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calendar

23,532 catalysts · 5,000 device 510k · 4,728 grant · 3,928 approval · 3,085 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

from 2024-04-18×clear all

type

device 510k5,000
grant4,728
approval3,928
8k filing3,085
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

earnings583

phase 2 completion172

therapy area

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

Week of Jun 17, 2024

›Jun 21, 2024approval782d agoKRAZATI (ADAGRASIB) — FDA approvalBristol-Myers Squibb Co

Sponsor: BRISTOL. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jun 21, 2024approval782d agoVYVGART HYTRULO (EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC) — FDA approvalARGENX SE

Sponsor: ARGENX BV. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Jun 21, 2024approval782d agoVYVGART HYTRULO (EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC) — FDA approvalARGENX SE

Sponsor: ARGENX BV. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Jun 21, 2024approval782d agoWAKIX (PITOLISANT HYDROCHLORIDE) — FDA approvalpitolisant hydrochloride

Sponsor: HARMONY. Form: TABLET. Route: ORAL

full page →pitolisant hydrochloride →fda approvals ↗

Week of Jun 24, 2024

›Jun 24, 2024approval779d agoAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN) — FDA approvalamoxicillin

Sponsor: SANDOZ INC. Form: FOR SUSPENSION. Route: ORAL

full page →amoxicillin →fda approvals ↗

›Jun 25, 2024approval

Week of Jul 1, 2024

›Jul 2, 2024approval771d agoTECVAYLI (TECLISTAMAB-CQYV) — FDA approvalteclistamab

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

full page →teclistamab →fda approvals ↗

›Jul 2, 2024approval

Week of Jul 8, 2024

›Jul 8, 2024approval765d agoMETRONIDAZOLE — FDA approvalMETRONIDAZOLE

Sponsor: INNOGENIX. Form: TABLET. Route: ORAL

full page →METRONIDAZOLE →fda approvals ↗

›Jul 8, 2024approval

Week of Jul 15, 2024

›Jul 15, 2024approval758d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

›Jul 15, 2024approval

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page 4 of 471

778d ago

VANFLYTA (QUIZARTINIB DIHYDROCHLORIDE) — FDA approvalquizartinib dihydrochloride

Sponsor: DAIICHI SANKYO INC. Form: TABLET. Route: ORAL

full page →quizartinib dihydrochloride →fda approvals ↗

›Jun 25, 2024approval778d agoTEPYLUTE (THIOTEPA) — FDA approvalSTI Pharma LLC

Sponsor: SHORLA. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

›Jun 26, 2024approval777d agoEPKINLY (EPCORITAMAB-BYSP) — FDA approvalepcoritamab

Sponsor: GENMAB US, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →epcoritamab →fda approvals ↗

›Jun 26, 2024approval777d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

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

full page →fda approvals ↗

›Jun 26, 2024approval777d agoONDANSETRON — FDA approvalSandoz Inc

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

full page →fda approvals ↗

›Jun 26, 2024approval777d agoONDANSETRON — FDA approvalSandoz Inc

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

full page →fda approvals ↗

›Jun 26, 2024approval777d agoSIMLANDI (ADALIMUMAB-RYVK) — FDA approvalAlvotech

Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Jun 27, 2024approval776d agoVEKLURY (REMDESIVIR) — FDA approvalremdesivir

Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: INTRAVENOUS

full page →remdesivir →fda approvals ↗

›Jun 28, 2024approval775d agoABSORICA (ISOTRETINOIN) — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: SUN PHARM INDS INC. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Jun 28, 2024approval775d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

full page →PYZCHIVA →fda approvals ↗

›Jun 28, 2024approval775d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →PYZCHIVA →fda approvals ↗

›Jun 28, 2024approval775d agoHADLIMA (ADALIMUMAB-BWWD) — FDA approvalHADLIMA

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

full page →HADLIMA →fda approvals ↗

›Jun 28, 2024approval775d agoAXTLE (PEMETREXED DIPOTASSIUM) — FDA approvalAXTLE

Sponsor: AVYXA HOLDINGS. Form: POWDER. Route: INTRAVENOUS

full page →AXTLE →fda approvals ↗

›Jun 28, 2024approval775d agoULTOMIRIS (RAVULIZUMAB-CWVZ) — FDA approvalAlexion Pharmaceuticals Inc

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

full page →fda approvals ↗

771d ago

TALVEY (TALQUETAMAB-TGVS) — FDA approvaltalquetamab

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

full page →talquetamab →fda approvals ↗

›Jul 2, 2024approval771d agoSILIQ (BRODALUMAB) — FDA approvalBausch Health US LLC

