Posts

Fulcrum scraps SCD program, considers options after FDA takes hard line on safety risks

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Gilead Cancels Midstage HIV Trial as FDA Clinical Hold Remains Intact

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FDA Policy on RMAT Designations for Therapies on Clinical Hold Remains Unchanged

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FDA Lifts Clinical Hold on Intellia's MAGNITUDE-2 Phase 3 Trial for Nex-Z in ATTRv-PN

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FDA Lifts Hold on Rocket Pharmaceuticals' Pivotal Gene Therapy Study at Lower Dose

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FDA Delays Draw Contrasting Responses: Neurizon Cites Agency Strain, Omeros Takes Softer Tone

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Sarepta Therapeutics Faces FDA Crackdown after Third Patient Death; George Tidmarsh Named Top FDA Drug Regulator; Multiple Drugs Rejected; Pharma Invests Billions in US Manufacturing

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Sarepta Reports Third Patient Death in Gene Therapy Studies for Limb-Girdle Muscular Dystrophy

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FDA Places Clinical Hold on Five Gilead HIV Studies Due to Safety Concerns

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Patient Death in Rocket Pharmaceuticals Gene Therapy Trial Prompts FDA Clinical Hold

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FDA lifts clinical hold on Atara's Epstein-Barr T-cell programme

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FDA frees Amgen's phase 1 obesity asset from clinical trial hold

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Entrada tightens focus on Duchenne, axes 20% of staff

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FDA puts Vyne in a twist, slapping hold on psoriasis trial over testicular toxicity concerns

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FDA Pauses BioNTech's Malaria Vaccine Trial Amid Regulatory Scrutiny

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FDA puts BioNTechs malaria vaccine on clinical hold

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Atara Biotherapeutics Halves Workforce Amid FDA Setbacks for Key Therapies

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FDA Lifts Clinical Hold on Entrada's Duchenne Muscular Dystrophy Drug ENTR-601-44 After Two Years

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FDA Halts Amgen's Phase 1 Obesity Drug Trial: AMG 513 Study on Hold

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