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Human Drugs

BeiGene Drops Ociperlimab Development in Lung Cancer

BeiGene scraps the development of BGB-A1217 (ociperlimab), an anti-TIGIT antibody, as a potential treatment for lung cancer.

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Human Drugs

Accelerated Approval Faces Scrutiny After Cancer Drug Review

FDAs accelerated approval program faces renewed scrutiny after a recent JAMA study highlighted concerns about cancer drugs that remain available despi...

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Human Drugs

Biogen Gets Fast Track for Alzheimers Therapy

Biogen wins a fast-track designation for BIIB080, an investigational antisense oligonucleotide therapy for treating Alzheimers disease.

FDA General

Can FDA Do More With Less?: McClellan

Former FDA commissioner Mark McClellan says it will be a challenge for the agency to come through the massive reorganization and staff reduction that ...

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Animal Drugs

Industry Sounds the Alarm on FDA Staff Cuts

Industry associations sound alarms and frustrations as they weigh how FDA staff cuts will impact product development, FDA reviews and approvals.

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Human Drugs

Ocrevus IV Phase 3 Study Misses Primary Endpoint

Roche says the Phase 3 MUSETTE study found that a higher dose of Ocrevus IV did not provide more benefit than the approved 600 mg dose in treating rel...

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Human Drugs

Positive EDG-7500 Heart Drug Phase 2 Results

Edgewise Therapeutics says its EDG-7500 achieved positive results in the four-week CIRRUS-HCM trial in hypertrophic cardiomyopathy.

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FDA General

RFK Jr. Invited to Senate Hearing on HHS Reorganization

The Senate HELP Committee invites HHS secretary RFK, Jr., to testify on his reorganization of the department.

Biologics

FDA Misses Novavax Covid Vaccine Review Action

FDA misses its 4/1 user fee review action target date on a Novavax BLA seeking full approval for its current Covid-19 vaccine.

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FDA General

FDA Remaking Inspection Priorities in Wake of Trump Cuts

FDA says it is reprioritizing planned inspections for the rest of the year due to challenges it faces after 170 administrative and management staff we...