pharmaphorum
JULY 6, 2022
The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? And how can regulators balance timely access with robust safety? They found that the FDA approved 85 (95%) of the drugs before the EMA, with the latter clocking up a median delay of 241 (150-370) days.
Pharmaceutical Technology
JUNE 19, 2023
UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. Novartis and Incyte Corp’s Jakafi was the first FDA-approved drug for the treatment of myelofibrosis in November 2011.
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Legacy MEDSearch
JANUARY 13, 2023
implantation of the HIT Reverse Hip Replacement System (Reverse HRS), under an FDA approved Investigational Device Exemption (IDE). The IDE Study is being conducted to determine the safety and effectiveness of the HIT Reverse HRS in Primary Total Hip Arthroplasty (THA). About Hip Innovation Technology, LLC. Are you hiring?
European Pharmaceutical Review
JANUARY 29, 2024
4 The use of CPCA assessments allows for the assignment of scientifically justifiable higher acceptable intakes (AIs), without impacting patient safety. During August 2023 the FDA also updated its guidance for NDSRIs 7 and it was closely aligned (but not identical) to EMA’s evolving guidance. ng/day, compared to EMA which is 18 ng/day.
World of DTC Marketing
FEBRUARY 4, 2021
regulators knew about reports of suicidal behavior in men taking the anti-baldness treatment Propecia when they decided not to warn consumers of those potential risks in a 2011 update of the popular drug’s label. The national vaccine safety surveillance program run by the Centers for Disease Control and Prevention (CDC) and the U.S.
Pharmaceutical Technology
NOVEMBER 14, 2022
In August 2021, Saphnelo, a type 1 interferon receptor antibody, became the first lupus treatment to be approved since GSK’s Benlyta (belimumab) won a regulatory nod in 2011. The] main the main issue is that there aren't that many sites in the US where MSCs can be produced in sufficient quantities in FDA-certified labs,” says Gilkeson.
Legacy MEDSearch
JULY 21, 2023
This first-in-female procedure was approved by the National Agency for the Safety of Medicines and Health Products (or ANSM, the French equivalent to the U.S. Food and Drug Administration (FDA) for UroActive. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States or in the EU.
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