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RSS FeedPosted by Michael Wonder on 14 Mar 2022
Incyte announces U.S. FDA has extended the supplemental new drug application review period for ruxolitinib cream (Opzelura) for the treatment of vitiligo
14 March 2022 - Incyte announced today that the U.S. FDA has extended the review period for the supplemental new ...
Posted by Michael Wonder on 14 Mar 2022
Corium receives FDA approval of Adlarity (donepezil transdermal system) for treatment of patients with Alzheimer's disease
14 March 2022 - First and only once weekly patch for convenient, well-tolerated delivery of most used drug for treatment of ...
Posted by Michael Wonder on 14 Mar 2022
Phathom Pharmaceuticals submits vonoprazan NDA to FDA for the treatment of erosive oesophagitis
14 March 2022 - Phathom Pharmaceuticals announced today that it has submitted a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 14 Mar 2022
Update on US regulatory review of Fasenra in chronic rhinosinusitis with nasal polyps
14 March 2022 - The US FDA has issued a complete response letter regarding the supplemental biologics license application for ...
Posted by Michael Wonder on 12 Mar 2022
Acadia Pharmaceuticals announces 4 August 2022 action date for resubmitted supplemental new drug application for Nuplazid (pimavanserin) for the treatment of Alzheimer’s disease psychosis
9 March 2022 - The FDA plans to hold an advisory committee meeting. ...
Posted by Michael Wonder on 12 Mar 2022
Biosimilar impact on oncology clinical trial design and operations
11 March 2022 - There is a wealth of data, reviews, articles, and regulatory guidance on how to conduct clinical trials ...
Posted by Michael Wonder on 12 Mar 2022
Myriad Genetics receives FDA approval of BRACAnalysis CDx as a companion diagnostic for Lynparza in early breast cancer
11 March 2022 - BRACAnalysis CDx is now the only germline test approved by FDA as a companion diagnostic for treatment ...
Posted by Michael Wonder on 11 Mar 2022
Lynparza approved in the US as adjuvant treatment for patients with germline BRCA mutated HER2 negative high risk early breast cancer
11 March 2022 - First and only approved medicine targeting BRCA mutations in early breast cancer. ...
Posted by Michael Wonder on 11 Mar 2022
Allogene Therapeutics receives FDA fast track designation for its first solid tumour candidate, ALLO-316 in the treatment of renal cell carcinoma
10 March 2022 - ALLO-316 is an allogeneic CAR T therapy candidate targeting CD70, which has broad potential application across a ...
Posted by Michael Wonder on 10 Mar 2022
Revance resubmits biologics license application for daxibotulinumtoxinA for injection for glabellar lines to the FDA
8 March 2022 - Revance Therapeutics today announced it has resubmitted its biologics license application to the U.S. FDA for DaxibotulinumtoxinA ...
Posted by Michael Wonder on 10 Mar 2022
Legislation would set expiration for FDA’s accelerated approvals
9 March 2022 - New legislation, introduced by a top Democrat in the House of Representatives, would codify the U.S. ...
Posted by Michael Wonder on 10 Mar 2022
When desperate patients go to court for unproven treatments - the battle for hospital independence
9 March 2022 - During the COVID-19 pandemic, patients have asked courts to compel hospitals to administer unproven therapies, including ivermectin. ...
Posted by Michael Wonder on 09 Mar 2022
Insightec receives FDA IDE approval and breakthrough designation for NSCLC brain mets study
9 March 2022 - Designation and approvals mark key milestones in advancing Insightec blood brain barrier clinical roadmap using acoustic ...
Posted by Michael Wonder on 09 Mar 2022
Bayer submits applications in the U.S. and EU for additional indication of Nubeqa (darolutamide)
9 March 2022 - Submissions are based on data from the pivotal Phase 3 ARASENS trial recently published in The New ...
Posted by Michael Wonder on 09 Mar 2022
More Government regulation of biopharma would harm patients and the economy
8 March 2022 - The United States leads the world in creating the new drugs and vaccines that cure or control ...