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calendar

29,270 catalysts · 9,808 approval · 5,000 device 510k · 4,728 grant · 2,603 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

from 2017-05-02×clear all

type

approval9,808
device 510k5,000
grant4,728
8k filing2,603
device pma2,000
device recall2,000
recall1,126

device adverse event1,000

pdufa347

earnings311

therapy area

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

Week of Jul 3, 2017

›Jul 5, 2017approval3316d agoOMEPRAZOLE — FDA approvalomeprazole DR

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

full page →omeprazole DR →fda approvals ↗

›Jul 7, 2017approval3314d agoRECLAST (ZOLEDRONIC ACID) — FDA approvalZOLEDRONIC ACID

Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS

full page →ZOLEDRONIC ACID →fda approvals ↗

Week of Jul 10, 2017

›Jul 10, 2017approval3311d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

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

full page →fda approvals ↗

›Jul 11, 2017approval

Week of Jul 17, 2017

›Jul 17, 2017approval3304d agoTRANEXAMIC ACID — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Jul 17, 2017approval

Week of Jul 24, 2017

›Jul 24, 2017approval3297d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL

full page →enzalutamide →fda approvals ↗

›Jul 26, 2017approval

Week of Jul 31, 2017

›Jul 31, 2017approval3290d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗

›Jul 31, 2017approval

Week of Aug 7, 2017

›Aug 7, 2017approval3283d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

›Aug 8, 2017approval

Week of Aug 14, 2017

›Aug 14, 2017approval3276d agoBUTRANS (BUPRENORPHINE) — FDA approvalBUTRANS

Sponsor: PURDUE PHARMA LP. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →BUTRANS →fda approvals ↗

›Aug 14, 2017approval

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page 4 of 586

3310d ago

ENBREL (ETANERCEPT) — FDA approvalAMGEN INC

Sponsor: IMMUNEX. Form: SYRINGE

full page →fda approvals ↗

›Jul 11, 2017approval3310d agoBLINCYTO (BLINATUMOMAB) — FDA approvalblinatumomab

Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION

full page →blinatumomab →fda approvals ↗

›Jul 11, 2017approval3310d agoLUPRON (LEUPROLIDE ACETATE) — FDA approvalInvaGen Pharmaceuticals Inc

Sponsor: ABBVIE ENDOCRINE INC. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

›Jul 13, 2017approval3308d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

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

full page →guselkumab →fda approvals ↗

3304d ago

FLUOCINOLONE ACETONIDE — FDA approvalEclipse Life Sciences Inc

Sponsor: PADAGIS ISRAEL. Form: OIL/DROPS. Route: OTIC

full page →fda approvals ↗

›Jul 18, 2017approval3303d agoCEFUROXIME AXETIL — FDA approvalOrchid Pharma Inc

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

3295d ago

VICTOZA (LIRAGLUTIDE) — FDA approvalSaxenda

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

full page →Saxenda →fda approvals ↗

›Jul 27, 2017approval3294d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Jul 27, 2017approval3294d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Jul 27, 2017approval3294d agoABILIFY MAINTENA KIT (ARIPIPRAZOLE) — FDA approvalaripiprazole LA

Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →aripiprazole LA →fda approvals ↗

›Jul 27, 2017approval3294d agoPRALUENT (ALIROCUMAB) — FDA approvalalirocumab

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

full page →alirocumab →fda approvals ↗

›Jul 28, 2017approval3293d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

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

full page →fda approvals ↗

›Jul 28, 2017approval3293d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

›Jul 28, 2017approval3293d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

›Jul 28, 2017approval3293d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: MYLAN. Form: TABLET. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

›Jul 28, 2017approval3293d agoPROBUPHINE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: REACX PHARMS. Form: IMPLANT. Route: IMPLANTATION

full page →fda approvals ↗

›Jul 28, 2017approval3293d agoPROBUPHINE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: REACX PHARMS. Form: IMPLANT. Route: IMPLANTATION

full page →fda approvals ↗

3290d ago

KALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

full page →fda approvals ↗

›Jul 31, 2017approval3290d agoKALYDECO (IVACAFTOR) — FDA approvalivacaftor

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

full page →ivacaftor →fda approvals ↗

›Jul 31, 2017approval3290d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

Sponsor: RISING. Form: INJECTABLE. Route: INJECTION

full page →ondansetron hydrochloride CR →fda approvals ↗

›Jul 31, 2017approval3290d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Jul 31, 2017approval3290d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Aug 1, 2017approval3289d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

