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RSS FeedPosted by Michael Wonder on 22 Nov 2018
FDA grants priority review for Daiichi Sankyo’s new drug application for FLT3 inhibitor quizartinib for treatment of patients with relapsed/refractory FLT3-ITD AML
22 November 2018 - Quizartinib marketing applications now under expedited review in the U.S., Japan and EU. ...
Posted by Michael Wonder on 21 Nov 2018
IntelGenx announces FDA’s acceptance of resubmission of new drug application for Rizaport
20 November 2018 - PDUFA goal date of 1 April 2019. ...
Posted by Michael Wonder on 21 Nov 2018
ImmunoMolecular Therapeutics awarded SBIR grant and receives rare paediatric disease designation from FDA for IMT-002
14 November 2018 - Rare paediatric disease designation granted to IMT-002 for type 1 diabetes. ...
Posted by Michael Wonder on 21 Nov 2018
AbbVie receives US FDA accelerated approval for Venclexta (venetoclax) for treatment of newly-diagnosed acute myeloid leukaemia patients ineligible for intensive chemotherapy
21 November 2018 - The approval in AML is the third provided under priority review by the U.S. FDA for Venclexta, ...
Posted by Michael Wonder on 21 Nov 2018
FDA approves new treatment for patients with acute myeloid leukaemia
21 November 2018 - The U.S. FDA today approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine, for ...
Posted by Michael Wonder on 21 Nov 2018
GSK submits US regulatory filing to expand the use of Nucala in children with severe eosinophilic asthma
19 November 2018 - GSK today announced the filing of a supplemental biologics license application to the US FDA seeking ...
Posted by Michael Wonder on 20 Nov 2018
FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease
20 November 2018 - The U.S. FDA today approved Gamifant (emapalumab) for the treatment of paediatric (newborn and above) and ...
Posted by Michael Wonder on 19 Nov 2018
Gottlieb pushes for funding to speed gene therapy reviews
16 November 2018 - The FDA is working to increase its investment in reviewing gene therapy products, Commissioner Scott Gottlieb ...
Posted by Michael Wonder on 18 Nov 2018
Aquestive Therapeutics receives complete response letter from U.S. FDA for tadalafil oral film
16 November 2018 - Aquestive Therapeutics today announced it received a complete response letter from the U.S. FDA in regards to ...
Posted by Michael Wonder on 17 Nov 2018
FDA approves Novartis drug Promacta for first-line SAA and grants breakthrough therapy designation for additional new indication
16 November 2018 - Promacta receives FDA approval for first-line treatment of severe aplastic anaemia and breakthrough therapy designation for low ...
Posted by Michael Wonder on 17 Nov 2018
FDA approves new drug to treat travelers’ diarrhoea
16 November 2018 - The U.S. FDA today approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients ...
Posted by Michael Wonder on 16 Nov 2018
Statement by FDA Commissioner Scott Gottlieb on the FDA’s efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs
16 November 2018 - The FDA remains committed to ensuring that FDA-approved drugs are safe and effective for Americans. As ...
Posted by Michael Wonder on 16 Nov 2018
FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot
16 November 2018 - The U.S. FDA today expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy ...
Posted by Michael Wonder on 16 Nov 2018
FDA grants breakthrough therapy designation to Adcetris (brentuximab vedotin) for frontline peripheral T-cell lymphomas
15 November 2018 - Designation based on positive Phase 3 ECHELON-2 Trial evaluating Adcetris in frontline CD30-expressing peripheral T-cell lymphomas. ...
Posted by Michael Wonder on 15 Nov 2018
FDA official hints at a tough road ahead for ‘right to try’
14 November 2018 - A top FDA official seemed to suggest that the new “right-to-try” law, which skirts around the ...