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calendar

18,993 catalysts · 18,987 approval · 7,115 phase readout · 5,000 device 510k · 4,728 grant · 3,583 8k filing · 2,000 device pma

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soonest latest type sponsor alpha

type: filing×type: approval×clear all

type

approval18,987
phase readout7,115
device 510k5,000
grant4,728
8k filing3,583
device pma2,000
device recall

2,000

recall1,126

device adverse event1,000

earnings585

therapy area

Ophthalmology5

Week of Dec 16, 2024

›Dec 20, 2024approval617d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

Sponsor: PHARMACYCLICS LLC. Form: SUSPENSION. Route: ORAL

full page →fda approvals ↗

›Dec 20, 2024approval617d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

Sponsor: PHARMACYCLICS LLC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Week of Dec 23, 2024

›Dec 23, 2024approval614d agoYUFLYMA (ADALIMUMAB-AATY) — FDA approvalYUFLYMA

Sponsor: CELLTRION. Form: INJECTABLE. Route: INJECTION

full page →YUFLYMA →fda approvals ↗

›Dec 26, 2024approval

Week of Dec 30, 2024

›Dec 30, 2024approval607d agoREZUROCK (BELUMOSUDIL MESYLATE) — FDA approvalbelumosudil mesylate

Sponsor: KADMON PHARMS LLC. Form: TABLET. Route: ORAL

full page →belumosudil mesylate →fda approvals ↗

›Dec 31, 2024approval

Week of Jan 6, 2025

›Jan 7, 2025approval599d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: ACTAVIS ELIZABETH. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗

›Jan 7, 2025approval

Week of Jan 13, 2025

›Jan 13, 2025approval593d agoLURASIDONE HYDROCHLORIDE — FDA approvalLURASIDONE HYDROCHLORIDE

Sponsor: TORRENT. Form: TABLET. Route: ORAL

full page →LURASIDONE HYDROCHLORIDE →fda approvals ↗

›Jan 15, 2025approval

Week of Jan 20, 2025

›Jan 21, 2025approval585d agoPOTELIGEO (MOGAMULIZUMAB-KPKC) — FDA approvalmogamulizumab

Sponsor: KYOWA KIRIN. Form: INJECTABLE. Route: INJECTION

full page →mogamulizumab →fda approvals ↗

›Jan 21, 2025approval

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page 318 of 380

611d ago

EBANGA (ANSUVIMAB-ZYKL) — FDA approvalansuvimab

Sponsor: RIDGEBACK BIOTHERAPEUTICS. Form: POWDER. Route: IV (INFUSION)

full page →ansuvimab →fda approvals ↗

›Dec 26, 2024approval611d agoWEZLANA (USTEKINUMAB-AUUB) — FDA approvalWEZLANA

Sponsor: AMGEN INC. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

full page →WEZLANA →fda approvals ↗

›Dec 26, 2024approval611d agoWEZLANA (USTEKINUMAB-AUUB) — FDA approvalWEZLANA

Sponsor: AMGEN INC. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

full page →WEZLANA →fda approvals ↗

›Dec 27, 2024approval610d agoOPDIVO QVANTIG (NIVOLUMAB) — FDA approval(hyaluronidase (recombinant, human) + nivolumab)

Sponsor: BRISTOL-MYERS SQUIBB. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →(hyaluronidase (recombinant, human) + nivolumab) →fda approvals ↗

606d ago

SPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL

full page →fda approvals ↗

›Dec 31, 2024approval606d agoGABAPENTIN — FDA approvalSciegen Pharmaceuticals Inc

Sponsor: SCIEGEN PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Dec 31, 2024approval606d agoGABAPENTIN — FDA approvalSciegen Pharmaceuticals Inc

Sponsor: SCIEGEN PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Dec 31, 2024approval606d agoGABAPENTIN — FDA approvalSciegen Pharmaceuticals Inc

Sponsor: SCIEGEN PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Dec 31, 2024approval606d agoRELGAABI (GABAPENTIN) — FDA approvalSciegen Pharmaceuticals Inc

Sponsor: SCIEGEN PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Dec 31, 2024approval606d agoRELGAABI (GABAPENTIN) — FDA approvalSciegen Pharmaceuticals Inc

Sponsor: SCIEGEN PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Dec 31, 2024approval606d agoRELGAABI (GABAPENTIN) — FDA approvalSciegen Pharmaceuticals Inc

Sponsor: SCIEGEN PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Dec 31, 2024approval606d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: LAURUS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Dec 31, 2024approval606d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: LAURUS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Jan 3, 2025approval603d agoPYRUKYND (MITAPIVAT SULFATE) — FDA approvalAGIOS PHARMACEUTICALS, INC.

