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calendar

25,823 catalysts · 6,218 approval · 5,000 device 510k · 4,728 grant · 3,086 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

from 2022-01-21×clear all

type

approval6,218
device 510k5,000
grant4,728
8k filing3,086
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 Apr 25, 2022

›Apr 29, 2022approval1566d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

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

full page →fda approvals ↗

›Apr 29, 2022approval1566d agoNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (ETHINYL ESTRADIOL) — FDA approvalNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE →fda approvals ↗

›Apr 29, 2022approval1566d agoNORGESTIMATE AND ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) — FDA approvalNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Sponsor: MYLAN. Form: TABLET. Route: ORAL-28

full page →NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE →fda approvals ↗

›Apr 29, 2022approval1566d agoRINVOQ (UPADACITINIB) — FDA approvalupadacitinib tartrate ER

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

full page →upadacitinib tartrate ER →fda approvals ↗

Week of May 2, 2022

›May 3, 2022approval1562d 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 ↗

›May 3, 2022approval

Week of May 9, 2022

›May 9, 2022approval1556d agoVORICONAZOLE — FDA approvalVORICONAZOLE

Sponsor: MEITHEAL. Form: POWDER. Route: INTRAVENOUS

full page →VORICONAZOLE →fda approvals ↗

›May 10, 2022approval

Week of May 16, 2022

›May 16, 2022approval1549d agoESTRADIOL AND PROGESTERONE (ESTRADIOL) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

›May 18, 2022approval

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page 4 of 517

1562d ago

PREGABALIN — FDA approvalPREGABALIN

Sponsor: LUPIN LTD. Form: CAPSULE. Route: ORAL

full page →PREGABALIN →fda approvals ↗

›May 3, 2022approval1562d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›May 3, 2022approval1562d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›May 3, 2022approval1562d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: SUN PHARM. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

›May 3, 2022approval1562d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

›May 3, 2022approval1562d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

›May 3, 2022approval1562d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›May 3, 2022approval1562d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: SUN PHARM. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

›May 3, 2022approval1562d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›May 3, 2022approval1562d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›May 3, 2022approval1562d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›May 3, 2022approval1562d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: ALKEM LABS LTD. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

›May 3, 2022approval1562d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: PHARMOBEDIENT. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

›May 3, 2022approval1562d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›May 3, 2022approval1562d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

›May 3, 2022approval1562d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›May 3, 2022approval1562d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: BARR. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

›May 3, 2022approval1562d agoZUBSOLV (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalEdenbridge Pharmaceuticals LLC

Sponsor: EDENBRIDGE PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

›May 3, 2022approval1562d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: SPECGX LLC. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›May 3, 2022approval1562d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›May 3, 2022approval1562d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

›May 3, 2022approval1562d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›May 3, 2022approval1562d agoVOQUEZNA TRIPLE PAK (AMOXICILLIN) — FDA approvalamoxicillin + clarithromycin + vonoprazan

Sponsor: PHATHOM. Form: CAPSULE, TABLET, TABLET. Route: ORAL

full page →amoxicillin + clarithromycin + vonoprazan →fda approvals ↗

›May 3, 2022approval1562d agoVOQUEZNA DUAL PAK (AMOXICILLIN) — FDA approvalamoxicillin + vonoprazan fumarate

Sponsor: PHATHOM. Form: CAPSULE, TABLET. Route: ORAL

full page →amoxicillin + vonoprazan fumarate →fda approvals ↗

›May 4, 2022approval1561d agoPOMALIDOMIDE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›May 4, 2022approval1561d agoENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) — FDA approvaltrastuzumab deruxtecan

Sponsor: DAIICHI SANKYO. Form: INJECTABLE. Route: INJECTION

full page →trastuzumab deruxtecan →fda approvals ↗

›May 4, 2022approval1561d agoENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) — FDA approvaltrastuzumab deruxtecan

Sponsor: DAIICHI SANKYO. Form: INJECTABLE. Route: INJECTION

full page →trastuzumab deruxtecan →fda approvals ↗

›May 4, 2022approval1561d agoTAMSULOSIN HYDROCHLORIDE — FDA approvalTAMSULOSIN HYDROCHLORIDE

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

full page →TAMSULOSIN HYDROCHLORIDE →fda approvals ↗

›May 6, 2022approval1559d agoDOXIL (LIPOSOMAL) (DOXORUBICIN HYDROCHLORIDE) — FDA approvalDoxil

Sponsor: BAXTER HLTHCARE CORP. Form: INJECTABLE, LIPOSOMAL. Route: INJECTION

full page →Doxil →fda approvals ↗

1555d ago

VIGABATRIN — FDA approvalVIGABATRIN

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

full page →VIGABATRIN →fda approvals ↗

›May 10, 2022approval1555d agoMAGNESIUM SULFATE — FDA approvalMAGNESIUM SULFATE

Sponsor: BAXTER HLTHCARE CORP. Form: INJECTABLE. Route: INJECTION

full page →MAGNESIUM SULFATE →fda approvals ↗

›May 11, 2022approval1554d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗

›May 11, 2022approval1554d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›May 11, 2022approval1554d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

Sponsor: PHARMACYCLICS LLC. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›May 11, 2022approval1554d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

Sponsor: PHARMACYCLICS LLC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›May 13, 2022approval1552d agoMOUNJARO (TIRZEPATIDE) — FDA approvalZEPBOUND

Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →ZEPBOUND →fda approvals ↗

›May 13, 2022approval1552d agoNIZORAL ANTI-DANDRUFF (KETOCONAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: KRAMER. Form: SHAMPOO. Route: TOPICAL

full page →fda approvals ↗

›May 13, 2022approval1552d agoDIAMOX (ACETAZOLAMIDE) — FDA approvalAccord Healthcare Inc

Sponsor: TEVA BRANDED PHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

1547d ago

PANTOPRAZOLE SODIUM — FDA approvalPANTOPRAZOLE SODIUM

Sponsor: ASPIRO. Form: INJECTABLE. Route: INTRAVENOUS

full page →PANTOPRAZOLE SODIUM →fda approvals ↗

›May 19, 2022approval1546d agoEBANGA (ANSUVIMAB-ZYKL) — FDA approvalansuvimab

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

full page →ansuvimab →fda approvals ↗

›May 19, 2022approval1546d agoNEOSTIGMINE METHYLSULFATE — FDA approvalNEOSTIGMINE METHYLSULFATE

Sponsor: AMPHASTAR PHARMS INC. Form: SOLUTION. Route: INTRAVENOUS

full page →NEOSTIGMINE METHYLSULFATE →fda approvals ↗

›May 19, 2022approval1546d agoAMBRISENTAN — FDA approvalAMBRISENTAN

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →AMBRISENTAN →fda approvals ↗

›May 20, 2022approval1545d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

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

full page →dupilumab →fda approvals ↗

$IGC0.2670+0.41%

$ABBV247.97+0.78%

$AMRX17.47-2.29%

$IGC0.2670+0.41%

$INDV39.20+1.90%

$IGC0.2670+0.41%

$AMRX17.47-2.29%

$PHAT8.6500+0.93%

$AZN159.50-1.49%

$BMY64.84+0.19%

$ABBV247.97+0.78%

$LLY1223.99-0.64%

$AMPH20.14-0.81%

$REGN808.05+3.02%

$IGC0.2670+0.41%