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calendar

23,912 catalysts · 5,000 device 510k · 4,728 grant · 4,267 approval · 3,126 8k filing · 2,000 device pma · 2,000 device recall

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from 2024-01-05×clear all

type

device 510k5,000
grant4,728
approval4,267
8k filing3,126
device pma2,000
device recall2,000
recall1,126

device adverse event1,000

earnings583

phase 2 completion172

therapy area

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

Week of Jan 1, 2024

›Jan 5, 2024approval950d agoMETRONIDAZOLE — FDA approvalMETRONIDAZOLE

Sponsor: INNOGENIX. Form: TABLET. Route: ORAL

full page →METRONIDAZOLE →fda approvals ↗

›Jan 5, 2024approval950d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

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

full page →MYCOPHENOLATE MOFETIL →fda approvals ↗

›Jan 5, 2024approval950d agoIDACIO (ADALIMUMAB-AACF) — FDA approvalIDACIO

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →IDACIO →fda approvals ↗

›Jan 5, 2024approval950d agoTRAMADOL HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Week of Jan 8, 2024

›Jan 9, 2024approval946d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: MIKART. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Jan 10, 2024approval

Week of Jan 15, 2024

›Jan 16, 2024approval939d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

Sponsor: PH HEALTH. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Jan 16, 2024approval

Week of Jan 22, 2024

›Jan 24, 2024approval931d agoOZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jan 24, 2024approval

Week of Jan 29, 2024

›Jan 29, 2024approval926d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

›Jan 29, 2024approval

Week of Feb 5, 2024

›Feb 5, 2024approval919d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

›Feb 5, 2024approval

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page 1 of 479

945d ago

HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Jan 10, 2024approval945d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Jan 10, 2024approval945d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Jan 10, 2024approval945d agoBUTORPHANOL TARTRATE PRESERVATIVE FREE (BUTORPHANOL TARTRATE) — FDA approvalBUTORPHANOL TARTRATE

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →BUTORPHANOL TARTRATE →fda approvals ↗

›Jan 10, 2024approval945d agoBUTORPHANOL TARTRATE PRESERVATIVE FREE (BUTORPHANOL TARTRATE) — FDA approvalBUTORPHANOL TARTRATE

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →BUTORPHANOL TARTRATE →fda approvals ↗

›Jan 10, 2024approval945d agoBUTORPHANOL TARTRATE — FDA approvalBUTORPHANOL TARTRATE

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →BUTORPHANOL TARTRATE →fda approvals ↗

›Jan 10, 2024approval945d agoBUTORPHANOL TARTRATE — FDA approvalBUTORPHANOL TARTRATE

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →BUTORPHANOL TARTRATE →fda approvals ↗

›Jan 10, 2024approval945d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

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

full page →fda approvals ↗

›Jan 10, 2024approval945d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

›Jan 12, 2024approval943d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

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

full page →dupilumab →fda approvals ↗

›Jan 12, 2024approval943d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Jan 12, 2024approval943d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

›Jan 12, 2024approval943d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

939d ago

ZILBRYSQ (ZILUCOPLAN SODIUM) — FDA approvalzilucoplan

Sponsor: UCB INC. Form: SOLUTION. Route: SUBCUTANEOUS

full page →zilucoplan →fda approvals ↗

›Jan 16, 2024approval939d agoBUTORPHANOL TARTRATE — FDA approvalHospira Inc

Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Jan 16, 2024approval939d agoBUTORPHANOL TARTRATE — FDA approvalHospira Inc

Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Jan 16, 2024approval939d agoBUTORPHANOL TARTRATE — FDA approvalHospira Inc

Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Jan 16, 2024approval939d agoBUTORPHANOL TARTRATE — FDA approvalHospira Inc

Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Jan 19, 2024approval936d agoKESIMPTA (OFATUMUMAB) — FDA approvalKESIMPTA

Sponsor: NOVARTIS. Form: SOLUTION. Route: SUBCUTANEOUS

full page →KESIMPTA →fda approvals ↗

›Jan 19, 2024approval936d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

›Jan 19, 2024approval936d agoBALVERSA (ERDAFITINIB) — FDA approvalerdafitinib

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

full page →erdafitinib →fda approvals ↗

›Jan 19, 2024approval936d agoBALVERSA (ERDAFITINIB) — FDA approvalerdafitinib

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

full page →erdafitinib →fda approvals ↗

›Jan 19, 2024approval936d agoBALVERSA (ERDAFITINIB) — FDA approvalerdafitinib

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

full page →erdafitinib →fda approvals ↗

931d ago

TRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: PURACAP LABS BLU. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jan 24, 2024approval931d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: PURACAP LABS BLU. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jan 24, 2024approval931d agoKOSELUGO (SELUMETINIB SULFATE) — FDA approvalselumetinib sulfate

Sponsor: ASTRAZENECA. Form: CAPSULE. Route: ORAL

full page →selumetinib sulfate →fda approvals ↗

›Jan 25, 2024approval930d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

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

full page →dupilumab →fda approvals ↗

›Jan 25, 2024approval930d agoSKYCLARYS (OMAVELOXOLONE) — FDA approvalReata Pharmaceuticals Inc

Sponsor: BIOGEN US. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Jan 25, 2024approval930d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Jan 26, 2024approval929d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗

›Jan 26, 2024approval929d agoELUCIREM (GADOPICLENOL) — FDA approval

Sponsor: GUERBET. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

›Jan 26, 2024approval929d agoGADAVIST (GADOBUTROL) — FDA approval

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

full page →fda approvals ↗

926d ago

ISOTRETINOIN — FDA approvalISOTRETINOIN

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

full page →ISOTRETINOIN →fda approvals ↗

›Jan 30, 2024approval925d agoEOVIST (GADOXETATE DISODIUM) — FDA approval

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

full page →fda approvals ↗

›Jan 30, 2024approval925d agoLYBALVI (OLANZAPINE) — FDA approval(olanzapine + samidorphan l-malate)

Sponsor: ALKERMES INC. Form: TABLET. Route: ORAL

full page →(olanzapine + samidorphan l-malate) →fda approvals ↗

›Jan 31, 2024approval924d agoONDANSETRON — FDA approvalondansetron ODT

Sponsor: AUROBINDO PHARMA. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →ondansetron ODT →fda approvals ↗

›Jan 31, 2024approval924d agoONDANSETRON — FDA approvalondansetron ODT

Sponsor: AUROBINDO PHARMA. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →ondansetron ODT →fda approvals ↗

›Feb 1, 2024approval923d agoTRAMADOL HYDROCHLORIDE — FDA approvalGraviti Pharmaceuticals Inc

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

full page →fda approvals ↗

›Feb 1, 2024approval923d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

›Feb 1, 2024approval923d agoSERTRALINE HYDROCHLORIDE — FDA approvalSERTRALINE HYDROCHLORIDE

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

full page →SERTRALINE HYDROCHLORIDE →fda approvals ↗

919d ago

HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

$AMRX17.10-4.36%

$IGC0.2670+0.41%

$NVS155.21-1.01%

$ALKS49.21-0.38%

$REGN802.21-0.72%

$IGC0.2670+0.41%

$BMY63.75-1.68%

$AZN158.75-1.95%