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29,144 catalysts · 9,584 approval · 5,000 device 510k · 4,728 grant · 2,701 8k filing · 2,000 device pma · 2,000 device recall

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  • approval9,584
  • device 510k5,000
  • grant4,728
  • 8k filing2,701
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • pdufa347
  • earnings323
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of May 21, 2018

    7
    ›May 21, 2018approval2998d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

    Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›May 21, 2018approval2998d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

    Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›May 21, 2018approval2998d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

    Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›May 24, 2018approval2995d agoPALYNZIQ (PEGVALIASE-PQPZ) — FDA approvalBIOMARIN PHARMACEUTICAL INC

    Sponsor: BIOMARIN PHARM. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›May 24, 2018approval2995d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

    full page →certolizumab pegol →fda approvals ↗
    ›May 25, 2018approval2994d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

    Sponsor: IMMUNEX. Form: SYRINGE

    full page →fda approvals ↗
    ›May 25, 2018approval2994d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

    Sponsor: IMMUNEX. Form: SYRINGE

    full page →fda approvals ↗

    Week of May 28, 2018

    3
    ›May 29, 2018approval2990d agoICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›May 29, 2018approval

    Week of Jun 4, 2018

    12
    ›Jun 4, 2018approval2984d agoPREZCOBIX (COBICISTAT) — FDA approvalGILEAD SCIENCES, INC.

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

    full page →fda approvals ↗
    ›Jun 4, 2018approval

    Week of Jun 11, 2018

    11
    ›Jun 11, 2018approval2977d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

    Sponsor: BAYER. Form: TABLET. Route: ORAL

    full page →NAPROXEN SODIUM →fda approvals ↗
    ›Jun 11, 2018approval

    Week of Jun 18, 2018

    14
    ›Jun 18, 2018approval2970d agoLEVORPHANOL TARTRATE — FDA approvalLEVORPHANOL TARTRATE

    Sponsor: HIKMA. Form: TABLET. Route: ORAL

    full page →LEVORPHANOL TARTRATE →fda approvals ↗
    ›Jun 19, 2018approval

    Week of Jun 25, 2018

    3
    ›Jun 26, 2018approval2962d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

    Sponsor: COSETTE. Form: SYRUP. Route: ORAL

    full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
    ›Jun 26, 2018
    ← prev
    page 9 of 583
    next →
    2990d ago
    NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (ETHINYL ESTRADIOL) — FDA approvalNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

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

    full page →NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE →fda approvals ↗
    ›May 30, 2018approval2989d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

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

    full page →fda approvals ↗
    2984d ago
    JUXTAPID (LOMITAPIDE MESYLATE) — FDA approvalChiesi USA Inc

    Sponsor: CHIESI. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Jun 6, 2018approval2982d agoPRED MILD (PREDNISOLONE ACETATE) — FDA approvalprednisolone acetate

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

    full page →prednisolone acetate →fda approvals ↗
    ›Jun 7, 2018approval2981d agoKINERET (ANAKINRA) — FDA approvalSobi Inc

    Sponsor: BIOVITRUM AB. Form: VIAL. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Jun 8, 2018approval2980d agoSTELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

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

    full page →fda approvals ↗
    ›Jun 8, 2018approval2980d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

    Sponsor: BAYER. Form: TABLET. Route: ORAL

    full page →NAPROXEN SODIUM →fda approvals ↗
    ›Jun 8, 2018approval2980d agoVENCLEXTA (VENETOCLAX) — FDA approvalvenetoclax

    Sponsor: ABBVIE. Form: TABLET. Route: ORAL

    full page →venetoclax →fda approvals ↗
    ›Jun 8, 2018approval2980d agoVENCLEXTA (VENETOCLAX) — FDA approvalvenetoclax

    Sponsor: ABBVIE. Form: TABLET. Route: ORAL

    full page →venetoclax →fda approvals ↗
    ›Jun 8, 2018approval2980d agoPROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›Jun 8, 2018approval2980d agoPROMETH VC W/ CODEINE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Jun 8, 2018approval2980d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Jun 8, 2018approval2980d agoESMOLOL HYDROCHLORIDE — FDA approvalESMOLOL HYDROCHLORIDE

    Sponsor: SAGENT PHARMS INC. Form: INJECTABLE. Route: INJECTION

    full page →ESMOLOL HYDROCHLORIDE →fda approvals ↗
    2977d ago
    SUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Jun 12, 2018approval2976d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›Jun 12, 2018approval2976d agoOMEPRAZOLE — FDA approvalomeprazole DR

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

    full page →omeprazole DR →fda approvals ↗
    ›Jun 13, 2018approval2975d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›Jun 13, 2018approval2975d agoCONTRAVE (BUPROPION HYDROCHLORIDE) — FDA approvalIpca Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Jun 14, 2018approval2974d 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 ↗
    ›Jun 14, 2018approval2974d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Jun 14, 2018approval2974d agoSTIVARGA (REGORAFENIB) — FDA approvalBayer AG

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

    full page →fda approvals ↗
    ›Jun 14, 2018approval2974d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

    full page →atezolizumab →fda approvals ↗
    ›Jun 14, 2018approval2974d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

    full page →certolizumab pegol →fda approvals ↗
    2969d ago
    COSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

    Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Jun 19, 2018approval2969d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›Jun 19, 2018approval2969d agoTOPAMAX SPRINKLE (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Jun 19, 2018approval2969d agoTOPAMAX (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Jun 19, 2018approval2969d agoPROMETHAZINE WITH CODEINE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Jun 19, 2018approval2969d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

    Sponsor: ACTAVIS MID ATLANTIC. Form: SYRUP. Route: ORAL

    full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
    ›Jun 19, 2018approval2969d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

    Sponsor: HIKMA. Form: SYRUP. Route: ORAL

    full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
    ›Jun 19, 2018approval2969d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

    full page →atezolizumab →fda approvals ↗
    ›Jun 21, 2018approval2967d agoVIGADRONE (VIGABATRIN) — FDA approvalVIGABATRIN

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

    full page →VIGABATRIN →fda approvals ↗
    ›Jun 21, 2018approval2967d agoULTIVA (REMIFENTANIL HYDROCHLORIDE) — FDA approvalremifentanil hydrochloride

    Sponsor: MYLAN INSTITUTIONAL. Form: INJECTABLE. Route: INJECTION

    full page →remifentanil hydrochloride →fda approvals ↗
    ›Jun 22, 2018approval2966d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›Jun 22, 2018approval2966d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›Jun 22, 2018approval2966d agoPROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

    Sponsor: HIKMA. Form: SYRUP. Route: ORAL

    full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
    approval
    2962d ago
    PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

    Sponsor: GENUS LIFESCIENCES. Form: SYRUP. Route: ORAL

    full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
    ›Jun 26, 2018approval2962d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

    full page →atezolizumab →fda approvals ↗
    $BMRN59.99-0.04%
    $AMGN378.87-1.63%
    $AMGN378.87-1.63%
    $GILD131.15+0.72%
    $JNJ254.41-0.76%
    $INDV40.10-2.17%
    $ABBV245.10-2.33%
    $ABBV245.10-2.33%
    $ABBV245.10-2.33%
    $AMRX18.85+2.89%
    $IGC0.2670+0.41%
    $NVS153.67-1.59%
    $AMRX18.85+2.89%
    $AMRX18.85+2.89%