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calendar

29,127 catalysts · 9,606 approval · 5,000 device 510k · 4,728 grant · 2,662 8k filing · 2,000 device pma · 2,000 device recall

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  • approval9,606
  • device 510k5,000
  • grant4,728
  • 8k filing2,662
  • 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 Apr 30, 2018

    6
    ›May 2, 2018approval3016d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

    Sponsor: AMNEAL PHARMS NY. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›May 2, 2018approval3016d agoZENATANE (ISOTRETINOIN) — FDA approvalISOTRETINOIN

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

    full page →ISOTRETINOIN →fda approvals ↗
    ›May 3, 2018approval3015d agoLITHIUM CARBONATE — FDA approvalCamber Pharmaceuticals Inc

    Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›May 3, 2018approval3015d agoLITHIUM CARBONATE — FDA approvalCamber Pharmaceuticals Inc

    Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›May 4, 2018approval3014d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Spexotras →fda approvals ↗
    ›May 4, 2018approval3014d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

    Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

    full page →dabrafenib mesylate ODT →fda approvals ↗

    Week of May 7, 2018

    5
    ›May 11, 2018approval3007d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

    Sponsor: IMMUNEX. Form: SYRINGE

    full page →fda approvals ↗
    ›May 11, 2018approval

    Week of May 14, 2018

    11
    ›May 14, 2018approval3004d agoMETHYLPREDNISOLONE — FDA approvalPFIZER INC

    Sponsor: TIANJIN TIANYAO. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›May 14, 2018approval

    Week of May 21, 2018

    7
    ›May 21, 2018approval2997d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

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

    full page →fda approvals ↗
    ›May 21, 2018approval

    Week of May 28, 2018

    3
    ›May 29, 2018approval2989d 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, 2018approval2983d 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

    6
    ›Jun 11, 2018approval2976d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

    Sponsor: BAYER. Form: TABLET. Route: ORAL

    full page →NAPROXEN SODIUM →fda approvals ↗
    ›Jun 11, 2018approval
    ← prev
    page 9 of 583
    next →
    3007d ago
    ACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

    full page →tocilizumab →fda approvals ↗
    ›May 11, 2018approval3007d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

    full page →tocilizumab →fda approvals ↗
    ›May 11, 2018approval3007d agoTRIUMEQ (ABACAVIR SULFATE) — FDA approvalViiV Healthcare Company

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

    full page →fda approvals ↗
    ›May 11, 2018approval3007d agoAZITHROMYCIN — FDA approvalPFIZER INC

    Sponsor: CHARTWELL RX. Form: FOR SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    3004d ago
    GABAPENTIN — FDA approvalGABAPENTIN

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

    full page →GABAPENTIN →fda approvals ↗
    ›May 14, 2018approval3004d agoSPINRAZA (NUSINERSEN SODIUM) — FDA approvalBIOGEN INC.

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

    full page →fda approvals ↗
    ›May 14, 2018approval3004d agoSPINRAZA (NUSINERSEN SODIUM) — FDA approvalBIOGEN INC.

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

    full page →fda approvals ↗
    ›May 14, 2018approval3004d agoTRANEXAMIC ACID — FDA approvalZydus Therapeutics Inc

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

    full page →fda approvals ↗
    ›May 14, 2018approval3004d agoONDANSETRON — FDA approvalSandoz Inc

    Sponsor: SUN PHARM INDS LTD. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →fda approvals ↗
    ›May 14, 2018approval3004d agoONDANSETRON — FDA approvalondansetron ODT

    Sponsor: SANDOZ. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →ondansetron ODT →fda approvals ↗
    ›May 15, 2018approval3003d agoOZURDEX (DEXAMETHASONE) — FDA approvaldexamethasone LA

    Sponsor: ABBVIE. Form: IMPLANT. Route: INTRAVITREAL

    full page →dexamethasone LA →fda approvals ↗
    ›May 17, 2018approval3001d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

    full page →tocilizumab →fda approvals ↗
    ›May 17, 2018approval3001d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

    full page →tocilizumab →fda approvals ↗
    ›May 18, 2018approval3000d agoANTARA (MICRONIZED) (FENOFIBRATE) — FDA approvalFENOFIBRATE

