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calendar

28,223 catalysts · 17,796 approval · 4,110 device 510k · 2,473 grant · 1,581 device recall · 1,359 device pma · 904 recall

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  • approval17,796
  • device 510k4,110
  • grant2,473
  • device recall1,581
  • device pma1,359
  • recall904
therapy area

no tagged catalysts yet

Week of Jul 8, 2024

4
›Jul 11, 2024approval784d agoDEPO-SUBQ PROVERA 104 (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

Sponsor: PFIZER. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →medroxyprogesterone acetate →fda approvals ↗
›Jul 11, 2024approval784d agoDEPO-PROVERA (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →medroxyprogesterone acetate →fda approvals ↗
›Jul 11, 2024approval784d agoERTUGLIFLOZIN — FDA approvalERTUGLIFLOZIN

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

full page →ERTUGLIFLOZIN →fda approvals ↗
›Jul 12, 2024approval783d agoROBINUL (GLYCOPYRROLATE) — FDA approvalGLYCOPYRROLATE

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →GLYCOPYRROLATE →fda approvals ↗

Week of Jul 15, 2024

13
›Jul 15, 2024approval780d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

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

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗
›Jul 15, 2024approval780d agoDIVALPROEX SODIUM — FDA approvalUnichem Pharmaceuticals (USA) Inc

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

full page →fda approvals ↗
›Jul 16, 2024approval779d agoDILTIAZEM HYDROCHLORIDE — FDA approvalBausch Health US LLC

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

full page →fda approvals ↗
›Jul 16, 2024approval779d agoTOPIRAMATE — FDA approvaltopiramate ER

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

full page →topiramate ER →fda approvals ↗
›Jul 16, 2024approval779d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: SANDOZ. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗
›Jul 16, 2024approval779d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: SANDOZ. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗
›Jul 16, 2024approval779d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: SANDOZ. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗
›Jul 16, 2024approval779d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: SANDOZ. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗
›Jul 16, 2024approval779d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: SANDOZ. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗
›Jul 17, 2024approval778d agoSUNLENCA (LENACAPAVIR SODIUM) — FDA approvallenacapavir sodium LA

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

full page →lenacapavir sodium LA →fda approvals ↗
›Jul 17, 2024approval778d agoSUNLENCA (LENACAPAVIR SODIUM) — FDA approvallenacapavir sodium LA

Sponsor: GILEAD SCIENCES INC. Form: TABLET. Route: ORAL

full page →lenacapavir sodium LA →fda approvals ↗
›Jul 17, 2024approval778d agoVOQUEZNA (VONOPRAZAN FUMARATE) — FDA approvalvonoprazan fumarate

Sponsor: PHATHOM. Form: TABLET. Route: ORAL

full page →vonoprazan fumarate →fda approvals ↗
›Jul 19, 2024approval776d agoEPYSQLI (ECULIZUMAB-AAGH) — FDA approvalEPYSQLI

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

full page →EPYSQLI →fda approvals ↗

Week of Jul 22, 2024

11
›Jul 22, 2024approval773d agoMEROPENEM — FDA approvalMEROPENEM

Sponsor: QILU. Form: INJECTABLE. Route: INJECTION

full page →MEROPENEM →fda approvals ↗
›Jul 22, 2024approval773d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

Sponsor: IMMUNEX. Form: SYRINGE

full page →fda approvals ↗
›Jul 22, 2024approval773d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

Sponsor: IMMUNEX. Form: SYRINGE

full page →fda approvals ↗
›Jul 22, 2024approval773d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

Sponsor: IMMUNEX. Form: SYRINGE

full page →fda approvals ↗
›Jul 23, 2024approval772d agoELUCIREM (GADOPICLENOL) — FDA approval

Sponsor: GUERBET. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗
›Jul 23, 2024approval772d agoGADAVIST (GADOBUTROL) — FDA approval

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

full page →fda approvals ↗
›Jul 23, 2024approval772d agoEOVIST (GADOXETATE DISODIUM) — FDA approval

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

full page →fda approvals ↗
›Jul 24, 2024approval771d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

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

full page →fda approvals ↗
›Jul 24, 2024approval771d agoLACTATED RINGER'S IN PLASTIC CONTAINER (CALCIUM CHLORIDE) — FDA approvalCALCIUM CHLORIDE 10%

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

full page →CALCIUM CHLORIDE 10% →fda approvals ↗
›Jul 24, 2024approval771d agoVYVGART (EFGARTIGIMOD ALFA) — FDA approvalARGENX SE

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

full page →fda approvals ↗
›Jul 26, 2024approval769d agoCOPIKTRA (DUVELISIB) — FDA approvalSecura Bio Inc

Sponsor: SECURA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Week of Jul 29, 2024

11
›Jul 29, 2024approval766d agoCLEOCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) — FDA approvalclindamycin hydrochloride

