Blog
RSS FeedPosted by Michael Wonder on 09 Dec 2019
FDA approving drugs at breakneck speed, raising alarm
7 December 2019 - Breakthrough products beating deadlines by weeks, even months. ...
Posted by Michael Wonder on 09 Dec 2019
Court rules against FDA’s finding that a device was a drug
9 December 2019 - Whether the US FDA classifies a product as a drug or a device can have huge ...
Posted by Michael Wonder on 07 Dec 2019
Janssen announces BCMA CAR-T therapy JNJ-4528 granted U.S. FDA breakthrough therapy designation for the treatment of relapsed or refractory multiple myeloma
6 December 2019 - Newest designation for JNJ-4528 is supported by Phase 1b/2 CARTITUDE-1 study in adults with relapsed or refractory ...
Posted by Michael Wonder on 06 Dec 2019
FDA approves Amgen's Avsola (infliximab-axxq), for the same indications as Remicade (infliximab)
6 December 2019 - Amgen's fourth FDA approval from biosimilars portfolio. ...
Posted by Michael Wonder on 06 Dec 2019
Alector announces FDA fast track designation granted to AL001 for the treatment of patients with frontotemporal dementia
5 December 2019 - Alector today announced that the U.S. FDA has granted fast track designation for its investigational therapeutic, ...
Posted 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 ...