Among reasons for the rejection, the agency cited a lack of US patient representation in the STARGLO trial assessing ...

On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its ...

Qure advances its pathology-shifting AMT-130 therapy for Huntington's disease; pivotal data and commercial launch prep target 2025 milestones.

In the ever shifting theatre of global militancy, women are no longer just sitting in the wings, but have, unfortunately, ...

Sette added that like rodents, cockroaches produce important allergens, particularly in under-resourced urban settings.

Vinay Prasad exits FDA's biologics division following pressure over Sarepta's Elevidys approval and regulatory controversies.

As insurgents escalate their offensive against Pakistani forces in Balochistan, Munir’s rhetoric looks increasingly like a ...

The FDA has accepted for priority review the resubmitted BLA for tabelecleucel to treat patients 2 years of age and older with EBV+ PTLD who have received at least 1 prior therapy.

GSK tops Q2 estimates with growth in vaccines and specialty drugs, raises 2025 forecast amid progress in major late-stage ...

ISKP is weaker than the BLA in Balochistan. That could restrain it from attacking the latter in the immediate future.

The FDA’s top vaccine and gene therapy official resigned amid heightened scrutiny over recent drug approval decisions and ...

Under the Inflation Reduction Act, medications with the same active ingredient will be treated as the same drug for price ...