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calendar

29,167 catalysts · 9,636 approval · 5,000 device 510k · 4,728 grant · 3,012 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

from 2017-07-31×clear all

type

approval9,636
device 510k5,000
grant4,728
8k filing3,012
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

earnings577

phase 2 completion172

therapy area

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

Week of Nov 15, 2021

›Nov 19, 2021approval1726d agoOLANZAPINE — FDA approvalolanzapine ODT

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

full page →olanzapine ODT →fda approvals ↗

›Nov 19, 2021approval1726d agoOLANZAPINE — FDA approvalolanzapine ODT

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

full page →olanzapine ODT →fda approvals ↗

›Nov 19, 2021approval1726d agoOLANZAPINE — FDA approvalolanzapine ODT

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

full page →olanzapine ODT →fda approvals ↗

›Nov 19, 2021approval1726d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Week of Nov 22, 2021

›Nov 22, 2021approval1723d agoULTOMIRIS (RAVULIZUMAB-CWVZ) — FDA approvalAlexion Pharmaceuticals Inc

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

full page →fda approvals ↗

›Nov 23, 2021approval

Week of Nov 29, 2021

›Nov 30, 2021approval1715d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗

›Nov 30, 2021approval

Week of Dec 6, 2021

›Dec 7, 2021approval1708d agoEBANGA (ANSUVIMAB-ZYKL) — FDA approvalansuvimab

Sponsor: RIDGEBACK BIOTHERAPEUTICS. Form: POWDER. Route: IV (INFUSION)

full page →ansuvimab →fda approvals ↗

›Dec 8, 2021approval

Week of Dec 13, 2021

›Dec 13, 2021approval1702d agoNAPROXEN SODIUM — FDA approvalNAPROXEN SODIUM

Sponsor: BIONPHARMA. Form: CAPSULE. Route: ORAL

full page →NAPROXEN SODIUM →fda approvals ↗

›Dec 13, 2021approval

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page 67 of 584

1722d ago

INREBIC (FEDRATINIB HYDROCHLORIDE) — FDA approvalfedratinib

Sponsor: BRISTOL-MYERS. Form: CAPSULE. Route: ORAL

full page →fedratinib →fda approvals ↗

›Nov 23, 2021approval1722d agoLIVTENCITY (MARIBAVIR) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Nov 24, 2021approval1721d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

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

full page →fda approvals ↗

›Nov 24, 2021approval1721d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

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

full page →fda approvals ↗

›Nov 24, 2021approval1721d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

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

full page →fda approvals ↗

›Nov 24, 2021approval1721d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Nov 24, 2021approval1721d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: LANNETT CO INC. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Nov 26, 2021approval1719d agoATROPINE SULFATE — FDA approvalATROPINE SULFATE

Sponsor: APOTEX. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →ATROPINE SULFATE →fda approvals ↗

1715d ago

STAVZOR (VALPROIC ACID) — FDA approvalVALPROIC ACID

Sponsor: BIONPHARMA. Form: CAPSULE, DELAYED RELEASE. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗

›Nov 30, 2021approval1715d agoDEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗

›Nov 30, 2021approval1715d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗

›Nov 30, 2021approval1715d agoDARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ) — FDA approval(daratumumab + hyaluronidase (human recombinant))

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

full page →(daratumumab + hyaluronidase (human recombinant)) →fda approvals ↗

›Dec 1, 2021approval1714d agoEOVIST (GADOXETATE DISODIUM) — FDA approval

Sponsor: BAYER HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

›Dec 2, 2021approval1713d agoXELJANZ XR (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

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

full page →tofacitinib citrate ER →fda approvals ↗

›Dec 2, 2021approval1713d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

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

full page →fda approvals ↗

›Dec 2, 2021approval1713d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

Sponsor: PFIZER. Form: SOLUTION. Route: ORAL

full page →tofacitinib citrate ER →fda approvals ↗

›Dec 2, 2021approval1713d agoRINVOQ (UPADACITINIB) — FDA approvalupadacitinib tartrate ER

