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.

Compiled . Subscribe to this lane Methodology

Confidence

35 rows shown

Week of 16 February 2026

DateLaneCompanyEventConfidenceSource
FDANot named in the sourceFDA approved Bysanti (milsaperidone) on 20 February 2026.ConfirmedFDA novel drug approvals table: 2026:Bysanti

Week of 23 February 2026

DateLaneCompanyEventConfidenceSource
FDANot named in the sourceFDA approved Loargys (pegzilarginase-nbln) on 23 February 2026.ConfirmedFDA novel drug approvals table: 2026:Loargys
FDANot named in the sourceFDA approved Yuviwel (navepegritide) on 27 February 2026.ConfirmedFDA novel drug approvals table: 2026:Yuviwel

Week of 16 March 2026

DateLaneCompanyEventConfidenceSource
FDANot named in the sourceFDA approved Icotyde (icotrokinra) on 17 March 2026.ConfirmedFDA novel drug approvals table: 2026:Icotyde
FDANot named in the sourceFDA approved Lynavoy (linerixibat) on 17 March 2026 to treat cholestatic pruritus associated with primary biliary cholangitis.ConfirmedFDA novel drug approvals table: 2026:Lynavoy

Week of 23 March 2026

DateLaneCompanyEventConfidenceSource
FDANot named in the sourceFDA approved Avlayah (tividenofusp alfa-eknm) on 24 March 2026.ConfirmedFDA novel drug approvals table: 2026:Avlayah
FDANot named in the sourceFDA approved Lifyorli (relacorilant) on 25 March 2026.ConfirmedFDA novel drug approvals table: 2026:Lifyorli
FDANot named in the sourceFDA approved Awiqli (insulin icodec-abae) on 26 March 2026 to improve glycemic control in adults with type 2 diabetes mellitus.ConfirmedFDA novel drug approvals table: 2026:Awiqli

Week of 30 March 2026

DateLaneCompanyEventConfidenceSource
FDANot named in the sourceFDA approved Foundayo (orforglipron) on 1 April 2026.ConfirmedFDA novel drug approvals table: 2026:Foundayo

Week of 20 April 2026

DateLaneCompanyEventConfidenceSource
FDANot named in the sourceFDA approved Idvynso (doravirine and islatravir) on 20 April 2026.ConfirmedFDA novel drug approvals table: 2026:Idvynso

Week of 27 April 2026

DateLaneCompanyEventConfidenceSource
FDANot named in the sourceFDA approved Veppanu (vepdegestrant) on 1 May 2026.ConfirmedFDA novel drug approvals table: 2026:Veppanu

Week of 11 May 2026

DateLaneCompanyEventConfidenceSource
FDANot named in the sourceFDA approved Beqalzi (sonrotoclax) on 13 May 2026.ConfirmedFDA novel drug approvals table: 2026:Beqalzi
FDANot named in the sourceFDA approved Baxfendy (baxdrostat) on 15 May 2026 to treat hypertension in combination with other antihypertensive drugs.ConfirmedFDA novel drug approvals table: 2026:Baxfendy

Week of 18 May 2026

DateLaneCompanyEventConfidenceSource
FDANot named in the sourceFDA approved Hepcludex (bulevirtide-gmod) on 22 May 2026.ConfirmedFDA novel drug approvals table: 2026:Hepcludex

Week of 25 May 2026

DateLaneCompanyEventConfidenceSource
FDANot named in the sourceFDA approved Decnupaz (pivekimab sunirine-pvzy) on 27 May 2026 to treat adults with blastic plasmacytoid dendritic cell neoplasm.ConfirmedFDA novel drug approvals table: 2026:Decnupaz
FDANot named in the sourceFDA approved Cypsedo (cipepofol) on 29 May 2026 to induce general anesthesia in adults undergoing surgery.ConfirmedFDA novel drug approvals table: 2026:Cypsedo
FDANot named in the sourceFDA approved Xocova (ensitrelvir) on 29 May 2026.ConfirmedFDA novel drug approvals table: 2026:Xocova
FDANot named in the sourceFDA approved Zaynich (cefepime and zidebactam) on 29 May 2026.ConfirmedFDA novel drug approvals table: 2026:Zaynich

