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calendar

18,993 catalysts · 18,987 approval · 7,208 phase readout · 5,000 device 510k · 4,728 grant · 3,603 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 readout7,208
device 510k5,000
grant4,728
8k filing3,603
device pma2,000
device recall

2,000

recall1,126

device adverse event1,000

earnings585

therapy area

Ophthalmology5

Week of Sep 8, 2025

›Sep 10, 2025approval353d agoKOSELUGO (SELUMETINIB) — FDA approvalselumetinib sulfate

Sponsor: ASTRAZENECA. Form: CAPSULE. Route: ORAL

full page →selumetinib sulfate →fda approvals ↗

›Sep 10, 2025approval353d agoOSENVELT (DENOSUMAB-BMWO) — FDA approvalOSENVELT

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

full page →OSENVELT →fda approvals ↗

›Sep 10, 2025approval353d agoCABOMETYX (CABOZANTINIB S-MALATE) — FDA approvalcabozantinib s-malate

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

full page →cabozantinib s-malate →fda approvals ↗

›Sep 11, 2025approval352d agoEPKINLY (EPCORITAMAB-BYSP) — FDA approvalepcoritamab

Sponsor: GENMAB US, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →epcoritamab →fda approvals ↗

›Sep 11, 2025approval352d agoILLUCCIX (GALLIUM GA-68 GOZETOTIDE) — FDA approvalILLUCCIX

Sponsor: TELIX. Form: POWDER. Route: INTRAVENOUS

full page →ILLUCCIX →fda approvals ↗

Week of Sep 15, 2025

›Sep 15, 2025approval348d agoFLONASE SENSIMIST ALLERGY RELIEF (FLUTICASONE FUROATE) — FDA approvalGlaxoSmithKline LLC

Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL

full page →fda approvals ↗

›Sep 16, 2025approval

Week of Sep 22, 2025

›Sep 22, 2025approval341d agoDOXYCYCLINE — FDA approvalPrasco LLC

Sponsor: DR REDDYS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Sep 22, 2025approval

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page 329 of 380

347d ago

ACETAZOLAMIDE — FDA approvalACETAZOLAMIDE

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

full page →ACETAZOLAMIDE →fda approvals ↗

›Sep 16, 2025approval347d agoACETAZOLAMIDE — FDA approvalACETAZOLAMIDE

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

full page →ACETAZOLAMIDE →fda approvals ↗

›Sep 16, 2025approval347d agoHYMPAVZI (MARSTACIMAB-HNCQ) — FDA approvalmarstacimab

Sponsor: PFIZER INC. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →marstacimab →fda approvals ↗

›Sep 16, 2025approval347d agoAUKELSO (DENOSUMAB-KYQQ) — FDA approvalAUKELSO

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

full page →AUKELSO →fda approvals ↗

›Sep 17, 2025approval346d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

›Sep 17, 2025approval346d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

›Sep 17, 2025approval346d agoBKEMV (ECULIZUMAB-AEEB) — FDA approvaleculizumab biosimilar

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

full page →eculizumab biosimilar →fda approvals ↗

›Sep 17, 2025approval346d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Sep 17, 2025approval346d agoAMJEVITA (ADALIMUMAB-ATTO) — FDA approvalAMJEVITA

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

full page →AMJEVITA →fda approvals ↗

›Sep 19, 2025approval344d agoKEYTRUDA QLEX (PEMBROLIZUMAB) — FDA approval(berahyaluronidase alfa + pembrolizumab)

Sponsor: MERCK SHARP DOHME. Form: INJECTABLE. Route: INJECTION

full page →(berahyaluronidase alfa + pembrolizumab) →fda approvals ↗

›Sep 19, 2025approval344d agoKEYTRUDA QLEX (PEMBROLIZUMAB) — FDA approval(berahyaluronidase alfa + pembrolizumab)

Sponsor: MERCK SHARP DOHME. Form: INJECTABLE. Route: INJECTION

full page →(berahyaluronidase alfa + pembrolizumab) →fda approvals ↗

›Sep 19, 2025approval344d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Sep 19, 2025approval344d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Sep 19, 2025approval344d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Sep 19, 2025approval344d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

›Sep 19, 2025approval344d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

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

full page →guselkumab →fda approvals ↗

›Sep 19, 2025approval344d agoLEUPROLIDE ACETATE — FDA approvalInvaGen Pharmaceuticals Inc

