16 December 2022 - Ardelyx provided an update regarding the appeal to the complete response letter for the new drug ...
8 December 2022 - Hydroxyprogesterone caproate (Makena) is an injectable drug for the prevention of preterm birth, ie, birth prior to ...
9 December 2022 - The US FDA faces a persistent tension between confidence and speed. ...
9 December 2022 - Recent commentary reviewing the use of biologics or other novel molecules tested in the adjuvant setting for ...
2 December 2022 - Requirements for submitting bioavailability and bioequivalence data in investigational new drugs, new drug applications, abbreviated new drug ...
28 November 2022 - The US FDA recently published a report on how it uses modelling and simulation, highlighting the untapped ...
17 November 2022 - Makena highlights need to make system more nimble. ...
8 November 2022 - Decision denies Omeros’ appeal requesting immediate labeling discussions. ...
4 November 2022 - The US Supreme Court on Friday agreed to hear Amgen's bid to revive patents on its ...
27 October 2022 - Increasing the availability of safe and effective medicines for children is a key priority for the US ...
25 October 2022 - Last week’s overwhelming vote in favour of pulling preterm-birth drug Makena from the market — and ...
19 October 2022 - On Wednesday, the FDA advisory committee that oversees obstetrics, reproductive, and urologic drugs voted 14-1 that ...
19 October 2022 - In the rapidly changing landscape of digital health, innovation has often outpaced regulations, especially for novel ...
19 October 2022 - As announced in the Federal Register notice published on 20 October 2022, the FDA is conducting an ...
18 October 2022 - IntelGenx today announced that it has responded to the complete response letter for its 505(b)(2) new ...