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calendar

25,774 catalysts · 6,075 approval · 5,000 device 510k · 4,728 grant · 3,180 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

from 2022-04-29×clear all

type

approval6,075
device 510k5,000
grant4,728
8k filing3,180
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

earnings584

phase 2 completion172

therapy area

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

Week of Mar 27, 2023

›Mar 30, 2023approval1232d agoZIPRASIDONE HYDROCHLORIDE — FDA approvalLupin Ltd

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

full page →fda approvals ↗

›Mar 31, 2023approval1231d agoPREZCOBIX (COBICISTAT) — FDA approvalGILEAD SCIENCES, INC.

Sponsor: JANSSEN PRODS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Mar 31, 2023approval1231d agoYUSIMRY (ADALIMUMAB-AQVH) — FDA approvalYUSIMRY

Sponsor: COHERUS BIOSCIENCES INC. Form: INJECTABLE. Route: INJECTION

full page →YUSIMRY →fda approvals ↗

Week of Apr 3, 2023

›Apr 3, 2023approval1228d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Apr 3, 2023approval

Week of Apr 10, 2023

›Apr 10, 2023approval1221d agoNISOLDIPINE — FDA approvalPrasco LLC

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

full page →fda approvals ↗

›Apr 10, 2023approval

Week of Apr 17, 2023

›Apr 17, 2023approval1214d agoVALACYCLOVIR HYDROCHLORIDE — FDA approvalVALACYCLOVIR HYDROCHLORIDE

Sponsor: JUBILANT GENERICS. Form: TABLET. Route: ORAL

full page →VALACYCLOVIR HYDROCHLORIDE →fda approvals ↗

›Apr 17, 2023approval

Week of Apr 24, 2023

›Apr 24, 2023approval1207d agoZEGERID OTC (OMEPRAZOLE) — FDA approvalCovis Pharmaceuticals Inc (Inactive)

Sponsor: RILEY CONSUMER. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Apr 25, 2023approval

Week of May 1, 2023

›May 1, 2023approval1200d agoDALFAMPRIDINE — FDA approvaldalfampridine ER

Sponsor: ACCORD HLTHCARE. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →dalfampridine ER →fda approvals ↗

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page 16 of 516

1228d ago

PADCEV (ENFORTUMAB VEDOTIN-EJFV) — FDA approvalenfortumab vedotin

Sponsor: ASTELLAS. Form: INJECTABLE. Route: INJECTION

full page →enfortumab vedotin →fda approvals ↗

›Apr 3, 2023approval1228d agoPADCEV (ENFORTUMAB VEDOTIN-EJFV) — FDA approvalenfortumab vedotin

Sponsor: ASTELLAS. Form: INJECTABLE. Route: INJECTION

full page →enfortumab vedotin →fda approvals ↗

›Apr 4, 2023approval1227d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

Sponsor: BAYER. Form: TABLET. Route: ORAL

full page →NAPROXEN SODIUM →fda approvals ↗

›Apr 4, 2023approval1227d agoACETAZOLAMIDE — FDA approvalACETAZOLAMIDE

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

full page →ACETAZOLAMIDE →fda approvals ↗

›Apr 4, 2023approval1227d agoNELARABINE — FDA approvalNELARABINE

Sponsor: AMNEAL. Form: INJECTABLE. Route: INTRAVENOUS

full page →NELARABINE →fda approvals ↗

›Apr 6, 2023approval1225d agoDILTIAZEM HYDROCHLORIDE — FDA approvalSciegen Pharmaceuticals Inc

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

full page →fda approvals ↗

›Apr 6, 2023approval1225d agoAMJEVITA (ADALIMUMAB-ATTO) — FDA approvalAMJEVITA

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

full page →AMJEVITA →fda approvals ↗

›Apr 7, 2023approval1224d agoATROPINE SULFATE — FDA approvalATROPINE SULFATE

Sponsor: ACCORD HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

full page →ATROPINE SULFATE →fda approvals ↗

1221d ago

RINVOQ (UPADACITINIB) — FDA approvalupadacitinib tartrate ER

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

full page →upadacitinib tartrate ER →fda approvals ↗

›Apr 13, 2023approval1218d agoCAPRELSA (VANDETANIB) — FDA approvalvandetanib

Sponsor: GENZYME CORP. Form: TABLET. Route: ORAL

full page →vandetanib →fda approvals ↗

›Apr 13, 2023approval1218d agoTEPEZZA (TEPROTUMUMAB-TRBW) — FDA approvalteprotumumab

Sponsor: HORIZON THERAPEUTICS IRELAND. Form: INJECTABLE. Route: INJECTION

full page →teprotumumab →fda approvals ↗

›Apr 14, 2023approval1217d agoRIZAFILM (RIZATRIPTAN BENZOATE) — FDA approvalNAL Pharmaceuticals Ltd

