January 8, 2026 – Talk Bio

Sanofi calls FDA rejection of potential MS blockbuster tolebrutinib “unexpected” amid evolving agency views on benefit–risk

1 day ago talkbio0Tagged BTK inhibitor, Complete Response Letter, DILI, Mississippi (geographic location), Multiple Sclerosis, nrSPMS, PERSEUS trial, perspectives, Progressive, Rejection, sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; multiple sclerosis; nrSPMS; BTK inhibitor; FDA rejection; complete response letter; DILI; primary progressive MS; Perseus trial; evolving FDA perspectives

2025 FDA staff cuts and their impact on new drug review timelines

1 day ago talkbio0Tagged 2025, CHARGE Syndrome, Drug Approval, drug review, HHS, layoffs, PDUFA, Programs - Publication Format, regulatory timelines, RFK gene, Staff, TimeLine Fluoride Releasing Resin, United States Food and Drug Administration, user fee, Workforce

FDA layoffs 2025; drug review timelines; user fee programs; HHS staff cuts; RFK Jr. layoffs; PDUFA; regulatory timelines; drug approvals; FDA workforce reductions

Sanofi calls FDA rejection of potential MS blockbuster tolebrutinib “unexpected” amid evolving agency views on benefit–risk

1 day ago talkbio0Tagged BTK inhibitor, Complete Response Letter, DILI, Mississippi (geographic location), Multiple Sclerosis, nrSPMS, PERSEUS trial, perspectives, Progressive, Rejection, sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; multiple sclerosis; nrSPMS; BTK inhibitor; FDA rejection; complete response letter; DILI; primary progressive MS; Perseus trial; evolving FDA perspectives

2025 FDA staff cuts and their impact on new drug review timelines

1 day ago talkbio0Tagged 2025, CHARGE Syndrome, Drug Approval, drug review, HHS, layoffs, PDUFA, Programs - Publication Format, regulatory timelines, RFK gene, Staff, TimeLine Fluoride Releasing Resin, United States Food and Drug Administration, user fee, Workforce

FDA layoffs 2025; drug review timelines; user fee programs; HHS staff cuts; RFK Jr. layoffs; PDUFA; regulatory timelines; drug approvals; FDA workforce reductions

Sanofi calls FDA rejection of potential MS blockbuster tolebrutinib “unexpected” amid evolving agency views on benefit–risk

1 day ago talkbio0Tagged BTK inhibitor, Complete Response Letter, DILI, Mississippi (geographic location), Multiple Sclerosis, nrSPMS, PERSEUS trial, perspectives, Progressive, Rejection, sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; multiple sclerosis; nrSPMS; BTK inhibitor; FDA rejection; complete response letter; DILI; primary progressive MS; Perseus trial; evolving FDA perspectives

2025 FDA staff cuts and their impact on new drug review timelines

1 day ago talkbio0Tagged 2025, CHARGE Syndrome, Drug Approval, drug review, HHS, layoffs, PDUFA, Programs - Publication Format, regulatory timelines, RFK gene, Staff, TimeLine Fluoride Releasing Resin, United States Food and Drug Administration, user fee, Workforce

FDA layoffs 2025; drug review timelines; user fee programs; HHS staff cuts; RFK Jr. layoffs; PDUFA; regulatory timelines; drug approvals; FDA workforce reductions

Parabilis raises $305M to advance Helicon peptide cancer drugs against ‘undruggable’ targets

1 day ago talkbio0Tagged cancer drug development, Capital, Fibromatosis, Aggressive, fidelity, FOG-001, FogPharma, Helicon peptide platform, Janus Henderson, Malignant neoplasm of prostate, Parabilis Medicines, Rheumatoid Arthritis, Series F financing, targets, venture capital, zolucatetide

Parabilis Medicines; FogPharma; $305 million; Series F financing; undruggable targets; Helicon peptide platform; zolucatetide; FOG-001; desmoid tumors; prostate cancer; cancer drug development; venture capital; RA Capital; Fidelity; Janus Henderson

Parabilis raises $305M to advance Helicon peptide cancer drugs against ‘undruggable’ targets

1 day ago talkbio0Tagged cancer drug development, Capital, Fibromatosis, Aggressive, fidelity, FOG-001, FogPharma, Helicon peptide platform, Janus Henderson, Malignant neoplasm of prostate, Parabilis Medicines, Rheumatoid Arthritis, Series F financing, targets, venture capital, zolucatetide

Parabilis Medicines; FogPharma; $305 million; Series F financing; undruggable targets; Helicon peptide platform; zolucatetide; FOG-001; desmoid tumors; prostate cancer; cancer drug development; venture capital; RA Capital; Fidelity; Janus Henderson

Parabilis raises $305M to advance Helicon peptide cancer drugs against ‘undruggable’ targets

1 day ago talkbio0Tagged cancer drug development, Capital, Fibromatosis, Aggressive, fidelity, FOG-001, FogPharma, Helicon peptide platform, Janus Henderson, Malignant neoplasm of prostate, Parabilis Medicines, Rheumatoid Arthritis, Series F financing, targets, venture capital, zolucatetide

Parabilis Medicines; FogPharma; $305 million; Series F financing; undruggable targets; Helicon peptide platform; zolucatetide; FOG-001; desmoid tumors; prostate cancer; cancer drug development; venture capital; RA Capital; Fidelity; Janus Henderson

VC Funding Uptick in Back Half of 2025 Has Analysts Hopeful for 2026

1 day ago talkbio0Tagged 2026, AI-driven, Attitude, Funding, Investments, IPO, M&A activity, MassBio, rates, venture capital, Vital capacity, Window (physical object)

venture capital; VC funding; 2025 H2; 2026 outlook; biotech; MassBio; IPO window; M&A activity; interest rates; AI-driven investment