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GSK's Blood Cancer Drug Review Extended As FDA Seeks More Data

FDA extends Blenrep combo review to October to assess more data from Phase 3 trials in relapsed or refractory multiple myeloma.
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GSK says US FDA extends review period for Blenrep BLA until October

(Alliance News) - GSK PLC on Wednesday said the US Food & Drug Administration has extended the review period for Blenrep combinations in relapsed/refractory multiple myeloma after an advisory ...

Aldeyra says FDA accepted resubmitted marketing application for lead drug

Aldeyra Therapeutics (NASDAQ:ALDX) announced on Thursday that the U.S. Food and Drug Administration (FDA) accepted for review ...
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FDA Accepts Biologics License for Proposed Biosimilar to Simponi

The U.S. FDA has accepted a Biologics License Application (BLA) for BAT2506, a proposed biosimilar to Simponi (golimumab).
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FDA Layoffs, 200 Rejection Letters, User Fees and Priority Vouchers, Bad Week for Rare Disease

Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees ...
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PIRG to FDA: Engage the public in drug approvals.

The FDA’s mission is to protect public health. PIRG asked: "The prescription drug user fee reauthorization (PDUFA) process ...
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FDA Commissioner Marty Makary Proposes Lowering Industry User Fees

According to Makary, reducing user fees—which make up just under half of the FDA's budget—could make it easier for smaller ...
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U.S. FDA Accepts New Drug Application for Merck’s Doravirine ...

The FDA has set a target action date of April 28, 2026, for the application under the Prescription Drug User Fee Act (PDUFA).
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U.S. FDA Grants Orphan Drug Designation to Adcentrx Therapeutics ... - KTLA

Orphan drug designation highlights the potential for ADRX-0405 to address the high unmet need in gastric cancer SAN DIEGO, July 8, 2025 /PRNewswire/ -- Adcentrx Therapeutics ("Adcentrx"), a ...