Sponsor: AGIOS PHARMS INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

599d ago

GABAPENTIN — FDA approvalGABAPENTIN

Sponsor: ACTAVIS ELIZABETH. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗

›Jan 7, 2025approval599d agoDEMEROL (MEPERIDINE HYDROCHLORIDE) — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

›Jan 8, 2025approval598d agoLAMOTRIGINE — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Jan 10, 2025approval596d agoFLONASE SENSIMIST ALLERGY RELIEF (FLUTICASONE FUROATE) — FDA approvalGlaxoSmithKline LLC

Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL

full page →fda approvals ↗

›Jan 10, 2025approval596d agoFLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) — FDA approvalParatek Pharmaceuticals Inc

Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL

full page →fda approvals ↗

›Jan 10, 2025approval596d agoVEKLURY (REMDESIVIR) — FDA approvalremdesivir

Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: INTRAVENOUS

full page →remdesivir →fda approvals ↗

591d ago

OMVOH (MIRIKIZUMAB-MRKZ) — FDA approvalmirikizumab

Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →mirikizumab →fda approvals ↗

›Jan 15, 2025approval591d agoOMVOH (MIRIKIZUMAB-MRKZ) — FDA approvalmirikizumab

Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →mirikizumab →fda approvals ↗

›Jan 16, 2025approval590d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

›Jan 16, 2025approval590d agoARTESUNATE — FDA approvalARTESUNATE

Sponsor: AMIVAS. Form: POWDER. Route: INTRAVENOUS

full page →ARTESUNATE →fda approvals ↗

›Jan 16, 2025approval590d agoCALQUENCE (ACALABRUTINIB MALEATE) — FDA approvalCALQUENCE

Sponsor: ASTRAZENECA. Form: TABLET. Route: ORAL

full page →CALQUENCE →fda approvals ↗

›Jan 16, 2025approval590d agoCALQUENCE (ACALABRUTINIB) — FDA approvalCALQUENCE

Sponsor: ASTRAZENECA. Form: CAPSULE. Route: ORAL

full page →CALQUENCE →fda approvals ↗

›Jan 17, 2025approval589d agoSPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL

full page →fda approvals ↗

›Jan 17, 2025approval589d agoELELYSO (TALIGLUCERASE ALFA) — FDA approvaltaliglucerase alfa

Sponsor: PFIZER. Form: POWDER. Route: INTRAVENOUS

full page →taliglucerase alfa →fda approvals ↗

›Jan 17, 2025approval589d agoPEPCID COMPLETE (CALCIUM CARBONATE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL

full page →fda approvals ↗

585d ago

EPYSQLI (ECULIZUMAB-AAGH) — FDA approvalEPYSQLI

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION

full page →EPYSQLI →fda approvals ↗

›Jan 21, 2025approval585d agoADDYI (FLIBANSERIN) — FDA approvalSprout2 Inc

Sponsor: SPROUT PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jan 22, 2025approval584d agoHALOPERIDOL — FDA approvalHALOPERIDOL

Sponsor: AIPING PHARM INC. Form: TABLET. Route: ORAL

full page →HALOPERIDOL →fda approvals ↗

›Jan 22, 2025approval584d agoFINGOLIMOD HYDROCHLORIDE — FDA approvalFINGOLIMOD HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA LTD. Form: CAPSULE. Route: ORAL

full page →FINGOLIMOD HYDROCHLORIDE →fda approvals ↗

›Jan 22, 2025approval584d agoZYPREXA ZYDIS (OLANZAPINE) — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: CHEPLAPHARM. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →fda approvals ↗

›Jan 22, 2025approval584d agoZYPREXA RELPREVV (OLANZAPINE PAMOATE) — FDA approvalCHEPLAPHARM Arzneimittel GmbH

Sponsor: CHEPLAPHARM. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →fda approvals ↗

›Jan 22, 2025approval584d agoZYPREXA (OLANZAPINE) — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jan 22, 2025approval584d agoZYPREXA (OLANZAPINE) — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

Sponsor: CHEPLAPHARM. Form: POWDER. Route: INTRAMUSCULAR

full page →fda approvals ↗

›Jan 22, 2025approval584d agoLYBALVI (OLANZAPINE) — FDA approval(olanzapine + samidorphan l-malate)

Sponsor: ALKERMES INC. Form: TABLET. Route: ORAL

full page →(olanzapine + samidorphan l-malate) →fda approvals ↗

›Jan 22, 2025approval584d agoABILIFY MAINTENA KIT (ARIPIPRAZOLE) — FDA approvalaripiprazole LA

Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →aripiprazole LA →fda approvals ↗

›Jan 22, 2025approval584d agoRYKINDO (RISPERIDONE) — FDA approvalDelpor Inc

Sponsor: SHANDONG LUYE. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →fda approvals ↗

›Jan 22, 2025approval584d agoFINGOLIMOD HYDROCHLORIDE — FDA approvalFINGOLIMOD HYDROCHLORIDE

Sponsor: GLENMARK PHARMS LTD. Form: CAPSULE. Route: ORAL

full page →FINGOLIMOD HYDROCHLORIDE →fda approvals ↗

›Jan 22, 2025approval584d agoFINGOLIMOD HYDROCHLORIDE — FDA approvalFINGOLIMOD HYDROCHLORIDE

Sponsor: GLENMARK PHARMS LTD. Form: CAPSULE. Route: ORAL

full page →FINGOLIMOD HYDROCHLORIDE →fda approvals ↗

›Jan 22, 2025approval584d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

Sponsor: ASTELLAS. Form: TABLET. Route: ORAL

full page →enzalutamide →fda approvals ↗

$ABBV259.04-1.47%

$AZN164.52-1.05%

$LLY1189.41-3.59%

$AMGN439.48-0.20%

$LLY1189.41-3.59%

$BMY67.25-0.48%

$AMGN439.48-0.20%

$AGIO34.28+0.85%

$GILD147.94-0.10%

$KVUE19.20-0.10%

$RDY12.19-0.29%

$TEVA37.84-0.22%

$PFE28.03-0.96%

$ALKS48.90-0.53%