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calendar

29,251 catalysts · 18,044 approval · 4,307 device 510k · 2,688 grant · 1,777 device recall · 1,480 device pma · 955 recall

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  • approval18,044
  • device 510k4,307
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  • device recall1,777
  • device pma1,480
  • recall955
therapy area

no tagged catalysts yet

Week of Oct 17, 2022

9
›Oct 20, 2022approval1413d agoTOPAMAX SPRINKLE (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗
›Oct 20, 2022approval1413d agoTOPAMAX (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗
›Oct 20, 2022approval1413d agoPREZCOBIX (COBICISTAT) — FDA approvalGILEAD SCIENCES, INC.

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

full page →fda approvals ↗
›Oct 21, 2022approval1412d agoOMEPRAZOLE — FDA approvalomeprazole DR

Sponsor: DEXCEL. Form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE. Route: ORAL

full page →omeprazole DR →fda approvals ↗
›Oct 21, 2022approval1412d agoDEMEROL (MEPERIDINE HYDROCHLORIDE) — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗
›Oct 21, 2022approval1412d agoBYLVAY (ODEVIXIBAT) — FDA approvalodevixibat

Sponsor: IPSEN. Form: CAPSULE. Route: ORAL

full page →odevixibat →fda approvals ↗
›Oct 21, 2022approval1412d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Oct 21, 2022approval1412d agoVYEPTI (EPTINEZUMAB-JJMR) — FDA approvalH. Lundbeck AS

Sponsor: Lundbeck Seattle BioPharmaceuticals, Inc.. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Oct 21, 2022approval1412d agoRINVOQ (UPADACITINIB) — FDA approvalupadacitinib tartrate ER

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

full page →upadacitinib tartrate ER →fda approvals ↗

Week of Oct 24, 2022

15
›Oct 24, 2022approval1409d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: AMNEAL. Form: TABLET. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗
›Oct 24, 2022approval1409d agoIGALMI (DEXMEDETOMIDINE HYDROCHLORIDE) — FDA approvaldexmedetomidine

Sponsor: BIOXCEL. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →dexmedetomidine →fda approvals ↗
›Oct 24, 2022approval1409d agoVEKLURY (REMDESIVIR) — FDA approvalremdesivir

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

full page →remdesivir →fda approvals ↗
›Oct 25, 2022approval1408d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: GRANULES. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗
›Oct 25, 2022approval1408d agoTECVAYLI (TECLISTAMAB-CQYV) — FDA approvalteclistamab

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

full page →teclistamab →fda approvals ↗
›Oct 25, 2022approval1408d agoATORVASTATIN CALCIUM — FDA approvalSciegen Pharmaceuticals Inc

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

full page →fda approvals ↗
›Oct 26, 2022approval1407d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

Sponsor: ALKEM LABS LTD. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗
›Oct 26, 2022approval1407d agoEPRONTIA (TOPIRAMATE) — FDA approvaltopiramate ER

Sponsor: AZURITY. Form: SOLUTION. Route: ORAL

full page →topiramate ER →fda approvals ↗
›Oct 27, 2022approval1406d agoVIGABATRIN — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Oct 27, 2022approval1406d agoVIGABATRIN — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗
›Oct 28, 2022approval1405d agoVIGABATRIN — FDA approvalInvaGen Pharmaceuticals Inc

Sponsor: INVAGEN PHARMS. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗
›Oct 28, 2022approval1405d agoVIGABATRIN — FDA approvalInvaGen Pharmaceuticals Inc

Sponsor: INVAGEN PHARMS. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗
›Oct 28, 2022approval1405d agoXYZAL ALLERGY 24HR (LEVOCETIRIZINE DIHYDROCHLORIDE) — FDA approvalSanofi

Sponsor: CHATTEM SANOFI. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗
›Oct 28, 2022approval1405d agoPADCEV (ENFORTUMAB VEDOTIN-EJFV) — FDA approvalenfortumab vedotin

Sponsor: ASTELLAS. Form: INJECTABLE. Route: INJECTION

full page →enfortumab vedotin →fda approvals ↗
›Oct 28, 2022approval1405d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

Sponsor: AMNEAL. Form: SOLUTION. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗

Week of Oct 31, 2022

8
›Nov 1, 2022approval1401d agoDATSCAN (IOFLUPANE I-123) — FDA approval

Sponsor: GE HLTHCARE INC. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗
›Nov 1, 2022approval1401d agoLANSOPRAZOLE — FDA approvallansoprazole DR

