FDA extends Sarclisa subcutaneous US action date by three months to July 23, 2026
The FDA’s decision on Sanofi’s Sarclisa (isatuximab-irfc) subcutaneous for Multiple myeloma was due on Apr 22, 2026. The outcome isn’t recorded here yet — the linked source has the latest.
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- Company
- Sanofi SNY
- Drug
- Sarclisa (isatuximab-irfc) subcutaneous
- For
- Multiple myeloma
- Stage
- Registrational · a study designed to support approval
- When
- Apr 22, 2026
- Source note
- Sanofi said the FDA extended by up to three months the target action date for the subcutaneous Sarclisa BLA across all approved multiple myeloma indications, pushing the decision to July 23, 2026.
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- Source: sanofi.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- SNY headlines on this site
Sanofi expects to report results from its Phase 3 study of Sarclisa (isatuximab) for Transplant-eligible newly diagnosed multiple myeloma in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
More details
- Entry
- Sarclisa Phase 3 data in transplant-eligible multiple myeloma · Clinical trial results (readout / topline data)
- Drug
- Sarclisa (isatuximab)
- For
- Transplant-eligible newly diagnosed multiple myeloma
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Listed in the 'anticipated major upcoming pipeline milestones — H2 2026' table of Sanofi's Q2 2026 results press release (July 30, 2026).
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- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- SNY headlines on this site
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Efdoralprin alfa US regulatory submission in alpha-1 antitrypsin deficiency, expected in the second half of 2026 (no exact date yet). A company milestone for Sanofi (Efdoralprin alfa for Alpha-1 antitrypsin deficiency emphysema): a step in the program rather than a decision or a data readout.
More details
- Entry
- Efdoralprin alfa US regulatory submission in alpha-1 antitrypsin deficiency · Company milestone
- Drug
- Efdoralprin alfa
- For
- Alpha-1 antitrypsin deficiency emphysema
- Stage
- Registrational · a study designed to support approval
- When
- H2 2026 · the company gave a window, not a day
- Source note
- US regulatory submission listed under H2 2026 milestones in Sanofi's Q2 2026 results press release.
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- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
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The FDA is expected to decide in the second half of 2026 (no exact date yet) whether to approve Sanofi’s Fluzone HD / Efluelda for Influenza, adults aged 50+. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
More details
- Entry
- FDA decision on Fluzone High-Dose/Efluelda for adults 50+ · FDA decision due (PDUFA date)
- Drug
- Fluzone HD / Efluelda
- For
- Influenza, adults aged 50+
- Stage
- sBLA under review
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Sanofi Q2 2026 press release 'Anticipated major upcoming pipeline milestones' table (Jul 30, 2026); EU decision guided for 2027.
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- Source: sanofi.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- SNY headlines on this site
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Sanofi expects Japanese regulators to decide on Dupixent (dupilumab) for Chronic spontaneous urticaria (children); allergic fungal rhinosinusitis in the second half of 2026 (no exact date yet). An approval lets the company start selling it in that market.
More details
- Entry
- Japan decision on Dupixent in pediatric chronic spontaneous urticaria · Regulatory approval
- Drug
- Dupixent (dupilumab)
- For
- Chronic spontaneous urticaria (children); allergic fungal rhinosinusitis
- Stage
- Under MHLW review
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Sanofi Q2 2026 milestones table.
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- Source: sanofi.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- SNY headlines on this site
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Nexviazyme US label-extension submission for infantile-onset Pompe disease, expected in the second half of 2026 (no exact date yet). A company milestone for Sanofi (Nexviazyme (avalglucosidase alfa) for Infantile-onset Pompe disease): a step in the program rather than a decision or a data readout.
More details
- Entry
- Nexviazyme US label-extension submission for infantile-onset Pompe disease · Company milestone
- Drug
- Nexviazyme (avalglucosidase alfa)
- For
- Infantile-onset Pompe disease
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Sanofi Q2 2026 press release; Baby-COMET met primary and all secondary endpoints.
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SP0087 rabies vaccine EU decision and US submission, expected in the second half of 2026 (no exact date yet). A company milestone for Sanofi (SP0087 for Rabies): a step in the program rather than a decision or a data readout.
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- Entry
- SP0087 rabies vaccine EU decision and US submission · Company milestone
- Drug
- SP0087
- For
- Rabies
- Stage
- Regulatory
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Sanofi Q2 2026 milestones table (row layout slightly ambiguous in PDF extraction).
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- Source: sanofi.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- SNY headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page