Sponsor: PFIZER. Form: CAPSULE. Route: ORAL

full page →clindamycin hydrochloride →fda approvals ↗
›Jul 30, 2024approval765d agoINREBIC (FEDRATINIB HYDROCHLORIDE) — FDA approvalfedratinib

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

full page →fedratinib →fda approvals ↗
›Jul 30, 2024approval765d 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 ↗
›Jul 30, 2024approval765d agoORIAHNN (COPACKAGED) (ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE) — FDA approvalORIAHNN (COPACKAGED)

Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

full page →ORIAHNN (COPACKAGED) →fda approvals ↗
›Jul 30, 2024approval765d agoANTARA (MICRONIZED) (FENOFIBRATE) — FDA approvalFENOFIBRATE

Sponsor: LUPIN. Form: CAPSULE. Route: ORAL

full page →FENOFIBRATE →fda approvals ↗
›Jul 31, 2024approval764d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗
›Jul 31, 2024approval764d agoVOQUEZNA TRIPLE PAK (AMOXICILLIN) — FDA approvalamoxicillin + clarithromycin + vonoprazan

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

full page →amoxicillin + clarithromycin + vonoprazan →fda approvals ↗
›Jul 31, 2024approval764d agoVOQUEZNA DUAL PAK (AMOXICILLIN) — FDA approvalamoxicillin + vonoprazan fumarate

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

full page →amoxicillin + vonoprazan fumarate →fda approvals ↗
›Aug 1, 2024approval763d agoVENOFER (IRON SUCROSE) — FDA approvalInternational Medication Systems Ltd

Sponsor: AM REGENT. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗
›Aug 2, 2024approval762d agoERLEADA (APALUTAMIDE) — FDA approvalapalutamide

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

full page →apalutamide →fda approvals ↗
›Aug 2, 2024approval762d agoTRAMADOL HYDROCHLORIDE — FDA approvalGraviti Pharmaceuticals Inc

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

full page →fda approvals ↗

Week of Aug 5, 2024

10
›Aug 7, 2024approval757d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗
›Aug 7, 2024approval757d agoCREXONT (CARBIDOPA) — FDA approvalOrganon & Co.

Sponsor: IMPAX. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗
›Aug 7, 2024approval757d agoVALBENAZINE TOSYLATE — FDA approvalVALBENAZINE TOSYLATE

Sponsor: ZYDUS LIFESCIENCES. Form: CAPSULE. Route: ORAL

full page →VALBENAZINE TOSYLATE →fda approvals ↗
›Aug 7, 2024approval757d agoSCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approvalasciminib hydrochloride

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →asciminib hydrochloride →fda approvals ↗
›Aug 8, 2024approval756d agoVYVGART HYTRULO (EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC) — FDA approvalARGENX SE

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

full page →fda approvals ↗
›Aug 8, 2024approval756d agoVYVGART (EFGARTIGIMOD ALFA) — FDA approvalARGENX SE

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

full page →fda approvals ↗
›Aug 9, 2024approval755d agoNEFFY (EPINEPHRINE) — FDA approvalInternational Medication Systems Ltd

Sponsor: ARS PHARMS OPERATION. Form: SPRAY. Route: NASAL

full page →fda approvals ↗
›Aug 9, 2024approval755d agoENZEEVU (AFLIBERCEPT-ABZV) — FDA approvalaflibercept biosimilar

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

full page →aflibercept biosimilar →fda approvals ↗
›Aug 9, 2024approval755d agoFUROSCIX (FUROSEMIDE) — FDA approvalFurosemide Sun

Sponsor: SCPHARMACEUTICALS. Form: SOLUTION. Route: SUBCUTANEOUS

full page →Furosemide Sun →fda approvals ↗
›Aug 9, 2024approval755d agoYORVIPATH (PALOPEGTERIPARATIDE) — FDA approvalpalopegteriparatide

Sponsor: ASCENDIS PHARMA BONE. Form: SOLUTION. Route: SUBCUTANEOUS

full page →palopegteriparatide →fda approvals ↗

Week of Aug 12, 2024

1
›Aug 12, 2024approval752d agoSILIQ (BRODALUMAB) — FDA approvalBausch Health US LLC

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

full page →fda approvals ↗
← prev
page 306 of 565
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$PFE28.55+0.32%
$PFE28.55+0.32%
$PHAT9.3900-1.88%
$PFE28.55+0.32%
$GILD149.92+2.45%
$GILD149.92+2.45%
$AMGN438.12+1.92%
$AMGN438.12+1.92%
$AMGN438.12+1.92%
$AZN162.47+0.21%
$ARGX1045.22+1.62%
$BMY66.92+0.16%
$ABBV259.99+1.39%
$PHAT9.3900-1.88%
$PHAT9.3900-1.88%
$OGN13.760.00%
$ASND252.05-0.94%
$NVS161.25+6.04%
$ARGX1045.22+1.62%
$ARGX1045.22+1.62%