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

full page →upadacitinib tartrate ER →fda approvals ↗

›Dec 3, 2021approval1712d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Dec 3, 2021approval1712d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗

›Dec 3, 2021approval1712d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

›Dec 3, 2021approval1712d agoINREBIC (FEDRATINIB HYDROCHLORIDE) — FDA approvalfedratinib

Sponsor: BRISTOL-MYERS. Form: CAPSULE. Route: ORAL

full page →fedratinib →fda approvals ↗

›Dec 3, 2021approval1712d agoACTIQ (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: CEPHALON. Form: TROCHE/LOZENGE. Route: TRANSMUCOSAL

full page →fda approvals ↗

›Dec 3, 2021approval1712d agoFENTORA (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: CEPHALON. Form: TABLET. Route: BUCCAL, SUBLINGUAL

full page →fda approvals ↗

›Dec 4, 2021approval1711d agoCLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →CLEOCIN →fda approvals ↗

›Dec 4, 2021approval1711d agoCLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →CLEOCIN →fda approvals ↗

1707d ago

NURTEC ODT (RIMEGEPANT SULFATE) — FDA approvalrimegepant sulfate ODT

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

full page →rimegepant sulfate ODT →fda approvals ↗

›Dec 8, 2021approval1707d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalPrinston Pharmaceutical Inc

Sponsor: UNICHEM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Dec 8, 2021approval1707d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalPrinston Pharmaceutical Inc

Sponsor: UNICHEM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Dec 8, 2021approval1707d agoIRBESARTAN — FDA approvalIRBESARTAN

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

full page →IRBESARTAN →fda approvals ↗

›Dec 8, 2021approval1707d agoIRBESARTAN — FDA approvalIRBESARTAN

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

full page →IRBESARTAN →fda approvals ↗

1702d ago

BUPROPION HYDROCHLORIDE — FDA approvalSciegen Pharmaceuticals Inc

Sponsor: SCIEGEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Dec 13, 2021approval1702d agoBUPROPION HYDROCHLORIDE — FDA approvalSciegen Pharmaceuticals Inc

Sponsor: SCIEGEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Dec 13, 2021approval1702d agoBUPROPION HYDROCHLORIDE — FDA approvalSciegen Pharmaceuticals Inc

Sponsor: SCIEGEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Dec 14, 2021approval1701d agoCHILDREN'S ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL

full page →fda approvals ↗

›Dec 14, 2021approval1701d agoXELJANZ XR (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

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

full page →tofacitinib citrate ER →fda approvals ↗

›Dec 14, 2021approval1701d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

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

full page →fda approvals ↗

›Dec 14, 2021approval1701d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

Sponsor: PFIZER. Form: SOLUTION. Route: ORAL

full page →tofacitinib citrate ER →fda approvals ↗

›Dec 14, 2021approval1701d agoRINVOQ (UPADACITINIB) — FDA approvalupadacitinib tartrate ER

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

full page →upadacitinib tartrate ER →fda approvals ↗

›Dec 14, 2021approval1701d agoRINVOQ (UPADACITINIB) — FDA approvalupadacitinib tartrate ER

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

full page →upadacitinib tartrate ER →fda approvals ↗

›Dec 15, 2021approval1700d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: UPSHER SMITH LABS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Dec 15, 2021approval1700d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: UPSHER SMITH LABS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Dec 15, 2021approval1700d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: UPSHER SMITH LABS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

$ABBV245.40-0.26%

$INDV38.31-1.30%

$PFE27.00+0.90%

$ABBV245.40-0.26%

$BMY65.03+0.47%

$NVS156.22-0.07%

$BMY65.03+0.47%

$PFE27.00+0.90%

$KVUE19.05-0.94%

$PFE27.00+0.90%

$ABBV245.40-0.26%