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RSS FeedPosted 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 ...
Posted by Michael Wonder on 09 Mar 2022
7 Hills Pharma’s clinical stage novel immunostimulant 7HP349 granted FDA fast track designation for anti-PD-1 resistant metastatic melanoma
8 March 2022 - 7 Hills Pharma announced today that the U.S. FDA has granted fast track designation to 7HP349, 7HP’s ...
Posted by Michael Wonder on 08 Mar 2022
Vaccine approval before Phase 3 trial results: a consequence of vaccine access inequity
2 March 2022 - The final Phase 3 clinical data for CanSino Biologics' adenovirus type 5 vector vaccine show that Ad5-nCoV ...
Posted by Michael Wonder on 08 Mar 2022
Saluda Medical receives FDA approval for the Evoke spinal cord stimulation system to treat chronic intractable pain
8 March 2022 - Evoke system deemed superior to open loop spinal cord stimulation in treating overall back and leg pain. ...
Posted by Michael Wonder on 08 Mar 2022
FDA effort to improve clinical trial diversity failed to make a difference for Black patients, study finds
7 March 2022 - Six years ago, the U.S. FDA launched a five year action plan to improve the diversity and ...
Posted by Michael Wonder on 08 Mar 2022
FDA offers funding for biosimilar regulatory science pilot
7 March 2022 - The US FDA is offering funding for several research proposals under the regulatory science pilot for ...
Posted by Michael Wonder on 07 Mar 2022
TGA approves Sogroya
8 March 2022 - Somapacitan is a long‑acting recombinant human growth hormone derivative. ...
Posted by Michael Wonder on 07 Mar 2022
Merit Medical receives FDA breakthrough device designation for Embosphere microspheres for use in genicular artery embolisation for symptomatic knee osteoarthritis
7 March 2022 - Merit Medical Systems announced today that it has received breakthrough device designation from the U.S. FDA ...
Posted by Michael Wonder on 07 Mar 2022
Key Democrat moves to crack down on FDA accelerated approvals
7 March 2022 - A powerful Democratic lawmaker has introduced a bill that would dramatically rein in the Food and ...
Posted by Michael Wonder on 07 Mar 2022
Teva announces launch of a first generic version of Revlimid (lenalidomide capsules) in the U.S.
7 March 2022 - Teva Pharmaceuticals announced today the launch of a first generic version of Revlimid (lenalidomide capsules), in 5 ...
Posted by Michael Wonder on 07 Mar 2022
Novavax’s Covid-19 vaccine moves closer to FDA authorisation decision
6 March 2022 - Company says it has resolved manufacturing problems that led to earlier delays; FDA is reviewing shot’s authorisation ...
Posted by Michael Wonder on 07 Mar 2022
Horizon Therapeutics announces FDA has granted priority review of the supplemental biologics license application for the concomitant use of Krystexxa (pegloticase injection) plus methotrexate for people living with uncontrolled gout
7 March 2022 - Application based on recent MIRROR randomised controlled trial results, which showed 71% of patients randomised to ...
Posted by Michael Wonder on 07 Mar 2022
Servier announces FDA filing acceptance and priority review for Tibsovo (ivosidenib tablets) in combination with azacitidine for patients with previously untreated IDH1 mutated acute myeloid leukaemia
7 March 2022 - sNDA based on data from the global, Phase 3, AGILE trial evaluating Tibsovo in combination with ...