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New CBER director Vinay Prasad defends his past criticisms of vaccines and says he is not anti-vax and promises that the Center wi...[ Price : $8.95]
FDA grants MeiraGTx Holdings a regenerative medicine advanced therapy designation for gene therapy AAV-GAD and its use for treatin...[ Price : $8.95]
FDA prepares to begin negotiation sessions in September to reauthorize the Prescription Drug User Fee Act, which expires 9/2027.[ Price : $8.95]
FDA commissioner Marty Makary says discussions are continuing with Novavax on its BLA to convert a 2022 emergency use authorizatio...[ Price : $8.95]
Paradigm Therapeutics plans an NDA submission in the second half of this year for Zorblisa (SD-101), as a topical whole-body treat...[ Price : $8.95]
FDA approves a Teal Health PMA for the Teal Wand, the first at-home vaginal sample, self-collection device for cervical cancer scr...[ Price : $8.95]
FDA again misses a user fee review action decision in the wake of mass staff cuts, the third miss in a month this time it's a GSK...[ Price : $8.95]
Speakers at the DTC National conference suggest a ban on drug DTC ads is not very likely.