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calendar

25,422 catalysts · 5,777 approval · 5,000 device 510k · 4,728 grant · 3,126 8k filing · 2,000 device pma · 2,000 device recall

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type

approval5,777
device 510k5,000
grant4,728
8k filing3,126
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

phase 2 completion172

therapy area

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

Week of Nov 21, 2022

1

›Nov 25, 2022approval1356d agoFENSOLVI KIT (LEUPROLIDE ACETATE) — FDA approvalLEUPROLIDE ACETATE

Sponsor: TOLMAR. Form: POWDER. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗

Week of Nov 28, 2022

6

›Nov 29, 2022approval1352d agoVORICONAZOLE — FDA approvalVORICONAZOLE

Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL

full page →VORICONAZOLE →fda approvals ↗

›Nov 29, 2022approval1352d agoVORICONAZOLE — FDA approvalVORICONAZOLE

Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL

full page →VORICONAZOLE →fda approvals ↗

›Nov 30, 2022approval1351d agoDATSCAN (IOFLUPANE I-123) — FDA approval

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

full page →fda approvals ↗

›Nov 30, 2022approval1351d agoBREXAFEMME (IBREXAFUNGERP CITRATE) — FDA approvalibrexafungerp citrate

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →ibrexafungerp citrate →fda approvals ↗

›Dec 2, 2022approval1349d agoQUDEXY XR (TOPIRAMATE) — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

Sponsor: UPSHER SMITH LABS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Dec 2, 2022approval1349d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

full page →atezolizumab →fda approvals ↗

Week of Dec 5, 2022

12

›Dec 5, 2022approval1346d agoBLINCYTO (BLINATUMOMAB) — FDA approvalblinatumomab

Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION

full page →blinatumomab →fda approvals ↗

›Dec 6, 2022approval

Week of Dec 12, 2022

31

›Dec 12, 2022approval1339d agoKRAZATI (ADAGRASIB) — FDA approvalBristol-Myers Squibb Co

Sponsor: BRISTOL. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Dec 13, 2022approval

page 5 of 509

1345d ago

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →fda approvals ↗

›Dec 6, 2022approval1345d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

Sponsor: CUMBERLAND PHARMS. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

›Dec 6, 2022approval1345d agoTEPEZZA (TEPROTUMUMAB-TRBW) — FDA approvalteprotumumab

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

full page →teprotumumab →fda approvals ↗

›Dec 6, 2022approval1345d agoWELLBUTRIN SR (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

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

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Dec 6, 2022approval1345d agoWELLBUTRIN (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Dec 7, 2022approval1344d agoTRIPTODUR KIT (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

Sponsor: AZURITY. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →triptorelin pamoate ER →fda approvals ↗

›Dec 8, 2022approval1343d agoACTIQ (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: CEPHALON. Form: TROCHE/LOZENGE. Route: TRANSMUCOSAL

full page →fda approvals ↗

›Dec 8, 2022approval1343d agoFENTORA (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: CEPHALON. Form: TABLET. Route: BUCCAL, SUBLINGUAL

full page →fda approvals ↗

›Dec 8, 2022approval1343d agoPRED MILD (PREDNISOLONE ACETATE) — FDA approvalprednisolone acetate

Sponsor: ABBVIE. Form: SUSPENSION/DROPS. Route: OPHTHALMIC

full page →prednisolone acetate →fda approvals ↗

›Dec 8, 2022approval1343d agoPRED MILD (PREDNISOLONE ACETATE) — FDA approvalprednisolone acetate

Sponsor: ABBVIE. Form: SUSPENSION/DROPS. Route: OPHTHALMIC

full page →prednisolone acetate →fda approvals ↗

›Dec 9, 2022approval1342d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

full page →atezolizumab →fda approvals ↗

1338d ago

IDACIO (ADALIMUMAB-AACF) — FDA approvalIDACIO

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

full page →IDACIO →fda approvals ↗

›Dec 13, 2022approval1338d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Dec 13, 2022approval1338d agoZEGERID OTC (OMEPRAZOLE) — FDA approvalCovis Pharmaceuticals Inc (Inactive)

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

full page →fda approvals ↗

›Dec 14, 2022approval1337d agoXELODA (CAPECITABINE) — FDA approvalArmas Pharmaceuticals Inc

Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Dec 14, 2022approval1337d agoXELODA (CAPECITABINE) — FDA approvalArmas Pharmaceuticals Inc

Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Dec 14, 2022approval1337d agoXELODA (CAPECITABINE) — FDA approvalArmas Pharmaceuticals Inc

Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Dec 14, 2022approval1337d agoXELODA (CAPECITABINE) — FDA approvalArmas Pharmaceuticals Inc

Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Dec 14, 2022approval1337d agoXELODA (CAPECITABINE) — FDA approvalArmas Pharmaceuticals Inc

Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Dec 14, 2022approval1337d agoXELODA (CAPECITABINE) — FDA approvalArmas Pharmaceuticals Inc

Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Dec 14, 2022approval1337d agoXELODA (CAPECITABINE) — FDA approvalArmas Pharmaceuticals Inc

Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Dec 14, 2022approval1337d agoXELODA (CAPECITABINE) — FDA approvalArmas Pharmaceuticals Inc

Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Dec 15, 2022approval1336d agoPEPCID AC (FAMOTIDINE) — FDA approvalKenvue Inc.

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

full page →fda approvals ↗

›Dec 15, 2022approval1336d agoVEKLURY (REMDESIVIR) — FDA approvalremdesivir

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

full page →remdesivir →fda approvals ↗

›Dec 16, 2022approval1335d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →fda approvals ↗

›Dec 16, 2022approval1335d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Dec 16, 2022approval1335d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: RUBICON RESEARCH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Dec 16, 2022approval1335d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Dec 16, 2022approval1335d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

›Dec 16, 2022approval1335d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Dec 16, 2022approval1335d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: RHODES PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

›Dec 16, 2022approval1335d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Dec 16, 2022approval1335d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

›Dec 16, 2022approval1335d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Dec 16, 2022approval1335d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: WES PHARMA INC. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Dec 16, 2022approval1335d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Dec 16, 2022approval1335d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: ALKEM LABS LTD. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

›Dec 16, 2022approval1335d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: PHARMOBEDIENT. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

›Dec 16, 2022approval1335d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Dec 16, 2022approval1335d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: RHODES PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

›Dec 16, 2022approval1335d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

$AMGN414.03-0.76%

$IGC0.2670+0.41%

$ABBV249.50+0.61%

$CPIX8.0500+3.34%

$GILD136.30+2.44%

$IGC0.2670+0.41%

$IGC0.2670+0.41%

$ABBV249.50+0.61%

$KVUE19.05+0.11%

$IGC0.2670+0.41%

$IGC0.2670+0.41%

$IGC0.2670+0.41%

$IGC0.2670+0.41%

$INDV38.43-0.10%

$IGC0.2670+0.41%

$IGC0.2670+0.41%