Blog
RSS FeedPosted by Michael Wonder on 05 Jul 2018
A risky drug approval lesson
4 July 2018 - What the FDA can learn from progress against muscular dystrophy. ...
Posted by Michael Wonder on 05 Jul 2018
Theratechnologies submits novel single-vial formulation of Egrifta (tesamorelin for injection) for FDA approval
4 July 2018 - Theratechnologies today announced that it has filed a supplemental new drug application with the FDA for ...
Posted by Michael Wonder on 04 Jul 2018
FDA approves Xeomin (incobotulinumtoxina) for adult patients with sialorrhoea
3 July 2018 - First and only neurotoxin approved for this indication in the United States. ...
Posted by Michael Wonder on 03 Jul 2018
Seeking to hire new talent, FDA hints it wants flexibility to pay more staff higher salaries
2 July 2018 - In a recent report to Congress, the FDA expressed gratitude for a 2016 law that enabled ...
Posted by Michael Wonder on 03 Jul 2018
Deloitte survey finds biopharma companies are accelerating adoption of real-world evidence
28 June 2018 - A recent survey shows that 90% of biopharma companies are making significant investments in real-world evidence ...
Posted by Michael Wonder on 03 Jul 2018
Cellerant Therapeutics announces FDA grants regenerative medicine advanced therapy designation for romyelocel-L to prevent infections during neutropenia
2 July 2018 - RMAT designation confers similar advantages as breakthrough therapy designation. ...
Posted by Michael Wonder on 02 Jul 2018
Fortress Biotech announces Cyprium Therapeutics’ CUTX-101 (copper histidinate) granted FDA fast track designation for treatment of classic Menkes disease
2 July 2018 - Fortress Biotech today announced that the U.S. FDA has granted fast track designation to Cyprium Therapeutics’ (“Cyprium”) ...
Posted by Michael Wonder on 02 Jul 2018
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) in combination with chemotherapy as first-line treatment for metastatic squamous non-small cell lung cancer
2 July 2018 - Application based on data from pivotal Phase 3 KEYNOTE-407 trial. ...
Posted by Michael Wonder on 02 Jul 2018
FDA approves Aristada Initio for the initiation of Aristada for schizophrenia
2 July 2018 - Novel regimen enables physicians to fully dose up to two months of Aristada treatment on day one. ...
Posted by Michael Wonder on 02 Jul 2018
Dermira receives FDA approval for Qbrexza (glycopyrronium) cloth to treat primary axillary hyperhidrosis
29 June 2018 - Qbrexza is expected to be available for prescribing in October 2018. ...
Posted by Michael Wonder on 02 Jul 2018
Acadia Pharmaceuticals announces FDA approval of new dosing formulation and strength for Nuplazid (pimavanserin)
29 June 2018 - New dosing formulation and strength address needs in treating patients with hallucinations and delusions associated with Parkinson’s ...
Posted by Michael Wonder on 02 Jul 2018
Ocular Therapeutix announces NDA resubmission of Dextenza
29 June 2018 - Ocular Therapeutix has announced the resubmission of the Company’s new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 01 Jul 2018
FDA allows off-label health care economic discussions. Is there more to come?
29 June 2018 - The Trump administration has issued final guidance that allows drug companies and device makers to provide ...
Posted by Michael Wonder on 28 Jun 2018
The biopharmaceutical industry provides 75% of the FDA's drug review budget. Is this a problem?
28 June 2018 - Caroline Chen of ProPublica has written a provocative article challenging the objectivity of the FDA in its ...
Posted by Michael Wonder on 28 Jun 2018
Statement from FDA Commissioner on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug
28 June 2018 - As a physician, I understand how important it can be for health care providers to treat ...