FDA actions.
Regulatory actions the FDA has already taken, plus advisory committee meetings it has formally noticed in the Federal Register.
Read from FDA press announcements, the CDER Novel Drug Approvals table and the Federal Register API. Approvals are records of decisions already made. The FDA never publishes pending goal dates, so no forward PDUFA date appears here. Complete response letters are never published on this page at all.
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35 rows shown
Week of 16 February 2026
| Date | Lane | Company | Event | Confidence | Source |
|---|---|---|---|---|---|
| FDA | Not named in the source | FDA approved Bysanti (milsaperidone) on 20 February 2026. | Confirmed | FDA novel drug approvals table: 2026:Bysanti |
Week of 23 February 2026
| Date | Lane | Company | Event | Confidence | Source |
|---|---|---|---|---|---|
| FDA | Not named in the source | FDA approved Loargys (pegzilarginase-nbln) on 23 February 2026. | Confirmed | FDA novel drug approvals table: 2026:Loargys | |
| FDA | Not named in the source | FDA approved Yuviwel (navepegritide) on 27 February 2026. | Confirmed | FDA novel drug approvals table: 2026:Yuviwel |
Week of 16 March 2026
| Date | Lane | Company | Event | Confidence | Source |
|---|---|---|---|---|---|
| FDA | Not named in the source | FDA approved Icotyde (icotrokinra) on 17 March 2026. | Confirmed | FDA novel drug approvals table: 2026:Icotyde | |
| FDA | Not named in the source | FDA approved Lynavoy (linerixibat) on 17 March 2026 to treat cholestatic pruritus associated with primary biliary cholangitis. | Confirmed | FDA novel drug approvals table: 2026:Lynavoy |
Week of 23 March 2026
| Date | Lane | Company | Event | Confidence | Source |
|---|---|---|---|---|---|
| FDA | Not named in the source | FDA approved Avlayah (tividenofusp alfa-eknm) on 24 March 2026. | Confirmed | FDA novel drug approvals table: 2026:Avlayah | |
| FDA | Not named in the source | FDA approved Lifyorli (relacorilant) on 25 March 2026. | Confirmed | FDA novel drug approvals table: 2026:Lifyorli | |
| FDA | Not named in the source | FDA approved Awiqli (insulin icodec-abae) on 26 March 2026 to improve glycemic control in adults with type 2 diabetes mellitus. | Confirmed | FDA novel drug approvals table: 2026:Awiqli |
Week of 30 March 2026
| Date | Lane | Company | Event | Confidence | Source |
|---|---|---|---|---|---|
| FDA | Not named in the source | FDA approved Foundayo (orforglipron) on 1 April 2026. | Confirmed | FDA novel drug approvals table: 2026:Foundayo |
Week of 20 April 2026
| Date | Lane | Company | Event | Confidence | Source |
|---|---|---|---|---|---|
| FDA | Not named in the source | FDA approved Idvynso (doravirine and islatravir) on 20 April 2026. | Confirmed | FDA novel drug approvals table: 2026:Idvynso |
Week of 27 April 2026
| Date | Lane | Company | Event | Confidence | Source |
|---|---|---|---|---|---|
| FDA | Not named in the source | FDA approved Veppanu (vepdegestrant) on 1 May 2026. | Confirmed | FDA novel drug approvals table: 2026:Veppanu |
Week of 11 May 2026
| Date | Lane | Company | Event | Confidence | Source |
|---|---|---|---|---|---|
| FDA | Not named in the source | FDA approved Beqalzi (sonrotoclax) on 13 May 2026. | Confirmed | FDA novel drug approvals table: 2026:Beqalzi | |
| FDA | Not named in the source | FDA approved Baxfendy (baxdrostat) on 15 May 2026 to treat hypertension in combination with other antihypertensive drugs. | Confirmed | FDA novel drug approvals table: 2026:Baxfendy |
Week of 18 May 2026
| Date | Lane | Company | Event | Confidence | Source |
|---|---|---|---|---|---|
| FDA | Not named in the source | FDA approved Hepcludex (bulevirtide-gmod) on 22 May 2026. | Confirmed | FDA novel drug approvals table: 2026:Hepcludex |
Week of 25 May 2026
| Date | Lane | Company | Event | Confidence | Source |
|---|---|---|---|---|---|
| FDA | Not named in the source | FDA approved Decnupaz (pivekimab sunirine-pvzy) on 27 May 2026 to treat adults with blastic plasmacytoid dendritic cell neoplasm. | Confirmed | FDA novel drug approvals table: 2026:Decnupaz | |
| FDA | Not named in the source | FDA approved Cypsedo (cipepofol) on 29 May 2026 to induce general anesthesia in adults undergoing surgery. | Confirmed | FDA novel drug approvals table: 2026:Cypsedo | |
| FDA | Not named in the source | FDA approved Xocova (ensitrelvir) on 29 May 2026. | Confirmed | FDA novel drug approvals table: 2026:Xocova | |
| FDA | Not named in the source | FDA approved Zaynich (cefepime and zidebactam) on 29 May 2026. | Confirmed | FDA novel drug approvals table: 2026:Zaynich |
Week of 8 June 2026
| Date | Lane | Company | Event | Confidence | Source |
|---|---|---|---|---|---|
| FDA | Not named in the source | FDA approved Ambelvist (gadoquatrane) on 12 June 2026. | Confirmed | FDA novel drug approvals table: 2026:Ambelvist |
Week of 15 June 2026
| Date | Lane | Company | Event | Confidence | Source |
