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calendar

29,050 catalysts · 9,524 approval · 5,000 device 510k · 4,728 grant · 2,667 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

from 2017-08-31×clear all

type

approval9,524
device 510k5,000
grant4,728
8k filing2,667
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

pdufa347

earnings317

therapy area

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

Week of Jan 29, 2018

›Feb 1, 2018approval3106d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Feb 2, 2018approval3105d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Week of Feb 5, 2018

›Feb 7, 2018approval3100d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

Sponsor: PHARMOBEDIENT. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

›Feb 9, 2018approval

Week of Feb 12, 2018

›Feb 12, 2018approval3095d agoSYMDEKO (COPACKAGED) (IVACAFTOR) — FDA approvalivacaftor

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

full page →ivacaftor →fda approvals ↗

›Feb 12, 2018approval

Week of Feb 19, 2018

›Feb 21, 2018approval3086d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

Sponsor: CHARTWELL MOLECULAR. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

›Feb 21, 2018approval

Week of Feb 26, 2018

›Feb 26, 2018approval3081d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

Sponsor: DR REDDYS LABS LTD. Form: TABLET. Route: ORAL

full page →ondansetron hydrochloride CR →fda approvals ↗

›Feb 26, 2018approval

Week of Mar 5, 2018

›Mar 5, 2018approval3074d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗

›Mar 5, 2018approval

← prev

page 5 of 581

3098d ago

OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

›Feb 9, 2018approval3098d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

3095d ago

GLATOPA (GLATIRAMER ACETATE) — FDA approvalGLATIRAMER ACETATE

Sponsor: SANDOZ. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →GLATIRAMER ACETATE →fda approvals ↗

›Feb 13, 2018approval3094d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗

›Feb 14, 2018approval3093d agoERLEADA (APALUTAMIDE) — FDA approvalapalutamide

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

full page →apalutamide →fda approvals ↗

›Feb 15, 2018approval3092d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗

›Feb 15, 2018approval3092d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗

›Feb 16, 2018approval3091d agoSTELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Feb 16, 2018approval3091d agoENTYVIO (VEDOLIZUMAB) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Feb 16, 2018approval3091d agoISOVUE-370 (IOPAMIDOL) — FDA approval

Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Feb 16, 2018approval3091d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

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

full page →fda approvals ↗

›Feb 16, 2018approval3091d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

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

full page →fda approvals ↗

›Feb 16, 2018approval3091d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

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

full page →fda approvals ↗

3086d ago

ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

Sponsor: CHARTWELL MOLECULAR. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

›Feb 21, 2018approval3086d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

3081d ago

ONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

Sponsor: DR REDDYS LABS LTD. Form: TABLET. Route: ORAL

full page →ondansetron hydrochloride CR →fda approvals ↗

›Feb 26, 2018approval3081d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

Sponsor: DR REDDYS LABS LTD. Form: TABLET. Route: ORAL

full page →ondansetron hydrochloride CR →fda approvals ↗

›Feb 26, 2018approval3081d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Feb 28, 2018approval3079d agoOMEPRAZOLE — FDA approvalomeprazole DR

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

full page →omeprazole DR →fda approvals ↗

›Mar 1, 2018approval3078d agoIOPIDINE (APRACLONIDINE HYDROCHLORIDE) — FDA approvalHARROW, INC.

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

full page →fda approvals ↗

›Mar 1, 2018approval3078d agoIOPIDINE (APRACLONIDINE HYDROCHLORIDE) — FDA approvalHARROW, INC.

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

full page →fda approvals ↗

›Mar 1, 2018approval3078d agoDEPO-SUBQ PROVERA 104 (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

Sponsor: PFIZER. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →medroxyprogesterone acetate →fda approvals ↗

3074d ago

OPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗

›Mar 5, 2018approval3074d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗

›Mar 5, 2018approval3074d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗

›Mar 5, 2018approval3074d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗

›Mar 5, 2018approval3074d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗

›Mar 5, 2018approval3074d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗

›Mar 5, 2018approval3074d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗

›Mar 5, 2018approval3074d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗

›Mar 5, 2018approval3074d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗

›Mar 5, 2018approval3074d agoSUBLOCADE (BUPRENORPHINE) — FDA approvalbuprenorphine LA

Sponsor: INDIVIOR. Form: SOLUTION, EXTENDED RELEASE. Route: SUBCUTANEOUS

full page →buprenorphine LA →fda approvals ↗

›Mar 6, 2018approval3073d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

Sponsor: ABBVIE. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

›Mar 6, 2018approval3073d agoDEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗

›Mar 6, 2018approval3073d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗

›Mar 6, 2018approval3073d agoALDACTONE (SPIRONOLACTONE) — FDA approvalALDACTONE

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →ALDACTONE →fda approvals ↗

›Mar 6, 2018approval3073d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Mar 7, 2018approval3072d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

›Mar 7, 2018approval3072d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

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

full page →ondansetron hydrochloride CR →fda approvals ↗

›Mar 7, 2018approval3072d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

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

full page →ondansetron hydrochloride CR →fda approvals ↗

›Mar 7, 2018approval3072d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →ondansetron hydrochloride CR →fda approvals ↗

›Mar 7, 2018approval3072d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →ondansetron hydrochloride CR →fda approvals ↗

›Mar 7, 2018approval3072d agoONDANSETRON — FDA approvalondansetron ODT

Sponsor: AUROBINDO PHARMA. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →ondansetron ODT →fda approvals ↗

$RDY12.07+1.86%

$BMY65.47+0.24%

$VERX13.40+3.80%

$BMY65.47+0.24%

$ABBV245.10-2.33%

$AZN157.97-6.88%

$ABBV245.10-2.33%

$JNJ254.41-0.76%

$RDY12.07+1.86%

$HROW39.09+0.83%

$BMY65.47+0.24%

$HROW39.09+0.83%

$PFE25.03+0.08%

$BMY65.47+0.24%

$INDV40.10-2.17%

$BMY65.47+0.24%

$ABBV245.10-2.33%

$RDHL0.7390+6.64%

$ABBV245.10-2.33%

$PFE25.03+0.08%