Sponsor: DEXCEL. Form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE. Route: ORAL

full page →lansoprazole DR →fda approvals ↗
›Nov 1, 2022approval1401d agoZEGERID OTC (OMEPRAZOLE) — FDA approvalCovis Pharmaceuticals Inc (Inactive)

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

full page →fda approvals ↗
›Nov 1, 2022approval1401d agoIRBESARTAN — FDA approvalIRBESARTAN

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

full page →IRBESARTAN →fda approvals ↗
›Nov 2, 2022approval1400d agoDARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ) — FDA approval(daratumumab + hyaluronidase (human recombinant))

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

full page →(daratumumab + hyaluronidase (human recombinant)) →fda approvals ↗
›Nov 2, 2022approval1400d agoLANOXIN PEDIATRIC (DIGOXIN) — FDA approvalDIGOXIN

Sponsor: AZURITY. Form: INJECTABLE. Route: INJECTION

full page →DIGOXIN →fda approvals ↗
›Nov 4, 2022approval1398d agoENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) — FDA approvaltrastuzumab deruxtecan

Sponsor: DAIICHI SANKYO. Form: INJECTABLE. Route: INJECTION

full page →trastuzumab deruxtecan →fda approvals ↗
›Nov 4, 2022approval1398d agoRYBREVANT (AMIVANTAMAB-VMJW) — FDA approvalamivantamab

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

full page →amivantamab →fda approvals ↗

Week of Nov 7, 2022

12
›Nov 8, 2022approval1394d agoVIGABATRIN — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗
›Nov 8, 2022approval1394d agoVIGABATRIN — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗
›Nov 8, 2022approval1394d agoVIGABATRIN — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗
›Nov 8, 2022approval1394d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →carbamazepine ER →fda approvals ↗
›Nov 8, 2022approval1394d agoERLEADA (APALUTAMIDE) — FDA approvalapalutamide

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

full page →apalutamide →fda approvals ↗
›Nov 8, 2022approval1394d agoERLEADA (APALUTAMIDE) — FDA approvalapalutamide

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

full page →apalutamide →fda approvals ↗
›Nov 8, 2022approval1394d agoLIBTAYO (CEMIPLIMAB-RWLC) — FDA approvalcemiplimab

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

full page →cemiplimab →fda approvals ↗
›Nov 9, 2022approval1393d agoZTALMY (GANAXOLONE) — FDA approvalganaxolone

Sponsor: IMMEDICA PHARMA. Form: SUSPENSION. Route: ORAL

full page →ganaxolone →fda approvals ↗
›Nov 9, 2022approval1393d agoZTALMY (GANAXOLONE) — FDA approvalganaxolone

Sponsor: IMMEDICA PHARMA. Form: SUSPENSION. Route: ORAL

full page →ganaxolone →fda approvals ↗
›Nov 10, 2022approval1392d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Nov 13, 2022approval1389d agoDAPTOMYCIN — FDA approvalDaptomycin Novo

Sponsor: MEITHEAL. Form: POWDER. Route: INTRAVENOUS

full page →Daptomycin Novo →fda approvals ↗
›Nov 13, 2022approval1389d agoDAPTOMYCIN — FDA approvalDaptomycin Novo

Sponsor: MEITHEAL. Form: POWDER. Route: INTRAVENOUS

full page →Daptomycin Novo →fda approvals ↗

Week of Nov 14, 2022

6
›Nov 15, 2022approval1387d agoBUDESONIDE — FDA approvalbudesonide DR

Sponsor: RISING. Form: CAPSULE, DELAYED RELEASE. Route: ORAL

full page →budesonide DR →fda approvals ↗
›Nov 15, 2022approval1387d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: WES PHARMA INC. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗
›Nov 16, 2022approval1386d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: SUN PHARM. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗
›Nov 16, 2022approval1386d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: SUN PHARM. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗
›Nov 16, 2022approval1386d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: PHARMOBEDIENT. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗
›Nov 17, 2022approval1385d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

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

full page →dulaglutide →fda approvals ↗
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$AMRX17.47-0.40%
$AMRX17.47-0.40%
$GILD148.94+1.78%
$ABBV260.49+1.59%
$BTAI0.9215-10.53%
$AZN162.13-0.35%
$GILD148.94+1.78%
$AMRX17.47-0.40%
$SNY44.44+0.18%
$AMRX17.47-0.40%
$AMRX17.47-0.40%
$REGN820.40+2.67%
$IGC0.2670+0.41%
$IGC0.2670+0.41%
$AZN162.13-0.35%
$IGC0.2670+0.41%
$LLY1171.08+1.24%
$IGC0.2670+0.41%