JD Supra

Conditional Approval Proposals for FDA: Current Context and Potential Ramifications

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global marketplace, the drug approval standard employed by FDA remains a ...
Healthcare Dive

FDA sets stricter approval standards for COVID vaccines

The Food and Drug Administration is changing how it reviews new COVID-19 vaccines, setting out stricter standards in place of the framework it used to quickly clear updated boosters for all adults the ...
Yahoo

Congress reacts to House approval of budget framework for Trump’s ‘big’ bill

House Republicans narrowly approved their budget framework Thursday, a political turnaround after Speaker Mike Johnson worked into the night to satisfy GOP holdouts who had refused to advance ...
Hosted on MSN

ProKidney Shares Dip Following FDA Agreement on Rilparencel Approval Strategy

ProKidney Corp. (NASDAQ:PROK) saw its stock drop 11% in early trading before recovering somewhat to close down 3%, after announcing alignment with the U.S. Food and Drug Administration on the ...
JD Supra

Major Overhaul of UK Rare Disease Regulation: MHRA Proposes Enhanced Framework

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced its intention to introduce sweeping reforms for accelerating rare disease therapy development and approval, with the aim ...