pharmadog

News

when

Latest
Archive

by source

All Sources
Sources Page

Jobs

department

Clinical
Regulatory
Medical Affairs
Commercial
R&D / Discovery
Biostatistics / Data
Manufacturing / CMC
Market Access

therapeutic area

Oncology
Immunology
Neuroscience
Cardiovascular
Metabolic
Rare Disease
Infectious Disease

location & type

Remote Only
US Only
California
Massachusetts
Internships
Phase 3 Roles
All Jobs →

pharmadog

fetch the data · sniff the signal

Discover

Jobs
News

Hubs

Topics
Patent cliff
Publications

Tools

Compare
Search
Bookmarks

Trust

About
Sources
Contact

Legal

Privacy
Terms
Pricing

made by humans and a good dog

home
jobs
news
search

calendar

3,046 catalysts · 4,728 grant · 3,844 device 510k · 3,046 approval · 3,045 8k filing · 2,000 device pma · 2,000 device recall

★ save view ↓export CSV

next 91 dayslessmore

MonWedFri

view

agenda month

sort

soonest latest type sponsor alpha

type: approval×from 2025-02-04×clear all

type

grant4,728
device 510k3,844
approval3,046
8k filing3,045
device pma2,000
device recall2,000

device adverse event

1,000

recall931

earnings579

phase 2 completion172

therapy area

no tagged catalysts yet

Week of Feb 3, 2025

›Feb 4, 2025approval553d agoGABAPENTIN — FDA approvalGABAPENTIN

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

full page →GABAPENTIN →fda approvals ↗

›Feb 4, 2025approval553d agoGABAPENTIN — FDA approvalGABAPENTIN

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

full page →GABAPENTIN →fda approvals ↗

›Feb 5, 2025approval552d agoBOSENTAN — FDA approvalBOSENTAN

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

full page →BOSENTAN →fda approvals ↗

›Feb 5, 2025approval552d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

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

full page →RIFATER →fda approvals ↗

›Feb 5, 2025approval552d agoWELLBUTRIN (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Feb 6, 2025approval551d agoFLUOROURACIL — FDA approvalExtrovis AG

Sponsor: KINDOS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Feb 7, 2025approval550d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

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

full page →ZEPBOUND →fda approvals ↗

›Feb 7, 2025approval550d agoONGENTYS (OPICAPONE) — FDA approvalopicapone

Sponsor: AMNEAL. Form: CAPSULE. Route: ORAL

full page →opicapone →fda approvals ↗

Week of Feb 10, 2025

›Feb 10, 2025approval547d agoENZEEVU (AFLIBERCEPT-ABZV) — FDA approvalaflibercept biosimilar

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

full page →aflibercept biosimilar →fda approvals ↗

›Feb 11, 2025approval

Week of Feb 17, 2025

›Feb 18, 2025approval539d agoATROPINE SULFATE — FDA approvalATROPINE SULFATE

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

full page →ATROPINE SULFATE →fda approvals ↗

›Feb 18, 2025approval

← prev

page 1 of 61

546d ago

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

Sponsor: ACCORD. Form: EMULSION. Route: SUBCUTANEOUS

full page →fda approvals ↗

›Feb 11, 2025approval546d agoEVRYSDI (RISDIPLAM) — FDA approvalEVRYSDI

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

full page →EVRYSDI →fda approvals ↗

›Feb 11, 2025approval546d agoEVRYSDI (RISDIPLAM) — FDA approvalEVRYSDI

Sponsor: GENENTECH INC. Form: FOR SOLUTION. Route: ORAL

full page →EVRYSDI →fda approvals ↗

›Feb 11, 2025approval546d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

›Feb 11, 2025approval546d agoPEPCID COMPLETE (CALCIUM CARBONATE) — FDA approvalKenvue Inc.

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

full page →fda approvals ↗

›Feb 12, 2025approval545d agoMETHYLPREDNISOLONE ACETATE — FDA approvalMETHYLPREDNISOLONE ACETATE

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →METHYLPREDNISOLONE ACETATE →fda approvals ↗

›Feb 12, 2025approval545d agoMETHYLPREDNISOLONE ACETATE — FDA approvalMETHYLPREDNISOLONE ACETATE

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →METHYLPREDNISOLONE ACETATE →fda approvals ↗

›Feb 12, 2025approval545d agoIZERVAY (AVACINCAPTAD PEGOL SODIUM) — FDA approvalavacincaptad pegol sodium

