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calendar

28,855 catalysts · 9,606 approval · 5,000 device 510k · 4,728 grant · 2,730 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

from 2017-08-21×clear all

type

approval9,606
device 510k5,000
grant4,728
8k filing2,730
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

earnings328

phase 2 completion172

therapy area

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

Week of Sep 17, 2018

›Sep 21, 2018approval2875d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

›Sep 21, 2018approval2875d agoOXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: PH HEALTH. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Week of Sep 24, 2018

›Sep 24, 2018approval2872d agoCOPIKTRA (DUVELISIB) — FDA approvalSecura Bio Inc

Sponsor: SECURA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Sep 24, 2018approval

Week of Oct 1, 2018

›Oct 3, 2018approval2863d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

Sponsor: IMMUNEX. Form: SYRINGE

full page →fda approvals ↗

›Oct 4, 2018approval

Week of Oct 8, 2018

›Oct 9, 2018approval2857d agoSILIQ (BRODALUMAB) — FDA approvalBausch Health US LLC

Sponsor: VALEANT LUXEMBOURG. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Oct 10, 2018approval

Week of Oct 15, 2018

›Oct 16, 2018approval2850d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Oct 16, 2018approval

Week of Oct 22, 2018

›Oct 23, 2018approval2843d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

›Oct 24, 2018approval

Week of Oct 29, 2018

›Oct 29, 2018approval2837d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: HIBROW HLTHCARE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Oct 29, 2018approval

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page 20 of 578

2872d ago

COPIKTRA (DUVELISIB) — FDA approvalSecura Bio Inc

Sponsor: SECURA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Sep 25, 2018approval2871d agoBENAZEPRIL HYDROCHLORIDE — FDA approvalBENAZEPRIL HYDROCHLORIDE

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

full page →BENAZEPRIL HYDROCHLORIDE →fda approvals ↗

›Sep 26, 2018approval2870d agoOXYCONTIN (OXYCODONE HYDROCHLORIDE) — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: PURDUE PHARMA LP. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

›Sep 26, 2018approval2870d agoAMPHETAMINE SULFATE — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

›Sep 28, 2018approval2868d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: IMPAX LABS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Sep 28, 2018approval2868d agoHUMIRA (ADALIMUMAB) — FDA approvaladalimumab

Sponsor: ABBVIE INC. Form: VIAL

full page →adalimumab →fda approvals ↗

›Sep 28, 2018approval2868d agoARIKAYCE KIT (AMIKACIN SULFATE) — FDA approvalamikacin sulfate PR

Sponsor: INSMED INC. Form: SUSPENSION, LIPOSOMAL. Route: INHALATION

full page →amikacin sulfate PR →fda approvals ↗

›Sep 28, 2018approval2868d agoLIBTAYO (CEMIPLIMAB-RWLC) — FDA approvalcemiplimab

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

full page →cemiplimab →fda approvals ↗

2862d ago

VFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

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

full page →fda approvals ↗

›Oct 5, 2018approval2861d agoPYLERA (BISMUTH SUBCITRATE POTASSIUM) — FDA approval

Sponsor: LABS JUVISE. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

2856d ago

SPINRAZA (NUSINERSEN SODIUM) — FDA approvalBIOGEN INC.

Sponsor: BIOGEN IDEC. Form: SOLUTION. Route: INTRATHECAL

full page →fda approvals ↗

›Oct 11, 2018approval2855d agoCHILDREN'S ZYRTEC HIVES (CETIRIZINE HYDROCHLORIDE) — FDA approvalKenvue Inc.

