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calendar

18,993 catalysts · 18,987 approval · 7,115 phase readout · 5,000 device 510k · 4,728 grant · 3,583 8k filing · 2,000 device pma

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soonest latest type sponsor alpha

type: filing×type: approval×clear all

type

approval18,987
phase readout7,115
device 510k5,000
grant4,728
8k filing3,583
device pma2,000
device recall

2,000

recall1,126

device adverse event1,000

earnings585

therapy area

Ophthalmology5

Week of Nov 4, 2024

›Nov 7, 2024approval660d agoDELSTRIGO (DORAVIRINE) — FDA approval(doravirine + lamivudine + tenofovir disoproxil fumarate)

Sponsor: MSD MERCK CO. Form: TABLET. Route: ORAL

full page →(doravirine + lamivudine + tenofovir disoproxil fumarate) →fda approvals ↗

›Nov 8, 2024approval659d agoOMEPRAZOLE — FDA approvalomeprazole DR

Sponsor: DEXCEL PHARMA. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →omeprazole DR →fda approvals ↗

Week of Nov 11, 2024

›Nov 12, 2024approval655d agoVONJO (PACRITINIB CITRATE) — FDA approvalpacritinib

Sponsor: SOBI. Form: CAPSULE. Route: ORAL

full page →pacritinib →fda approvals ↗

›Nov 13, 2024approval

Week of Nov 18, 2024

›Nov 19, 2024approval648d agoQSYMIA (PHENTERMINE HYDROCHLORIDE) — FDA approval(phentermine hydrochloride + topiramate) ER

Sponsor: VIVUS LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →(phentermine hydrochloride + topiramate) ER →fda approvals ↗

›Nov 19, 2024

Week of Nov 25, 2024

›Nov 25, 2024approval642d agoSUNLENCA (LENACAPAVIR SODIUM) — FDA approvallenacapavir sodium LA

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

full page →lenacapavir sodium LA →fda approvals ↗

›Nov 25, 2024approval

Week of Dec 2, 2024

›Dec 2, 2024approval635d agoTECVAYLI (TECLISTAMAB-CQYV) — FDA approvalteclistamab

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

full page →teclistamab →fda approvals ↗

›Dec 2, 2024approval

← prev

page 316 of 380

654d ago

SUNLENCA (LENACAPAVIR SODIUM) — FDA approvallenacapavir sodium LA

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

full page →lenacapavir sodium LA →fda approvals ↗

›Nov 13, 2024approval654d agoSUNLENCA (LENACAPAVIR SODIUM) — FDA approvallenacapavir sodium LA

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

full page →lenacapavir sodium LA →fda approvals ↗

›Nov 13, 2024approval654d agoCHILDREN'S ZYRTEC HIVES (CETIRIZINE HYDROCHLORIDE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

›Nov 14, 2024approval653d agoLEQEMBI (LECANEMAB-IRMB) — FDA approvallecanemab

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

full page →lecanemab →fda approvals ↗

›Nov 15, 2024approval652d agoSTELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

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

full page →fda approvals ↗

›Nov 15, 2024approval652d agoSTELARA (USTEKINUMAB) — FDA approvalustekinumab

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

full page →ustekinumab →fda approvals ↗

›Nov 15, 2024approval652d agoEPYSQLI (ECULIZUMAB-AAGH) — FDA approvalEPYSQLI

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

full page →EPYSQLI →fda approvals ↗

›Nov 15, 2024approval652d agoREVUFORJ (REVUMENIB CITRATE) — FDA approvalrevumenib citrate

Sponsor: SYNDAX. Form: TABLET. Route: ORAL

full page →revumenib citrate →fda approvals ↗

approval

648d ago

PAXLOVID (COPACKAGED) (NIRMATRELVIR) — FDA approvalPAXLOVID (COPACKAGED)

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →PAXLOVID (COPACKAGED) →fda approvals ↗

›Nov 20, 2024approval647d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Nov 20, 2024approval647d agoADRENACLICK (EPINEPHRINE) — FDA approvalViatris Inc

Sponsor: IMPAX. Form: INJECTABLE. Route: INTRAMUSCULAR, SUBCUTANEOUS

full page →fda approvals ↗

›Nov 20, 2024approval647d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: SANALUZ. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Nov 20, 2024approval647d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: SANALUZ. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Nov 21, 2024approval646d agoLICART (DICLOFENAC EPOLAMINE) — FDA approvalAmzell Limited

Sponsor: IBSA INST BIO. Form: SYSTEM. Route: TOPICAL

full page →fda approvals ↗

›Nov 21, 2024approval646d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

Sponsor: CUMBERLAND PHARMS. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

›Nov 21, 2024approval646d agoDICLOFENAC SODIUM — FDA approvalDICLOFENAC SODIUM

Sponsor: AUROBINDO PHARMA USA. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →DICLOFENAC SODIUM →fda approvals ↗

›Nov 21, 2024approval646d agoPONSTEL (MEFENAMIC ACID) — FDA approvalAvion Pharmaceuticals LLC

