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RSS FeedPosted by Michael Wonder on 18 Sep 2019
FDA grants breakthrough therapy designation for Roche’s Gazyva (obinutuzumab) in lupus nephritis
18 September 2019 - There are currently no U.S. FDA approved medicines for lupus nephritis. ...
Posted by Michael Wonder on 18 Sep 2019
Vertical Pharmaceuticals announces submission of new drug application for RVL-1201
17 September 2019 - Vertical Pharmaceuticals today announced the submission of a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 18 Sep 2019
U.S. FDA approves supplemental new drug application for Erleada (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer
17 September 2019 - Phase 3 TITAN is the first registrational study to achieve statistical significance in dual primary endpoints of ...
Posted by Michael Wonder on 17 Sep 2019
FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma
17 September 2019 - The U.S. FDA is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence. ...
Posted by Michael Wonder on 17 Sep 2019
FDA accepts Merck’s biologics license application and grants priority review for V920, the company’s investigational vaccine for Ebola Zaire virus
17 September 2019 - Merck continues to expand investigational supply to support international Ebola outbreak response. ...
Posted by Michael Wonder on 16 Sep 2019
FDA seeks input on product-specific guidances to facilitate generic drug development
16 September 2019 - Today, FDA published 53 product-specific guidances (PSGs) – 34 new guidances and 19 revised guidances, including ...
Posted by Michael Wonder on 16 Sep 2019
Verrica Pharmaceuticals submits new drug application to U.S. FDA for VP-102 for the treatment of molluscum contagiosum
16 September 2019 - No FDA approved treatments are currently available for this highly contagious, primarily paediatric, viral skin infection affecting ...
Posted by Michael Wonder on 16 Sep 2019
Wave Life Sciences announces fast track designation from U.S. FDA for suvodirsen
16 September 2019 - Suvodirsen is an investigational stereopure oligonucleotide in development for the treatment of DMD patients amenable to exon ...
Posted by Michael Wonder on 16 Sep 2019
Seattle Genetics and Astellas announce U.S. FDA grants priority review for enfortumab vedotin biologics license application in locally advanced or metastatic urothelial cancer
16 September 2019 - FDA sets Prescription Drug User Fee action date for 15 March 2020. ...
Posted by Michael Wonder on 16 Sep 2019
FDA grants fast track designation for Farxiga in heart failure
16 September 2019 - AstraZeneca today announced that the US FDA has granted fast track designation for the development of ...
Posted by Michael Wonder on 16 Sep 2019
Janssen submits application to U.S. FDA seeking first-in-class approval of Tremfya (guselkumab) for treatment of adults with active psoriatic arthritis
16 September 2019 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental biologics license ...
Posted by Michael Wonder on 15 Sep 2019
The startup that manipulated data to get a miracle drug to market
14 September 2019 - AveXis had a revolutionary gene therapy for babies with a deadly disease, and sold to Novartis for ...
Posted by Michael Wonder on 14 Sep 2019
U.S. officials worried about Chinese control of American drug supply
13 September 2019 - "Basically we've outsourced our entire industry to China," retired Brig. Gen. John Adams told NBC News. "That ...
Posted by Michael Wonder on 14 Sep 2019
Right to try ‘remains a bust,’ as many drug makers prefer FDA reviews
12 September 2019 - Despite the hubbub over the “right-to-try” law, a recent survey found that nearly half of drug ...
Posted by Michael Wonder on 14 Sep 2019
The U.S. health care system found a way to make peanuts cost $4,200
13 September 2019 - A new, billion-dollar pharmaceutical to treat peanut allergies is up for approval. It’s simply peanut flour. ...