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

full page →fda approvals ↗

›Jul 3, 2024approval770d agoVABYSMO (FARICIMAB-SVOA) — FDA approvalfaricimab

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

full page →faricimab →fda approvals ↗

›Jul 5, 2024approval768d agoXeomin (incobotulinumtoxinA) — FDA approvalMerz Pharmaceuticals LLC

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

full page →fda approvals ↗

›Jul 5, 2024approval768d agoNIZORAL ANTI-DANDRUFF (KETOCONAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: KRAMER. Form: SHAMPOO. Route: TOPICAL

full page →fda approvals ↗

765d ago

GABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: LAURUS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jul 8, 2024approval765d agoPYLERA (BISMUTH SUBCITRATE POTASSIUM) — FDA approval

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

full page →fda approvals ↗

›Jul 8, 2024approval765d agoCALCIUM CHLORIDE 10% (CALCIUM CHLORIDE) — FDA approvalCALCIUM CHLORIDE 10%

Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION

full page →CALCIUM CHLORIDE 10% →fda approvals ↗

›Jul 9, 2024approval764d agoERLEADA (APALUTAMIDE) — FDA approvalapalutamide

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

full page →apalutamide →fda approvals ↗

›Jul 9, 2024approval764d agoZORYVE (ROFLUMILAST) — FDA approvalArcutis Biotherapeutics, Inc.

Sponsor: ARCUTIS. Form: CREAM. Route: TOPICAL

full page →fda approvals ↗

›Jul 10, 2024approval763d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗

›Jul 10, 2024approval763d agoCEREZYME (IMIGLUCERASE) — FDA approvalimiglucerase

Sponsor: GENZYME. Form: INJECTABLE. Route: INJECTION

full page →imiglucerase →fda approvals ↗

›Jul 10, 2024approval763d agoELELYSO (TALIGLUCERASE ALFA) — FDA approvaltaliglucerase alfa

Sponsor: PFIZER. Form: POWDER. Route: INTRAVENOUS

full page →taliglucerase alfa →fda approvals ↗

›Jul 11, 2024approval762d agoMEKINIST (TRAMETINIB) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

full page →Spexotras →fda approvals ↗

›Jul 11, 2024approval762d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

›Jul 11, 2024approval762d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗

›Jul 11, 2024approval762d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

›Jul 11, 2024approval762d agoBOSENTAN — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

›Jul 11, 2024approval762d agoBOSENTAN — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

›Jul 11, 2024approval762d agoIBANDRONATE SODIUM — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: AVET LIFESCIENCES. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

›Jul 11, 2024approval762d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

Sponsor: APOTEX. Form: INJECTABLE. Route: INTRAVENOUS

full page →IBANDRONATE SODIUM →fda approvals ↗

›Jul 11, 2024approval762d agoAMONDYS 45 (CASIMERSEN) — FDA approvalcasimersen

Sponsor: SAREPTA THERAPS INC. Form: SOLUTION. Route: INTRAVENOUS

full page →casimersen →fda approvals ↗

›Jul 11, 2024approval762d agoDEPO-SUBQ PROVERA 104 (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

Sponsor: PFIZER. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →medroxyprogesterone acetate →fda approvals ↗

›Jul 11, 2024approval762d agoDEPO-PROVERA (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →medroxyprogesterone acetate →fda approvals ↗

›Jul 11, 2024approval762d agoERTUGLIFLOZIN — FDA approvalERTUGLIFLOZIN

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

full page →ERTUGLIFLOZIN →fda approvals ↗

›Jul 12, 2024approval761d agoROBINUL (GLYCOPYRROLATE) — FDA approvalGLYCOPYRROLATE

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →GLYCOPYRROLATE →fda approvals ↗

758d ago

DIVALPROEX SODIUM — FDA approvalUnichem Pharmaceuticals (USA) Inc

Sponsor: SUN PHARM INDS. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →fda approvals ↗

›Jul 16, 2024approval757d agoDILTIAZEM HYDROCHLORIDE — FDA approvalBausch Health US LLC

Sponsor: ACTAVIS LABS FL INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

$HRMY39.00+1.54%

$ARGX866.11+0.12%

$NVS156.79+0.29%

$ARQT25.92+2.49%

$ALVO3.7700-1.05%

$GILD133.06-0.11%

$AMRX17.88-1.43%

$NVS156.79+0.29%

$PFE27.05+1.08%

$AMRX17.88-1.43%

$NVS156.79+0.29%

$AMRX17.88-1.43%

$PFE27.05+1.08%

$RDY12.15-0.57%

$SRPT17.18+2.38%

$PFE27.05+1.08%