|---|---|---|---|---|---|
| FDA | Not named in the source | FDA granted accelerated approval to Tzield (teplizumab) on 15 June 2026. | Confirmed | FDA press announcement: FDA news release | |
| FDA | Not named in the source | FDA approved Utebzi (tebipenem pivoxil) on 17 June 2026. | Confirmed | FDA novel drug approvals table: 2026:Utebzi | |
| FDA | Not named in the source | FDA approved the first generic of Xofluza (baloxavir marboxil) on 17 June 2026. | Confirmed | FDA press announcement: FDA news release |
Week of 22 June 2026
| Date | Lane | Company | Event | Confidence | Source |
|---|---|---|---|---|---|
| FDA | Not named in the source | FDA approved Lumvoa (veligrotug-vvze) on 26 June 2026 to treat thyroid eye disease. | Confirmed | FDA novel drug approvals table: 2026:Lumvoa |
Week of 29 June 2026
| Date | Lane | Company | Event | Confidence | Source |
|---|---|---|---|---|---|
| FDA | Not named in the source | FDA approved a supplemental application for Casgevy (exagamglogene autotemcel) on 1 July 2026. | Confirmed | FDA press announcement: FDA news release |
Week of 6 July 2026
| Date | Lane | Company | Event | Confidence | Source |
|---|---|---|---|---|---|
| FDA | Not named in the source | FDA approved Trutakna (atacicept-vymj) on 7 July 2026. | Confirmed | FDA novel drug approvals table: 2026:Trutakna |
Week of 13 July 2026
| Date | Lane | Company | Event | Confidence | Source |
|---|---|---|---|---|---|
| FDA | Not named in the source | FDA approved Revtorpyk (gedatolisib) on 14 July 2026. | Confirmed | FDA novel drug approvals table: 2026:Revtorpyk | |
| FDA | Not named in the source | FDA approved Lipfendra (enlicitide decanoate) on 15 July 2026 to reduce low-density lipoprotein cholesterol. | Confirmed | FDA novel drug approvals table: 2026:Lipfendra | |
| FDA | Not named in the source | FDA approved Lipfendra (enlicitide) on 17 July 2026. | Confirmed | FDA press announcement: FDA news release |
Week of 20 July 2026
| Date | Lane | Company | Event | Confidence | Source |
|---|---|---|---|---|---|
| FDA | Not named in the source | FDA approved Jideytro (zidesamtinib) on 22 July 2026. | Confirmed | FDA novel drug approvals table: 2026:Jideytro | |
| FDA | Not named in the source | FDA approved Lytenava (bevacizumab-vikg) on 24 July 2026 to treat patients with neovascular (wet) age-related macular degeneration. | Confirmed | FDA novel drug approvals table: 2026:Lytenava | |
| FDA | Not named in the source | FDA approved Simtriyo (centanafadine) on 24 July 2026 to treat attention-deficit hyperactivity disorder. | Confirmed | FDA novel drug approvals table: 2026:Simtriyo |
Week of 27 July 2026
| Date | Lane | Company | Event | Confidence | Source |
|---|---|---|---|---|---|
| FDA | Capricor | An FDA advisory committee meets on 29 July 2026 to review BLA 125842 from Capricor. | Confirmed | Federal Register document: 2026-13096 | |
| FDA | Replimune | An FDA advisory committee meets on 30 July 2026 to review BLA 125827 from Replimune. | Confirmed | Federal Register document: 2026-13810 |
Week of 3 August 2026
| Date | Lane | Company | Event | Confidence | Source |
|---|---|---|---|---|---|
| FDA | Not named in the source | FDA approved Orzeyful (oveporexton) on 5 August 2026 to treat narcolepsy type 1. | Confirmed | FDA novel drug approvals table: 2026:Orzeyful | |
| FDA | Not named in the source | FDA granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg) on 6 August 2026. | Confirmed | FDA press announcement: FDA news release |
What this does not cover
The calendar reads government registers and nothing else. It has no view of anything a company has not filed, and no free source publishes pending FDA goal dates, so approval decision dates are absent by construction rather than by omission. An empty week is not evidence that nothing is scheduled that week. Read a gap as a gap in the registers.
Complete response letters are never published here. Neither are live offerings. Both exclusions are deliberate and permanent. The methodology page sets out every source, every gate and the current drop rate.
How it is compiled
Rows are written automatically from primary documents once a day. Nobody reviews each row before it appears. Every sentence is composed from structured fields taken out of the filing, never from the wording of the source, and each one carries the date on which the claim was made so it stays true after a date slips.
Not investment advice
Nothing here is a recommendation to buy or sell anything, and none of it is tailored to any reader. This page is identical for every visitor. It reports what public registers say, and public registers are wrong often enough that you should check the linked document before you act on a row.
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Citing this page
Willard, J. Biotech catalyst calendar. julienwillard.com/calendar, as of 12 August 2026, 01:32 UTC. Licensed CC BY 4.0.