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

full page →dulaglutide →fda approvals ↗

›Aug 1, 2017approval3289d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

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

full page →dulaglutide →fda approvals ↗

›Aug 2, 2017approval3288d agoJUXTAPID (LOMITAPIDE MESYLATE) — FDA approvalChiesi USA Inc

Sponsor: CHIESI. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Aug 2, 2017approval3288d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

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

full page →fda approvals ↗

›Aug 3, 2017approval3287d agoVYXEOS (CYTARABINE) — FDA approvalMeitheal Pharmaceuticals Inc

Sponsor: JAZZ PHARMS THERAP. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

›Aug 3, 2017approval3287d agoQVAR REDIHALER (BECLOMETHASONE DIPROPIONATE) — FDA approvalSOLIGENIX, INC.

Sponsor: NORTON WATERFORD. Form: AEROSOL, METERED. Route: INHALATION

full page →fda approvals ↗

3282d ago

DILTIAZEM HYDROCHLORIDE — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Aug 10, 2017approval3280d agoFENTANYL-75 (FENTANYL) — FDA approvalDifGen Pharmaceuticals LLC

Sponsor: DIFGEN PHARMS. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fda approvals ↗

›Aug 10, 2017approval3280d agoFENTANYL-75 (FENTANYL) — FDA approvalDifGen Pharmaceuticals LLC

Sponsor: DIFGEN PHARMS. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fda approvals ↗

›Aug 10, 2017approval3280d agoGLYXAMBI (EMPAGLIFLOZIN) — FDA approval(empagliflozin + linagliptin)

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

full page →(empagliflozin + linagliptin) →fda approvals ↗

›Aug 10, 2017approval3280d agoGLYXAMBI (EMPAGLIFLOZIN) — FDA approval(empagliflozin + linagliptin)

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

full page →(empagliflozin + linagliptin) →fda approvals ↗

›Aug 11, 2017approval3279d agoWELLBUTRIN SR (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

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

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Aug 11, 2017approval3279d agoWELLBUTRIN (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Aug 12, 2017approval3278d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

Sponsor: CUBIST PHARMS LLC. Form: TABLET. Route: ORAL

full page →tedizolid phosphate →fda approvals ↗

›Aug 12, 2017approval3278d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

Sponsor: CUBIST PHARMS LLC. Form: TABLET. Route: ORAL

full page →tedizolid phosphate →fda approvals ↗

›Aug 12, 2017approval3278d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

Sponsor: CUBIST PHARMS LLC. Form: POWDER. Route: INTRAVENOUS

full page →tedizolid phosphate →fda approvals ↗

›Aug 12, 2017approval3278d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

Sponsor: CUBIST PHARMS LLC. Form: POWDER. Route: INTRAVENOUS

full page →tedizolid phosphate →fda approvals ↗

3276d ago

METFORMIN HYDROCHLORIDE — FDA approvalCenter for Biomedical Research for Neurodegenetive Diseases

Sponsor: GRANULES INDIA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Aug 14, 2017approval3276d agoMETFORMIN HYDROCHLORIDE — FDA approvalCenter for Biomedical Research for Neurodegenetive Diseases

Sponsor: GRANULES INDIA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Aug 15, 2017approval3275d agoOPILL (NORGESTREL) — FDA approvalHRA Pharma LLC

Sponsor: LABORATOIRE HRA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

$BMY65.31+0.69%

$ABBV250.94-2.51%

$AMGN385.16-0.64%

$REGN762.63+3.29%

$IGC0.2670+0.41%

$AMGN385.16-0.64%

$NVO47.08-8.78%

$IGC0.2670+0.41%

$VERX12.91+2.46%

$LLY1148.84-0.53%

$VERX12.91+2.46%

$LLY1148.84-0.53%

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