of the rolling submission of a new drug ...
Posted by Michael Wonder on 03 Dec 2019
Clarifying the meaning of clinically meaningful benefit in clinical research: noticeable change vs valuable change
2 December 2019 - Recent years have witnessed an increasing focus on the input of patients, their caregivers, or both to ...