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

full page →fda approvals ↗

›Nov 21, 2024approval646d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

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

full page →Midol →fda approvals ↗

›Nov 21, 2024approval646d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalNovitium Pharma LLC

Sponsor: STEVENS J. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Nov 21, 2024approval646d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

Sponsor: BARR LABS INC. Form: TABLET. Route: ORAL

full page →Midol →fda approvals ↗

›Nov 21, 2024approval646d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalhydrocodone bitartrate ER

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

full page →hydrocodone bitartrate ER →fda approvals ↗

›Nov 21, 2024approval646d agoPERCODAN (ASPIRIN) — FDA approvalEndo Pharmaceuticals Inc

Sponsor: ENDO OPERATIONS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Nov 21, 2024approval646d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalANI PHARMACEUTICALS INC

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

full page →fda approvals ↗

›Nov 21, 2024approval646d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

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

full page →BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE →fda approvals ↗

›Nov 21, 2024approval646d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

Sponsor: ACTAVIS LABS FL INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Nov 21, 2024approval646d agoSYNALGOS-DC (ASPIRIN) — FDA approvalBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

Sponsor: SUN PHARM INDUSTRIES. Form: CAPSULE. Route: ORAL

full page →BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE →fda approvals ↗

›Nov 21, 2024approval646d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

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

full page →fda approvals ↗

›Nov 21, 2024approval646d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

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

full page →fda approvals ↗

›Nov 21, 2024approval646d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalhydrocodone bitartrate ER

Sponsor: AUROLIFE PHARMA LLC. Form: TABLET. Route: ORAL

full page →hydrocodone bitartrate ER →fda approvals ↗

›Nov 21, 2024approval646d agoCARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalCosette Pharmaceuticals Inc

Sponsor: INGENUS PHARMS NJ. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Nov 22, 2024approval645d agoTECVAYLI (TECLISTAMAB-CQYV) — FDA approvalteclistamab

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

full page →teclistamab →fda approvals ↗

›Nov 22, 2024approval645d agoRAPIBLYK (LANDIOLOL HYDROCHLORIDE) — FDA approvalAOP Health

Sponsor: AOP HLTH US. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

›Nov 22, 2024approval645d agoHYDROCODONE BITARTRATE AND ASPIRIN (ASPIRIN) — FDA approvalPurdue Pharma LP

Sponsor: LGM PHARMA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Nov 22, 2024approval645d agoLUNSUMIO (MOSUNETUZUMAB-AXGB) — FDA approvalmosunetuzumab

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

full page →mosunetuzumab →fda approvals ↗

›Nov 22, 2024approval645d agoVRAYLAR (CARIPRAZINE HYDROCHLORIDE) — FDA approvalCARIPRAZINE HYDROCHLORIDE

Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

full page →CARIPRAZINE HYDROCHLORIDE →fda approvals ↗

642d ago

SUNLENCA (LENACAPAVIR SODIUM) — FDA approvallenacapavir sodium LA

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

full page →lenacapavir sodium LA →fda approvals ↗

›Nov 26, 2024approval641d agoCHILDREN'S ZYRTEC HIVES (CETIRIZINE HYDROCHLORIDE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

›Nov 26, 2024approval641d agoRALDESY (TRAZODONE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: KAMAT. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

›Nov 27, 2024approval640d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

›Nov 29, 2024approval638d agoYESINTEK (USTEKINUMAB-KFCE) — FDA approvalustekinumab biosimilar

Sponsor: BIOCON BIOLOGICS INC. Form: INJECTABLE. Route: INJECTION

full page →ustekinumab biosimilar →fda approvals ↗

›Nov 29, 2024approval638d agoDAYTRANA (METHYLPHENIDATE) — FDA approvalNoven Pharmaceuticals Inc

Sponsor: NOVEN PHARMS INC. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fda approvals ↗

›Nov 29, 2024approval638d agoXELSTRYM (DEXTROAMPHETAMINE) — FDA approvalNoven Pharmaceuticals Inc

Sponsor: NOVEN PHARMS INC. Form: SYSTEM. Route: TRANSDERMAL

full page →fda approvals ↗

635d ago

TALVEY (TALQUETAMAB-TGVS) — FDA approvaltalquetamab

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

full page →talquetamab →fda approvals ↗

›Dec 2, 2024approval635d agoAXTLE (PEMETREXED DIPOTASSIUM) — FDA approvalAXTLE

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

full page →AXTLE →fda approvals ↗

$MRK153.10-2.14%

$GILD147.94-0.10%

$JNJ270.00-1.15%

$KVUE19.20-0.10%

$GILD147.94-0.10%

$VTRS16.94+0.53%

$PFE28.03-0.96%

$IGC0.2670+0.41%

$SNDX20.16+0.35%

$CPIX8.8650-1.17%

$IGC0.2670+0.41%

$BLNC

$ANIP73.85-0.95%

$ABBV259.04-1.47%

$GILD147.94-0.10%

$KVUE19.20-0.10%

$HCWB