Dr Reddy`s Generic Midostaurin Receives Approval in US
Lotus's Generic Midostaurin Receives Approval in the U.S.
The National Institute for Health and Care Excellence, the United Kingdom’s watchdog on the value of drugs, issued draft guidance recommending Novartis’ midostaurin to treat advanced systemic mastocytosis in adults.
In draft guidance published today (19 August 2021), NICE has recommended midostaurin (Rydapt, Novartis) as a treatment for advanced systemic mastocytosis in adults.
Blueprint challenges Novartis with new Ayvakit nod
Less than a year after scoring a fast FDA OK for its pioneering acute myeloid leukemia drug gilteritinib, Astellas has snapped up a positive recommendation from European regulators following an accelerated assessment.
The US Food and Drug Administration (FDA) on Thursday issued a batch of 54 new and revised product-specific draft guidances detailing its expectations for companies looking to develop generic versions of those products.
Daiichi Sankyo execs just gained an added edge for their upcoming discussions with the FDA on an application to start selling quizartinib, a new drug for treatment-resistant acute myeloid leukemia with FLT3-ITD mutations.
Once an application has been accepted for evaluation by TGA, the approval time is defined as the number of TGA working days between commencement of evaluation and registration decision. TGA works to business target timeframes as well as to legislated timeframes for each category of application. Approval times are underpinned by legislation (see Therapeutic Goods Regulations 1990) and excludes public holidays, weekends, the time allocated to the sponsor to respond to requests for information, 'mutual clock stop' periods agreed with the sponsor, or other review activities.