    Sponsor: LUPIN. Form: CAPSULE. Route: ORAL

    full page →FENOFIBRATE →fda approvals ↗
    2997d ago
    TOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

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

    full page →fda approvals ↗
    ›May 21, 2018approval2997d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

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

    full page →fda approvals ↗
    ›May 24, 2018approval2994d agoPALYNZIQ (PEGVALIASE-PQPZ) — FDA approvalBIOMARIN PHARMACEUTICAL INC

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

    full page →fda approvals ↗
    ›May 24, 2018approval2994d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

    full page →certolizumab pegol →fda approvals ↗
    ›May 25, 2018approval2993d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

    Sponsor: IMMUNEX. Form: SYRINGE

    full page →fda approvals ↗
    ›May 25, 2018approval2993d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

    Sponsor: IMMUNEX. Form: SYRINGE

    full page →fda approvals ↗
    2989d 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, 2018approval2988d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

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

    full page →fda approvals ↗
    2983d ago
    JUXTAPID (LOMITAPIDE MESYLATE) — FDA approvalChiesi USA Inc

    Sponsor: CHIESI. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Jun 6, 2018approval2981d agoPRED MILD (PREDNISOLONE ACETATE) — FDA approvalprednisolone acetate

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

    full page →prednisolone acetate →fda approvals ↗
    ›Jun 7, 2018approval2980d agoKINERET (ANAKINRA) — FDA approvalSobi Inc

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

    full page →fda approvals ↗
    ›Jun 8, 2018approval2979d agoSTELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

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

    full page →fda approvals ↗
    ›Jun 8, 2018approval2979d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

    Sponsor: BAYER. Form: TABLET. Route: ORAL

    full page →NAPROXEN SODIUM →fda approvals ↗
    ›Jun 8, 2018approval2979d agoVENCLEXTA (VENETOCLAX) — FDA approvalvenetoclax

    Sponsor: ABBVIE. Form: TABLET. Route: ORAL

    full page →venetoclax →fda approvals ↗
    ›Jun 8, 2018approval2979d agoVENCLEXTA (VENETOCLAX) — FDA approvalvenetoclax

    Sponsor: ABBVIE. Form: TABLET. Route: ORAL

    full page →venetoclax →fda approvals ↗
    ›Jun 8, 2018approval2979d 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, 2018approval2979d agoPROMETH VC W/ CODEINE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Jun 8, 2018approval2979d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Jun 8, 2018approval2979d agoESMOLOL HYDROCHLORIDE — FDA approvalESMOLOL HYDROCHLORIDE

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

    full page →ESMOLOL HYDROCHLORIDE →fda approvals ↗
    2976d ago
    SUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Jun 12, 2018approval2975d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›Jun 12, 2018approval2975d agoOMEPRAZOLE — FDA approvalomeprazole DR

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

    full page →omeprazole DR →fda approvals ↗
    ›Jun 13, 2018approval2974d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›Jun 13, 2018approval2974d agoCONTRAVE (BUPROPION HYDROCHLORIDE) — FDA approvalIpca Pharmaceuticals Inc

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

    full page →fda approvals ↗
    $PFE24.91-0.42%
    $GILD129.34-0.67%
    $AMGN377.50-1.99%
    $NVS153.49-1.70%
    $NVS153.49-1.70%
    $RDY12.04+1.60%
    $ABBV246.00-1.97%
    $BIIB201.31-0.81%
    $BIIB201.31-0.81%
    $PFE24.91-0.42%
    $BMRN60.06+0.07%
    $AMGN377.50-1.99%
    $ABBV246.00-1.97%
    $AMGN377.50-1.99%
    $ABBV246.00-1.97%
    $JNJ251.81-1.77%
    $ABBV246.00-1.97%
    $AMRX18.74+2.29%
    $INDV40.10-2.17%