Sponsor: ASTELLAS. Form: SOLUTION. Route: INTRAVITREAL

full page →avacincaptad pegol sodium →fda approvals ↗

›Feb 12, 2025approval545d agoPAXLOVID (COPACKAGED) (NIRMATRELVIR) — FDA approvalPAXLOVID (COPACKAGED)

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →PAXLOVID (COPACKAGED) →fda approvals ↗

›Feb 12, 2025approval545d agoSELARSDI (USTEKINUMAB-AEKN) — FDA approvalAlvotech

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

full page →fda approvals ↗

›Feb 12, 2025approval545d agoVICTOZA (LIRAGLUTIDE) — FDA approvalSaxenda

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

full page →Saxenda →fda approvals ↗

›Feb 12, 2025approval545d agoACETYLCYSTEINE — FDA approvalACETYLCYSTEINE

Sponsor: SOMERSET THERAPS LLC. Form: SOLUTION. Route: INHALATION, ORAL

full page →ACETYLCYSTEINE →fda approvals ↗

›Feb 13, 2025approval544d agoTRUQAP (CAPIVASERTIB) — FDA approvalcapivasertib

Sponsor: ASTRAZENECA. Form: TABLET. Route: ORAL

full page →capivasertib →fda approvals ↗

›Feb 13, 2025approval544d agoDENOSUMAB-DSSB — FDA approvaldenosumab biosimilar

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →denosumab biosimilar →fda approvals ↗

›Feb 14, 2025approval543d agoROMVIMZA (VIMSELTINIB) — FDA approvalDeciphera Pharmaceuticals Inc

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

full page →fda approvals ↗

›Feb 14, 2025approval543d agoRYBREVANT (AMIVANTAMAB-VMJW) — FDA approvalamivantamab

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

full page →amivantamab →fda approvals ↗

›Feb 14, 2025approval543d agoSIMLANDI (ADALIMUMAB-RYVK) — FDA approvalAlvotech

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

full page →fda approvals ↗

539d ago

LORBRENA (LORLATINIB) — FDA approvallorlatinib

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →lorlatinib →fda approvals ↗

›Feb 19, 2025approval538d agoOTULFI (USTEKINUMAB-AAUZ) — FDA approvalOTULFI

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

full page →OTULFI →fda approvals ↗

›Feb 19, 2025approval538d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

›Feb 19, 2025approval538d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

›Feb 21, 2025approval536d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →fda approvals ↗

›Feb 21, 2025approval536d agoBOSENTAN — FDA approvalBOSENTAN

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

full page →BOSENTAN →fda approvals ↗

›Feb 21, 2025approval536d agoBOSENTAN — FDA approvalZydus Therapeutics Inc

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

full page →fda approvals ↗

›Feb 21, 2025approval536d agoBOSENTAN — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

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

full page →fda approvals ↗

›Feb 21, 2025approval536d agoCARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER (NICARDIPINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: CHIESI. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

›Feb 21, 2025approval536d agoXELJANZ XR (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

Sponsor: PFIZER. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tofacitinib citrate ER →fda approvals ↗

›Feb 21, 2025approval536d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Feb 21, 2025approval536d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

Sponsor: PFIZER. Form: SOLUTION. Route: ORAL

full page →tofacitinib citrate ER →fda approvals ↗

›Feb 21, 2025approval536d agoBOSENTAN — FDA approvalBOSENTAN

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

full page →BOSENTAN →fda approvals ↗

›Feb 21, 2025approval536d agoBOSENTAN — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

›Feb 21, 2025approval536d agoBOSENTAN — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

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

full page →fda approvals ↗

›Feb 21, 2025approval536d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: ACTELION. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Feb 21, 2025approval536d agoBOSENTAN — FDA approvalBOSENTAN

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

full page →BOSENTAN →fda approvals ↗

›Feb 21, 2025approval536d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: ACTELION. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

›Feb 21, 2025approval536d agoSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Feb 21, 2025approval536d agoSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Feb 21, 2025approval536d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: RUBICON RESEARCH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Feb 21, 2025approval536d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Feb 21, 2025approval536d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

$NSRX2.7000-1.82%

$LLY1231.94+3.90%

$NVO47.73+0.99%

$AZN161.91+0.30%

$ALVO3.7700-1.05%

$PFE27.05+1.08%

$AMRX17.88-1.43%

$IGC0.2670+0.41%

$PFE27.05+1.08%

$NSRX2.7000-1.82%

$AMRX17.88-1.43%

$NSRX2.7000-1.82%

$IGC0.2670+0.41%

$AMRX17.88-1.43%

$IGC0.2670+0.41%

$ALVO3.7700-1.05%

$KVUE19.03-1.04%

$PFE27.05+1.08%