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calendar

29,794 catalysts · 18,165 approval · 4,368 device 510k · 2,977 grant · 1,806 device recall · 1,519 device pma · 959 recall

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  • approval18,165
  • device 510k4,368
  • grant2,977
  • device recall1,806
  • device pma1,519
  • recall959
therapy area

no tagged catalysts yet

Week of Aug 12, 2024

16
›Aug 13, 2024approval751d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

Sponsor: STRIDES PHARMA INTL. Form: FOR SUSPENSION. Route: ORAL

full page →MYCOPHENOLATE MOFETIL →fda approvals ↗
›Aug 13, 2024approval751d agoDILTIAZEM HYDROCHLORIDE — FDA approvalBausch Health US LLC

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

full page →fda approvals ↗
›Aug 13, 2024approval751d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

Sponsor: AMNEAL. Form: FOR SUSPENSION. Route: ORAL

full page →MYCOPHENOLATE MOFETIL →fda approvals ↗
›Aug 13, 2024approval751d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

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

full page →MYCOPHENOLATE MOFETIL →fda approvals ↗
›Aug 13, 2024approval751d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

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

full page →MYCOPHENOLATE MOFETIL →fda approvals ↗
›Aug 13, 2024approval751d agoMYCOPHENOLATE SODIUM — FDA approvalmycophenolate sodium DR

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

full page →mycophenolate sodium DR →fda approvals ↗
›Aug 13, 2024approval751d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗
›Aug 13, 2024approval751d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: HIKMA. Form: SYRUP. Route: ORAL

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗
›Aug 14, 2024approval750d agoELUCIREM (GADOPICLENOL) — FDA approval

Sponsor: GUERBET. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗
›Aug 14, 2024approval750d agoEOVIST (GADOXETATE DISODIUM) — FDA approval

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

full page →fda approvals ↗
›Aug 14, 2024approval750d agoLIVDELZI (SELADELPAR LYSINE) — FDA approvalseladelpar lysine

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

full page →seladelpar lysine →fda approvals ↗
›Aug 15, 2024approval749d agoCHILDREN'S ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL

full page →fda approvals ↗
›Aug 15, 2024approval749d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

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

full page →fda approvals ↗
›Aug 16, 2024approval748d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Aug 16, 2024approval748d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Aug 16, 2024approval748d agoYUFLYMA (ADALIMUMAB-AATY) — FDA approvalYUFLYMA

Sponsor: CELLTRION. Form: INJECTABLE. Route: INJECTION

full page →YUFLYMA →fda approvals ↗

Week of Aug 19, 2024

17
›Aug 19, 2024approval745d agoBOSENTAN — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

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

full page →fda approvals ↗
›Aug 19, 2024approval745d agoBOSENTAN — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

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

full page →fda approvals ↗
›Aug 19, 2024approval745d agoAMBRISENTAN — FDA approvalAMBRISENTAN

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

full page →AMBRISENTAN →fda approvals ↗
›Aug 19, 2024approval745d agoAMBRISENTAN — FDA approvalAMBRISENTAN

Sponsor: SIGMAPHARM LABS LLC. Form: TABLET. Route: ORAL

full page →AMBRISENTAN →fda approvals ↗
›Aug 19, 2024approval745d agoAMBRISENTAN — FDA approvalSigmapharm Laboratories LLC

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

full page →fda approvals ↗
›Aug 19, 2024approval745d agoLAZCLUZE (LAZERTINIB MESYLATE) — FDA approvallazertinib mesylate

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

full page →lazertinib mesylate →fda approvals ↗
›Aug 19, 2024approval745d agoRYBREVANT (AMIVANTAMAB-VMJW) — FDA approvalamivantamab

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

full page →amivantamab →fda approvals ↗
›Aug 19, 2024approval745d agoIFOSFAMIDE — FDA approvalIFOSFAMIDE

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

full page →IFOSFAMIDE →fda approvals ↗
›Aug 19, 2024approval745d agoIFOSFAMIDE — FDA approvalIFOSFAMIDE

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

full page →IFOSFAMIDE →fda approvals ↗
›Aug 19, 2024approval745d agoAMBRISENTAN — FDA approvalAMBRISENTAN

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →AMBRISENTAN →fda approvals ↗
›Aug 20, 2024approval744d agoAMJEVITA (ADALIMUMAB-ATTO) — FDA approvalAMJEVITA

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

full page →AMJEVITA →fda approvals ↗
›Aug 22, 2024approval742d agoBEYFORTUS (NIRSEVIMAB-ALIP) — FDA approvalnirsevimab

Sponsor: ASTRAZENECA AB. Form: INJECTABLE. Route: INJECTION

full page →nirsevimab →fda approvals ↗
›Aug 22, 2024approval742d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗
›Aug 22, 2024approval742d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗
›Aug 22, 2024approval742d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗
›Aug 22, 2024approval742d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗
›Aug 22, 2024approval742d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Week of Aug 26, 2024

15
›Aug 26, 2024approval738d agoDOXYCYCLINE — FDA approvaldoxycycline ER

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

full page →doxycycline ER →fda approvals ↗
›Aug 26, 2024approval738d agoDOXYCYCLINE — FDA approvaldoxycycline ER

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

full page →doxycycline ER →fda approvals ↗
›Aug 26, 2024approval738d agoDOXYCYCLINE — FDA approvaldoxycycline ER

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

full page →doxycycline ER →fda approvals ↗
›Aug 26, 2024approval738d agoDOXYCYCLINE — FDA approvaldoxycycline ER

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

full page →doxycycline ER →fda approvals ↗
›Aug 26, 2024approval738d agoDOXYCYCLINE — FDA approvaldoxycycline ER

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

full page →doxycycline ER →fda approvals ↗
›Aug 26, 2024approval738d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗
›Aug 26, 2024approval738d agoSIMLANDI (ADALIMUMAB-RYVK) — FDA approvalAlvotech

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

full page →fda approvals ↗
›Aug 26, 2024approval738d agoSIMLANDI (ADALIMUMAB-RYVK) — FDA approvalAlvotech

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

full page →fda approvals ↗
›Aug 27, 2024approval737d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

Sponsor: HOSPIRA. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗
›Aug 27, 2024approval737d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

Sponsor: HOSPIRA. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗
›Aug 27, 2024approval737d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

Sponsor: HOSPIRA. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗
›Aug 27, 2024approval737d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

Sponsor: HOSPIRA. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗
›Aug 28, 2024approval736d agoACTIQ (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: CEPHALON. Form: TROCHE/LOZENGE. Route: TRANSMUCOSAL

full page →fda approvals ↗
›Aug 28, 2024approval736d agoFENTORA (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: CEPHALON. Form: TABLET. Route: BUCCAL, SUBLINGUAL

full page →fda approvals ↗
›Aug 30, 2024approval734d agoSEVOFLURANE — FDA approvalSEVOFLURANE

Sponsor: BAXTER HLTHCARE. Form: LIQUID. Route: INHALATION

full page →SEVOFLURANE →fda approvals ↗

Week of Sep 2, 2024

2
›Sep 4, 2024approval729d agoTRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

full page →OXCARBAZEPINE →fda approvals ↗
›Sep 4, 2024approval729d agoTRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →OXCARBAZEPINE →fda approvals ↗
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$GILD149.92+2.45%
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$ALVO5.3450+2.00%
$ALVO5.3450+2.00%
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