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

full page →fda approvals ↗

›Oct 12, 2018approval2854d agoCAPRELSA (VANDETANIB) — FDA approvalvandetanib

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

full page →vandetanib →fda approvals ↗

›Oct 12, 2018approval2854d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

2850d ago

HUMIRA (ADALIMUMAB) — FDA approvaladalimumab

Sponsor: ABBVIE INC. Form: VIAL

full page →adalimumab →fda approvals ↗

›Oct 16, 2018approval2850d agoGABAPENTIN — FDA approvalGABAPENTIN

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

full page →GABAPENTIN →fda approvals ↗

›Oct 16, 2018approval2850d agoOXALIPLATIN — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: NOVAST LABS. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

›Oct 17, 2018approval2849d agoVISINE (NAPHAZOLINE HYDROCHLORIDE) — FDA approval

Sponsor: KENVUE BRANDS. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →fda approvals ↗

›Oct 18, 2018approval2848d agoXELJANZ XR (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

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

full page →tofacitinib citrate ER →fda approvals ↗

›Oct 18, 2018approval2848d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

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

full page →fda approvals ↗

›Oct 18, 2018approval2848d agoBOSULIF (BOSUTINIB MONOHYDRATE) — FDA approvalAlembic Pharmaceuticals Inc

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

full page →fda approvals ↗

›Oct 18, 2018approval2848d agoICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Oct 19, 2018approval2847d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

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

full page →dupilumab →fda approvals ↗

›Oct 19, 2018approval2847d agoSAXENDA (LIRAGLUTIDE) — FDA approvalNovo Nordisk Inc

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

2842d ago

HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ALVOGEN. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Oct 24, 2018approval2842d agoIRBESARTAN — FDA approvalIRBESARTAN

Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL

full page →IRBESARTAN →fda approvals ↗

›Oct 25, 2018approval2841d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: ACTELION. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Oct 25, 2018approval2841d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: ACTELION. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

›Oct 25, 2018approval2841d agoAFREZZA (INSULIN RECOMBINANT HUMAN) — FDA approvalinsulin human

Sponsor: MANNKIND. Form: POWDER. Route: INHALATION

full page →insulin human →fda approvals ↗

›Oct 26, 2018approval2840d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Oct 26, 2018approval2840d agoXTAMPZA ER (OXYCODONE) — FDA approvaloxycodone ER

Sponsor: COLLEGIUM PHARM INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →oxycodone ER →fda approvals ↗

›Oct 26, 2018approval2840d agoSYNJARDY XR (EMPAGLIFLOZIN) — FDA approval(empagliflozin + metformin hydrochloride ER)

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →(empagliflozin + metformin hydrochloride ER) →fda approvals ↗

›Oct 26, 2018approval2840d agoGLYXAMBI (EMPAGLIFLOZIN) — FDA approval(empagliflozin + linagliptin)

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

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

›Oct 26, 2018approval2840d agoSYNJARDY (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

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

full page →SYNJARDY →fda approvals ↗

›Oct 26, 2018approval2840d agoJARDIANCE (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

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

full page →SYNJARDY →fda approvals ↗

›Oct 28, 2018approval2838d agoBIJUVA (ESTRADIOL) — FDA approval(estradiol + progesterone)

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

full page →(estradiol + progesterone) →fda approvals ↗

2837d ago

OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

›Oct 30, 2018approval2836d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Oct 30, 2018approval2836d agoDOXYCYCLINE HYCLATE — FDA approvalPolyPid Ltd.

Sponsor: HIKMA INTL PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Oct 30, 2018approval2836d agoHYRIMOZ (ADALIMUMAB-ADAZ) — FDA approvalHYRIMOZ

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

full page →HYRIMOZ →fda approvals ↗

›Oct 31, 2018approval2835d 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 ↗

›Oct 31, 2018approval2835d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

$IGC0.2670+0.41%

$AMRX18.48-1.96%

$AMGN390.02+2.94%

$INSM98.75+0.30%

$AMRX18.48-1.96%

$REGN760.66+0.19%

$ABBV243.80-0.53%

$AMRX18.48-1.96%

$BIIB208.45+3.29%

$KVUE19.55+2.84%

$IGC0.2670+0.41%

$ABBV243.80-0.53%

$PFE25.41+1.52%

$REGN760.66+0.19%

$MNKD3.9600+4.21%

$INDV40.10-2.17%

$COLL35.73+0.42%

$PYPD4.4500+2.06%

$IGC0.2670+0.41%