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calendar

4,011 catalysts · 4,728 grant · 3,912 device 510k · 3,080 8k filing · 3,076 approval · 2,000 device pma · 2,000 device recall

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type: approval×type: recall×from 2025-01-24×clear all

type

grant4,728
device 510k3,912
8k filing3,080
approval3,076
device pma2,000
device recall2,000

device adverse event

1,000

recall935

earnings583

phase 2 completion172

therapy area

no tagged catalysts yet

Week of Jan 20, 2025

›Jan 24, 2025approval565d agoMEKINIST (TRAMETINIB) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

full page →Spexotras →fda approvals ↗

›Jan 24, 2025approval565d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗

›Jan 24, 2025approval565d agoLEQEMBI (LECANEMAB-IRMB) — FDA approvallecanemab

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

full page →lecanemab →fda approvals ↗

›Jan 24, 2025approval565d agoAVTOZMA (TOCILIZUMAB-ANOH) — FDA approvalAVTOZMA

Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INTRAVENOUS

full page →AVTOZMA →fda approvals ↗

›Jan 26, 2025approval563d agoNIZORAL ANTI-DANDRUFF (KETOCONAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: KRAMER. Form: SHAMPOO. Route: TOPICAL

full page →fda approvals ↗

Week of Jan 27, 2025

›Jan 27, 2025approval562d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

Sponsor: TORRENT PHARMS. Form: TABLET, CHEWABLE. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

›Jan 27, 2025approval

Week of Feb 3, 2025

›Feb 3, 2025approval555d agoVALPROIC ACID — FDA approvalCereno Scientific AB

Sponsor: CHARTWELL RX. Form: SYRUP. Route: ORAL

full page →fda approvals ↗

›Feb 4, 2025approval

Week of Feb 10, 2025

›Feb 10, 2025approval548d agoENZEEVU (AFLIBERCEPT-ABZV) — FDA approvalaflibercept biosimilar

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

full page →aflibercept biosimilar →fda approvals ↗

›Feb 11, 2025approval

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562d ago

CARBAMAZEPINE — FDA approvalcarbamazepine ER

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

full page →carbamazepine ER →fda approvals ↗

›Jan 27, 2025approval562d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

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

full page →carbamazepine ER →fda approvals ↗

›Jan 27, 2025approval562d agoENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) — FDA approvaltrastuzumab deruxtecan

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

full page →trastuzumab deruxtecan →fda approvals ↗

›Jan 27, 2025approval562d agoENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) — FDA approvaltrastuzumab deruxtecan

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

full page →trastuzumab deruxtecan →fda approvals ↗

›Jan 28, 2025approval561d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Jan 28, 2025approval561d agoEPYSQLI (ECULIZUMAB-AAGH) — FDA approvalEPYSQLI

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

full page →EPYSQLI →fda approvals ↗

›Jan 28, 2025approval561d agoOZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

›Jan 29, 2025approval560d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

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

full page →fda approvals ↗

›Jan 29, 2025approval560d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

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

full page →fda approvals ↗

›Jan 29, 2025approval560d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

›Jan 29, 2025approval560d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

›Jan 29, 2025approval560d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

›Jan 29, 2025approval560d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Jan 29, 2025recall560d agoBrands International Corporation recall (Cls II)

Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3 — Reason: CGMP Deviations: lack of adequate release testing. — Status: Ongoing

full page →fda recalls ↗

›Jan 29, 2025recall560d agoFirst Aid Beauty Ltd recall (Cls II)

First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6 — Reason: CGMP Deviations; product intended for quarantine was inadvertently distributed — Status: Ongoing

full page →fda recalls ↗

›Jan 29, 2025recall560d agoSHOPPERS- PLAZA recall (Cls I)Eton Pharmaceuticals, Inc.

FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7 — Reason: Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide — Status: Ongoing

full page →fda recalls ↗

›Jan 29, 2025recall560d agoAppco Pharma LLC recall (Cls III)Appco Pharma LLC

Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90. — Reason: Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet — Status: Completed

full page →fda recalls ↗

›Jan 30, 2025approval559d agoBKEMV (ECULIZUMAB-AEEB) — FDA approvaleculizumab biosimilar

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

full page →eculizumab biosimilar →fda approvals ↗

›Jan 30, 2025approval559d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

›Jan 30, 2025approval559d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

›Jan 30, 2025approval559d agoJOURNAVX (SUZETRIGINE) — FDA approvalsuzetrigine

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

full page →suzetrigine →fda approvals ↗

›Jan 30, 2025approval559d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: SOMERSET THERAPS LLC. Form: INJECTABLE. Route: INJECTION

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Jan 31, 2025approval558d agoSOGROYA (SOMAPACITAN-BECO) — FDA approvalsomatriptan albumin bound LA

Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS

full page →somatriptan albumin bound LA →fda approvals ↗

›Jan 31, 2025approval558d agoPAXLOVID (COPACKAGED) (NIRMATRELVIR) — FDA approvalPAXLOVID (COPACKAGED)

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →PAXLOVID (COPACKAGED) →fda approvals ↗

›Jan 31, 2025approval558d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: MACLEODS PHARMS LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

›Jan 31, 2025approval558d agoUNASYN (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

›Jan 31, 2025approval558d agoPEPCID COMPLETE (CALCIUM CARBONATE) — FDA approvalKenvue Inc.

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

full page →fda approvals ↗

554d ago

GABAPENTIN — FDA approvalGABAPENTIN

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

full page →GABAPENTIN →fda approvals ↗

›Feb 4, 2025approval554d agoGABAPENTIN — FDA approvalGABAPENTIN

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

full page →GABAPENTIN →fda approvals ↗

›Feb 5, 2025approval553d agoBOSENTAN — FDA approvalBOSENTAN

Sponsor: NATCO PHARMA LTD. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →BOSENTAN →fda approvals ↗

›Feb 5, 2025approval553d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

full page →RIFATER →fda approvals ↗

›Feb 5, 2025approval553d agoWELLBUTRIN (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Feb 5, 2025recall553d agoThe W.S. Badger Company, Inc. recall (Cls III)

BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route 10, Gilsum NH, 03448 UPC 6 34084 47150 2 — Reason: Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use. — Status: Terminated

full page →fda recalls ↗

›Feb 5, 2025recall553d agoThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recall (Cls II)

Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA. — Reason: CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit — Status: Terminated

full page →fda recalls ↗

›Feb 5, 2025recall553d agoAstellas Pharma US Inc. recall (Cls I)Astellas Pharma US Inc

Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73. — Reason: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules — Status: Ongoing

full page →fda recalls ↗

›Feb 5, 2025recall553d agoMcKesson recall (Cls II)MCKESSON CORP

Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01 — Reason: cGMP Deviations: Product intended for quarantine was inadvertently distributed. — Status: Ongoing

full page →fda recalls ↗

›Feb 5, 2025recall553d agoAstellas Pharma US Inc. recall (Cls I)Astellas Pharma US Inc

Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73. — Reason: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules — Status: Ongoing

full page →fda recalls ↗

›Feb 6, 2025approval552d agoFLUOROURACIL — FDA approvalExtrovis AG

Sponsor: KINDOS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Feb 7, 2025approval551d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

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

full page →ZEPBOUND →fda approvals ↗

›Feb 7, 2025approval551d agoONGENTYS (OPICAPONE) — FDA approvalopicapone

Sponsor: AMNEAL. Form: CAPSULE. Route: ORAL

full page →opicapone →fda approvals ↗

547d ago

CAMCEVI KIT (LEUPROLIDE MESYLATE) — FDA approvalForesee Pharmaceuticals Co Ltd