After a short delay and concerns of potential intervention from senior officials, the FDA has issued a draft guidance for the industry on the potential use of minimal residual disease (MRD) and ...
In certain cases, regulators will now be open to clearing therapies based on their ability to eliminate tumor cells, a change ...
The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...
The FDA issued draft guidance Jan. 21 proposing the use of minimal residual disease and complete response as primary endpoints to support accelerated approval of drugs for multiple myeloma. The draft ...
Inovio Pharmaceuticals faces an October 30 PDUFA date for INO-3107 with high regulatory risk and only a 5-7 month cash runway. Read why INO stock is a hold.
Clene is scheduled to meet with the FDA in the coming months to discuss new data for CNM-Au8, its experimental oral therapy ...
ImmunityBio (IBRX) shares added ~12% in the premarket on Wednesday after the Saudi Food and Drug Authority approved its ...
Inovio’s upside hinges on INO-3107 for HPV-6/11 RRP with FDA PDUFA Oct 2026, regulatory risk, tight cash, and cheap EV. Check ...
In patients naïve to HER2-targeted therapy, the objective response rate was 71% with a median duration of response of 9.2 months. The Food and Drug Administration (FDA) has granted accelerated ...
ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that the Saudi Food and Drug ...
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