Week of 8 June 2026

DateLaneCompanyEventConfidenceSource
FDANot named in the sourceFDA approved Ambelvist (gadoquatrane) on 12 June 2026.ConfirmedFDA novel drug approvals table: 2026:Ambelvist

Week of 15 June 2026

DateLaneCompanyEventConfidenceSource
FDANot named in the sourceFDA granted accelerated approval to Tzield (teplizumab) on 15 June 2026.ConfirmedFDA press announcement: FDA news release
FDANot named in the sourceFDA approved Utebzi (tebipenem pivoxil) on 17 June 2026.ConfirmedFDA novel drug approvals table: 2026:Utebzi
FDANot named in the sourceFDA approved the first generic of Xofluza (baloxavir marboxil) on 17 June 2026.ConfirmedFDA press announcement: FDA news release

Week of 22 June 2026

DateLaneCompanyEventConfidenceSource
FDANot named in the sourceFDA approved Lumvoa (veligrotug-vvze) on 26 June 2026 to treat thyroid eye disease.ConfirmedFDA novel drug approvals table: 2026:Lumvoa

Week of 29 June 2026

DateLaneCompanyEventConfidenceSource
FDANot named in the sourceFDA approved a supplemental application for Casgevy (exagamglogene autotemcel) on 1 July 2026.ConfirmedFDA press announcement: FDA news release

Week of 6 July 2026

DateLaneCompanyEventConfidenceSource
FDANot named in the sourceFDA approved Trutakna (atacicept-vymj) on 7 July 2026.ConfirmedFDA novel drug approvals table: 2026:Trutakna

Week of 13 July 2026

DateLaneCompanyEventConfidenceSource
FDANot named in the sourceFDA approved Revtorpyk (gedatolisib) on 14 July 2026.ConfirmedFDA novel drug approvals table: 2026:Revtorpyk
FDANot named in the sourceFDA approved Lipfendra (enlicitide decanoate) on 15 July 2026 to reduce low-density lipoprotein cholesterol.ConfirmedFDA novel drug approvals table: 2026:Lipfendra
FDANot named in the sourceFDA approved Lipfendra (enlicitide) on 17 July 2026.ConfirmedFDA press announcement: FDA news release

Week of 20 July 2026

DateLaneCompanyEventConfidenceSource
FDANot named in the sourceFDA approved Jideytro (zidesamtinib) on 22 July 2026.ConfirmedFDA novel drug approvals table: 2026:Jideytro
FDANot named in the sourceFDA approved Lytenava (bevacizumab-vikg) on 24 July 2026 to treat patients with neovascular (wet) age-related macular degeneration.ConfirmedFDA novel drug approvals table: 2026:Lytenava
FDANot named in the sourceFDA approved Simtriyo (centanafadine) on 24 July 2026 to treat attention-deficit hyperactivity disorder.ConfirmedFDA novel drug approvals table: 2026:Simtriyo

Week of 27 July 2026

DateLaneCompanyEventConfidenceSource
FDACapricorAn FDA advisory committee meets on 29 July 2026 to review BLA 125842 from Capricor.ConfirmedFederal Register document: 2026-13096
FDAReplimuneAn FDA advisory committee meets on 30 July 2026 to review BLA 125827 from Replimune.ConfirmedFederal Register document: 2026-13810

Week of 3 August 2026

DateLaneCompanyEventConfidenceSource
FDANot named in the sourceFDA approved Orzeyful (oveporexton) on 5 August 2026 to treat narcolepsy type 1.ConfirmedFDA novel drug approvals table: 2026:Orzeyful
FDANot named in the sourceFDA granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg) on 6 August 2026.ConfirmedFDA 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

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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.