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calendar

23,460 catalysts · 5,000 device 510k · 4,728 grant · 3,893 approval · 3,048 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

from 2024-04-30×clear all

type

device 510k5,000
grant4,728
approval3,893
8k filing3,048
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

earnings582

phase 2 completion172

therapy area

Oncology148
Infectious Disease46
Cardiology37
Immunology35
Dermatology31
Pulmonology22
Women's Health19
Ophthalmology16
Pain15

Week of May 6, 2024

›May 9, 2024approval824d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

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

full page →fda approvals ↗

›May 9, 2024approval824d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

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

full page →fda approvals ↗

›May 10, 2024approval823d agoFLUTICASONE PROPIONATE — FDA approvalFluticasone Propionate Glenmark

Sponsor: AUROBINDO PHARMA LTD. Form: SPRAY, METERED. Route: NASAL

full page →Fluticasone Propionate Glenmark →fda approvals ↗

Week of May 13, 2024

›May 13, 2024approval820d agoMEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›May 14, 2024approval

Week of May 20, 2024

›May 20, 2024approval813d agoOPUVIZ (AFLIBERCEPT-YSZY) — FDA approvalOPUVIZ

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

full page →OPUVIZ →fda approvals ↗

›May 20, 2024approval

Week of May 27, 2024

›May 28, 2024approval805d agoBKEMV (ECULIZUMAB-AEEB) — FDA approvaleculizumab biosimilar

Sponsor: AMGEN INC. Form: INJECTABLE. Route: INJECTION

full page →eculizumab biosimilar →fda approvals ↗

›May 28, 2024approval

Week of Jun 3, 2024

›Jun 3, 2024approval799d agoDIVALPROEX SODIUM — FDA approvalUnichem Pharmaceuticals (USA) Inc

Sponsor: UNICHEM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Jun 4, 2024approval

Week of Jun 10, 2024

›Jun 10, 2024approval792d agoAUBAGIO (TERIFLUNOMIDE) — FDA approvalteriflunomide

Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

full page →teriflunomide →fda approvals ↗

›Jun 11, 2024approval

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page 2 of 470

819d ago

XELJANZ XR (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

Sponsor: PFIZER. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tofacitinib citrate ER →fda approvals ↗

›May 14, 2024approval819d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›May 14, 2024approval819d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

Sponsor: PFIZER. Form: SOLUTION. Route: ORAL

full page →tofacitinib citrate ER →fda approvals ↗

›May 15, 2024approval818d agoACETAZOLAMIDE — FDA approvalACETAZOLAMIDE

Sponsor: MANKIND PHARMA. Form: TABLET. Route: ORAL

full page →ACETAZOLAMIDE →fda approvals ↗

›May 16, 2024approval817d agoREBLOZYL (LUSPATERCEPT-AAMT) — FDA approvalluspatercept

Sponsor: CELGENE CORP. Form: POWDER. Route: SUBCUTANEOUS

full page →luspatercept →fda approvals ↗

›May 16, 2024approval817d agoIMDELLTRA (TARLATAMAB-DLLE) — FDA approvaltarlatamab

Sponsor: AMGEN INC. Form: INJECTABLE. Route: INJECTION

full page →tarlatamab →fda approvals ↗

›May 17, 2024approval816d agoEPRONTIA (TOPIRAMATE) — FDA approvaltopiramate ER

Sponsor: AZURITY. Form: SOLUTION. Route: ORAL

full page →topiramate ER →fda approvals ↗

813d ago

YESAFILI (AFLIBERCEPT-JBVF) — FDA approvalYESAFILI

Sponsor: BIOCON BIOLOGICS INC. Form: INJECTABLE. Route: INJECTION

full page →YESAFILI →fda approvals ↗

›May 20, 2024approval813d agoVORICONAZOLE — FDA approvalGreenstone LLC

Sponsor: NOVEL LABS INC. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

›May 23, 2024approval810d agoLICART (DICLOFENAC EPOLAMINE) — FDA approvalAmzell Limited

Sponsor: IBSA INST BIO. Form: SYSTEM. Route: TOPICAL

full page →fda approvals ↗

›May 24, 2024approval809d agoFLAREX (FLUOROMETHOLONE ACETATE) — FDA approvalHARROW, INC.

