Blog
RSS FeedPosted by Michael Wonder on 10 Oct 2019
FDA cuts red tape in diagnosis applications for cancer trials
10 October 2019 - Drug companies developing cancer treatments can fold the risk assessment of unapproved screening tests into their ...
Posted by Michael Wonder on 10 Oct 2019
N-of-1 trials: FDA plots path to regulation
10 October 2019 - The US FDA is taking notice of a unique and recent phenomenon where physicians and specialists ...
Posted by Michael Wonder on 09 Oct 2019
Australian drug maker jumps 51% after winning FDA approval
9 October 2019 - Clinuvel Pharmaceuticals surged the most in five years after the U.S. FDA approved its treatment for ...
Posted by Michael Wonder on 09 Oct 2019
Vast Therapeutics receives qualified infectious disease product status for BIOC11
8 October 2019 - Vast Therapeutics today announced that another of its drug candidates, BIOC11, has been designated as a ...
Posted by Michael Wonder on 08 Oct 2019
FDA approves Octapharma’s Wilate for haemophilia A in adult and adolescent patients
8 October 2019 - Octapharma USA today announced the U.S. FDA has approved Wilate for treatment of adults and adolescents with ...
Posted by Michael Wonder on 08 Oct 2019
FDA accepts resubmitted new drug application for ITCA 650
8 October 2019 - Intarcia Therapeutics announced today that the U.S. FDA has accepted the company's resubmission of its new ...
Posted by Michael Wonder on 08 Oct 2019
HIV prevention drugs will be available without a prescription in California
7 October 2019 - California will expand access to HIV prevention drugs by allowing pharmacies to offer the medications without ...
Posted by Michael Wonder on 08 Oct 2019
FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases
8 October 2019 - The U.S. FDA today announced that it has awarded 12 new clinical trial research grants totaling ...
Posted by Michael Wonder on 08 Oct 2019
FDA approves first treatment to increase pain-free light exposure in patients with a rare disorder
8 October 2019 - The U.S. FDA today granted approval to Scenesse (afamelanotide) to increase pain-free light exposure in adult patients ...
Posted by Michael Wonder on 08 Oct 2019
Novartis receives FDA approval for Beovu, offering wet AMD patients vision gains and greater fluid reductions vs aflibercept
8 October 2019 - In two head-to-head clinical trials, patients on Beovu (brolucizumab) achieved vision gains that were non-inferior to ...
Posted by Michael Wonder on 08 Oct 2019
Waste in the US health care system: estimated costs and potential for savings
7 October 2019 - The United States spends more on health care than any other country, with costs approaching 18% of ...
Posted by Michael Wonder on 07 Oct 2019
Digital medicine movement is growing up and that’s a good thing
7 October 2019 - There has been a lot of hype about the digital transformation of health care. ...
Posted by Michael Wonder on 07 Oct 2019
Janssen submits application to U.S. FDA seeking approval of Stelera (ustekinumab) for the treatment of paediatric patients with moderate to severe plaque psoriasis
7 October 2019 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental biologics license ...
Posted by Michael Wonder on 07 Oct 2019
Mereo BioPharma receives FDA fast track designation for navicixizumab for the treatment of heavily pre-treated ovarian cancer
7 October 2019 - Mereo BioPharma today announces that the U.S. FDA has granted fast track designation to navicixizumab for the ...
Posted by Michael Wonder on 07 Oct 2019
Is FDA too lax with its drug approval standards? Senior FDA officials discuss.
7 October 2019 - From industry to academia, commenters have argued that the US FDA's drug approval standards are becoming ...