Sponsor: GENSCO. Form: FILM. Route: ORAL

full page →fda approvals ↗

›Apr 14, 2023approval1217d agoLUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: ABBVIE ENDOCRINE INC. Form: POWDER. Route: INTRAMUSCULAR

full page →fda approvals ↗

›Apr 14, 2023approval1217d agoHYRIMOZ (ADALIMUMAB-ADAZ) — FDA approvalHYRIMOZ

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

full page →HYRIMOZ →fda approvals ↗

1214d ago

VALACYCLOVIR HYDROCHLORIDE — FDA approvalVALACYCLOVIR HYDROCHLORIDE

Sponsor: JUBILANT GENERICS. Form: TABLET. Route: ORAL

full page →VALACYCLOVIR HYDROCHLORIDE →fda approvals ↗

›Apr 17, 2023approval1214d agoQULIPTA (ATOGEPANT) — FDA approvalatogepant

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →atogepant →fda approvals ↗

›Apr 18, 2023approval1213d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: ALKEM. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Apr 18, 2023approval1213d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: ALKEM. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Apr 18, 2023approval1213d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: ALKEM. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Apr 18, 2023approval1213d agoPADCEV (ENFORTUMAB VEDOTIN-EJFV) — FDA approvalenfortumab vedotin

Sponsor: ASTELLAS. Form: INJECTABLE. Route: INJECTION

full page →enfortumab vedotin →fda approvals ↗

›Apr 19, 2023approval1212d agoPOLIVY (POLATUZUMAB VEDOTIN-PIIQ) — FDA approvalpolatuzumab vedotin

Sponsor: GENENTECH. Form: POWDER. Route: INTRAVENOUS

full page →polatuzumab vedotin →fda approvals ↗

›Apr 20, 2023approval1211d agoBOSULIF (BOSUTINIB MONOHYDRATE) — FDA approvalAlembic Pharmaceuticals Inc

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

full page →fda approvals ↗

›Apr 20, 2023approval1211d agoSAXENDA (LIRAGLUTIDE) — FDA approvalNovo Nordisk Inc

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

›Apr 21, 2023approval1210d agoPEMETREXED DISODIUM — FDA approvalAlimta

Sponsor: SANDOZ. Form: SOLUTION. Route: INTRAVENOUS

full page →Alimta →fda approvals ↗

1206d ago

ISOVUE-250 (IOPAMIDOL) — FDA approval

Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Apr 25, 2023approval1206d agoISOVUE-370 (IOPAMIDOL) — FDA approval

Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Apr 26, 2023approval1205d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Apr 26, 2023approval1205d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Apr 26, 2023approval1205d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Apr 26, 2023approval1205d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Apr 26, 2023approval1205d agoZEJULA (NIRAPARIB TOSYLATE) — FDA approvalniraparib

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →niraparib →fda approvals ↗

›Apr 26, 2023approval1205d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

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

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

›Apr 26, 2023approval1205d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

Sponsor: VERTEX PHARMS INC. Form: GRANULES. Route: ORAL

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

›Apr 26, 2023approval1205d agoLIVTENCITY (MARIBAVIR) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Apr 26, 2023approval1205d agoHADLIMA (ADALIMUMAB-BWWD) — FDA approvalHADLIMA

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

full page →HADLIMA →fda approvals ↗

›Apr 26, 2023approval1205d agoPREGABALIN — FDA approvalPREGABALIN

Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL

full page →PREGABALIN →fda approvals ↗

›Apr 28, 2023approval1203d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: CARNEGIE. Form: TABLET. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

›Apr 28, 2023approval1203d agoSOGROYA (SOMAPACITAN-BECO) — FDA approvalsomatriptan albumin bound LA

Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS

full page →somatriptan albumin bound LA →fda approvals ↗

›Apr 28, 2023approval1203d agoLIBTAYO (CEMIPLIMAB-RWLC) — FDA approvalcemiplimab

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INTRAVENOUS

full page →cemiplimab →fda approvals ↗

›Apr 28, 2023approval1203d agoLIBTAYO (CEMIPLIMAB-RWLC) — FDA approvalcemiplimab

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INTRAVENOUS

full page →cemiplimab →fda approvals ↗

›Apr 28, 2023approval1203d agoUZEDY (RISPERIDONE) — FDA approvalDelpor Inc

Sponsor: TEVA. Form: SUSPENSION, EXTENDED RELEASE. Route: SUBCUTANEOUS

full page →fda approvals ↗

›Apr 28, 2023approval1203d agoVEKLURY (REMDESIVIR) — FDA approvalremdesivir

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

full page →remdesivir →fda approvals ↗

$GILD135.56-0.15%

$COGT38.58-0.32%

$AMRX17.52+2.43%

$AMGN416.31+0.48%

$RDY12.39-0.49%

$ABBV248.14-0.78%

$RDY12.39-0.49%

$VERX12.23+0.04%

$RDHL0.7390+6.64%

$VERX12.23+0.04%

$NVO46.20-2.06%

$REGN799.43+0.30%

$GILD135.56-0.15%