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Mar 5, 2026 · But the agency has increasingly issued drugrejections or refusals — about 20 in the last eight months — that underscore a break from decades of general stability in the F.D.A.’s top...
Mar 5, 2026 · Former agency officials rejected their share of newdrugs, upholding standards that caused drugmakers to abandon many therapies. But in interviews, they defended their overall record.
Mar 5, 2026 · The FDA under the current administration has tightened the gate on new rare-disease drugs, prompting anxiety among families who depend on experimental therapies as denials mount after an initial period o...
Mar 5, 2026 · Agency officials promise fast reviews of new treatments while vowing they will not be a “rubber stamp” for the industry. But patients with rare diseases view recent decisions as signs that the doors are ...
Mar 5, 2026 · A recent New York Times article highlights ongoing discussions about how the FDA evaluates and approves treatments for rare diseases, and how federal health policy decisions could impact the pace of drug...
Mar 3, 2026 · The FDA has come under criticism for the recent rejection of several newdrugs for rare diseases. Pharmaceutical firms and rare disease advocates have pointed at what they say are inconsistencies ...
Oct 21, 2025 · Amid the chaos of the Trump administration’s haphazard job cuts and a mass exodus of leadership, the Food and DrugAdministration is experiencing a slowdown of drug reviews and approvals,...