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199,371 Results for "fda".
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Cancer
FDA’s Multiple Myeloma Guidance Highlights Decade of Success
New draft guidance from the FDA on multiple myeloma endpoints reflects the new technology available to assess disease and how patient journeys have changed with better treatments.
January 30, 2026
·
4 min read
·
Dan Samorodnitsky
Manufacturing
FDA Launches PreCheck Program, Intended To Bring Manufacturers Home
The program will allow for frequent communication with the FDA, giving manufacturers timely input and guidance regarding the design of their facilities.
February 2, 2026
·
2 min read
·
Tristan Manalac
Rare diseases
Amgen Will Not Heed FDA Request To Withdraw Rare Disease Drug Tavneos
After review, Amgen is certain that Tavneos is effective and has a favorable benefit-risk profile. The company informed the FDA on January 28 that they would not pull the drug.
February 4, 2026
·
2 min read
·
Annalee Armstrong
Regulatory
FDA Action Alert: Sanofi/Regeneron, Merck, REGENXBIO and More
In what is shaping up to be a back-loaded month, the FDA is set to release a slew of regulatory decisions in February, including two that would expand the labels of blockbuster drugs.
February 2, 2026
·
7 min read
·
Tristan Manalac
Complete response letters
Vanda Slides After FDA Again Rejects Hetlioz For Jet Lag
The DC-based biopharma disputed the FDA’s conclusions regarding the data provided in its supplemental application for Hetlioz and promised to keep pushing for an approval.
January 8, 2026
·
2 min read
·
Dan Samorodnitsky
Regulatory
Summit’s Potential Keytruda Rival Gets November FDA Decision Date
The FDA is currently reviewing Summit’s PD-1/VEGF bispecific as part of a chemotherapy combo for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer.
January 30, 2026
·
1 min read
·
Tristan Manalac
Regulatory
FDA Carves Out Manufacturing Exemptions for CGTs To Accelerate Development
FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and gene therapies.
January 12, 2026
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2 min read
·
Tristan Manalac
FDA
FDA’s Commissioner’s Priority Voucher Program ‘Shrouded in Secrecy,’ Democratic Rep Says
Rep. Jake Auchincloss of Massachusetts said the Commissioner’s National Priority Voucher program did not receive congressional backing. The FDA has also not yet made disclosures for eight senior reviewers, according to Auchincloss.
February 4, 2026
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2 min read
·
Tristan Manalac
Approvals
Sentynl, Fortress Bounce Back With FDA Approval for Rare Pediatric Disease
The FDA previously rejected Zycubo for Menkes disease in October last year, citing issues with the drug’s manufacturing facility.
January 13, 2026
·
2 min read
·
Tristan Manalac
Gene editing
FDA Lifts One of Two Clinical Holds on Intellia’s ATTR Gene Editing Program
After a patient safety signal and then death, the FDA in October 2025 placed holds on two of the company’s CRISPR programs for hereditary transthyretin amyloidosis.
January 27, 2026
·
2 min read
·
Dan Samorodnitsky
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