Sponsor: HARROW EYE. Form: SUSPENSION/DROPS. Route: OPHTHALMIC

full page →fda approvals ↗

805d ago

TECVAYLI (TECLISTAMAB-CQYV) — FDA approvalteclistamab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →teclistamab →fda approvals ↗

›May 28, 2024approval805d agoTRAMADOL HYDROCHLORIDE — FDA approvalGraviti Pharmaceuticals Inc

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

full page →fda approvals ↗

›May 29, 2024approval804d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: IPCA LABS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›May 29, 2024approval804d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL

full page →selpercatinib →fda approvals ↗

›May 30, 2024approval803d agoBOSENTAN — FDA approvalZydus Therapeutics Inc

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

full page →fda approvals ↗

›May 30, 2024approval803d agoPREGABALIN — FDA approvalPREGABALIN

Sponsor: APOTEX. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →PREGABALIN →fda approvals ↗

›May 31, 2024approval802d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →ondansetron hydrochloride CR →fda approvals ↗

›May 31, 2024approval802d agoONDANSETRON — FDA approvalondansetron ODT

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

full page →ondansetron ODT →fda approvals ↗

›May 31, 2024approval802d agoONDANSETRON — FDA approvalondansetron ODT

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

full page →ondansetron ODT →fda approvals ↗

›May 31, 2024approval802d agoSIMLANDI (ADALIMUMAB-RYVK) — FDA approvalAlvotech

Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

798d ago

ALENDRONATE SODIUM — FDA approvalOrganon & Co.

Sponsor: IPCA LABS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jun 4, 2024approval798d agoIDACIO (ADALIMUMAB-AACF) — FDA approvalIDACIO

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →IDACIO →fda approvals ↗

›Jun 4, 2024approval798d agoJAYPIRCA (PIRTOBRUTINIB) — FDA approvalEli Lilly and Co

Sponsor: LOXO ONCOL. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jun 5, 2024approval797d agoCALQUENCE (ACALABRUTINIB MALEATE) — FDA approvalCALQUENCE

Sponsor: ASTRAZENECA. Form: TABLET. Route: ORAL

full page →CALQUENCE →fda approvals ↗

›Jun 5, 2024approval797d agoCALQUENCE (ACALABRUTINIB) — FDA approvalCALQUENCE

Sponsor: ASTRAZENECA. Form: CAPSULE. Route: ORAL

full page →CALQUENCE →fda approvals ↗

›Jun 5, 2024approval797d agoMEDROL (METHYLPREDNISOLONE) — FDA approvalMEDROL

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →MEDROL →fda approvals ↗

›Jun 5, 2024approval797d agoDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) — FDA approvalMETHYLPREDNISOLONE ACETATE

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →METHYLPREDNISOLONE ACETATE →fda approvals ↗

›Jun 5, 2024approval797d agoSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) — FDA approvalmethylprednisolone sodium succinate

Sponsor: PHARMACIA AND UPJOHN. Form: INJECTABLE. Route: INJECTION

full page →methylprednisolone sodium succinate →fda approvals ↗

›Jun 6, 2024approval796d agoRYTELO (IMETELSTAT SODIUM) — FDA approvalimetelstat sodium

Sponsor: GERON. Form: POWDER. Route: INTRAVENOUS

full page →imetelstat sodium →fda approvals ↗

›Jun 6, 2024approval796d agoLEQVIO (INCLISIRAN SODIUM) — FDA approvalinclisiran

Sponsor: NOVARTIS. Form: SOLUTION. Route: SUBCUTANEOUS

full page →inclisiran →fda approvals ↗

›Jun 7, 2024approval795d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

full page →pembrolizumab →fda approvals ↗

›Jun 7, 2024approval795d agoLEVORPHANOL TARTRATE — FDA approvalLEVORPHANOL TARTRATE

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

full page →LEVORPHANOL TARTRATE →fda approvals ↗

›Jun 7, 2024approval795d agoLEVORPHANOL TARTRATE — FDA approvalSpecGx LLC

Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

791d ago

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE (NOREPINEPHRINE BITARTRATE) — FDA approvalNOREPINEPHRINE BITARTRATE

Sponsor: BAXTER HLTHCARE CORP. Form: SOLUTION. Route: INTRAVENOUS

full page →NOREPINEPHRINE BITARTRATE →fda approvals ↗

›Jun 12, 2024approval790d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Jun 12, 2024approval790d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Jun 12, 2024approval790d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Jun 12, 2024approval790d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Jun 12, 2024approval790d agoLEVORPHANOL TARTRATE — FDA approvalLEVORPHANOL TARTRATE

Sponsor: NOVITIUM PHARMA. Form: TABLET. Route: ORAL

full page →LEVORPHANOL TARTRATE →fda approvals ↗

›Jun 12, 2024approval790d agoADBRY (TRALOKINUMAB) — FDA approvaltralokinumab

Sponsor: LEO PHARMA AS. Form: INJECTABLE. Route: INJECTION

full page →tralokinumab →fda approvals ↗

›Jun 12, 2024approval790d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL

full page →selpercatinib →fda approvals ↗

$AMGN417.20+1.52%

$ABBV247.97+0.78%

$PFE27.05+1.08%

$AMGN417.20+1.52%

$AZN161.91+0.30%

$PFE27.05+1.08%

$OGN13.62+0.15%

$ALVO3.7700-1.05%

$HROW40.70+0.64%

$HCWB

$LLY1231.94+3.90%

$AZN161.91+0.30%

$PFE27.05+1.08%

$LLY1231.94+3.90%

$GERN1.48000.00%

$NVS156.79+0.29%