Sponsor: SUN PHARM. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

›Sep 19, 2025approval344d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

Sponsor: MEITHEAL. Form: SOLUTION. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗

›Sep 19, 2025approval344d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

Sponsor: MEITHEAL. Form: SOLUTION. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗

›Sep 19, 2025approval344d agoLOPERAMIDE HYDROCHLORIDE — FDA approvalLOPERAMIDE HYDROCHLORIDE

Sponsor: BIONPHARMA. Form: SOLUTION. Route: ORAL

full page →LOPERAMIDE HYDROCHLORIDE →fda approvals ↗

›Sep 19, 2025approval344d agoAMBRISENTAN — FDA approvalAMBRISENTAN

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →AMBRISENTAN →fda approvals ↗

›Sep 19, 2025approval344d agoFORZINITY (ELAMIPRETIDE HYDROCHLORIDE) — FDA approvalelamipretide hydrochloride

Sponsor: STEALTH BIOTHERAPS. Form: SOLUTION. Route: SUBCUTANEOUS

full page →elamipretide hydrochloride →fda approvals ↗

›Sep 19, 2025approval344d agoDIVALPROEX SODIUM — FDA approvalUnichem Pharmaceuticals (USA) Inc

Sponsor: SUN PHARM INDS. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →fda approvals ↗

›Sep 19, 2025approval344d agoDIVALPROEX SODIUM — FDA approvalUnichem Pharmaceuticals (USA) Inc

Sponsor: SUN PHARM INDS. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →fda approvals ↗

›Sep 19, 2025approval344d agoGABAPENTIN — FDA approvalGABAPENTIN

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

full page →GABAPENTIN →fda approvals ↗

›Sep 19, 2025approval344d agoPROGESTERONE — FDA approvalPROGESTERONE

Sponsor: XIROMED. Form: INSERT. Route: VAGINAL

full page →PROGESTERONE →fda approvals ↗

›Sep 19, 2025approval344d agoDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ATROPINE SULFATE) — FDA approvalANI PHARMACEUTICALS INC

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

full page →fda approvals ↗

›Sep 19, 2025approval344d agoGABAPENTIN — FDA approvalSciegen Pharmaceuticals Inc

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

full page →fda approvals ↗

›Sep 19, 2025approval344d agoLOSARTAN POTASSIUM — FDA approvalGraviti Pharmaceuticals Inc

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

full page →fda approvals ↗

›Sep 19, 2025approval344d agoPROPOFOL — FDA approvalPROPOFOL

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →PROPOFOL →fda approvals ↗

341d ago

IRON SUCROSE — FDA approvalsuccharated ferric oxide

Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS

full page →succharated ferric oxide →fda approvals ↗

›Sep 22, 2025approval341d agoBIMATOPROST — FDA approvalLumigan

Sponsor: AMNEAL. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →Lumigan →fda approvals ↗

›Sep 23, 2025approval340d agoCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Sep 23, 2025approval340d agoQUILLICHEW ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: NEXTWAVE PHARMS. Form: TABLET, EXTENDED RELEASE, CHEWABLE. Route: ORAL

full page →fda approvals ↗

›Sep 23, 2025approval340d agoQUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: NEXTWAVE. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Sep 23, 2025approval340d agoCAMCEVI KIT (LEUPROLIDE MESYLATE) — FDA approvalForesee Pharmaceuticals Co Ltd

Sponsor: ACCORD. Form: EMULSION. Route: SUBCUTANEOUS

full page →fda approvals ↗

›Sep 23, 2025approval340d agoCAPRELSA (VANDETANIB) — FDA approvalvandetanib

Sponsor: GENZYME CORP. Form: TABLET. Route: ORAL

full page →vandetanib →fda approvals ↗

›Sep 23, 2025approval340d agoLUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: ABBVIE ENDOCRINE INC. Form: POWDER. Route: INTRAMUSCULAR

full page →fda approvals ↗

›Sep 23, 2025approval340d agoLUPRON (LEUPROLIDE ACETATE) — FDA approvalInvaGen Pharmaceuticals Inc

Sponsor: ABBVIE ENDOCRINE INC. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

›Sep 23, 2025approval340d agoFLAREX (FLUOROMETHOLONE ACETATE) — FDA approvalHARROW, INC.

Sponsor: HARROW EYE. Form: SUSPENSION/DROPS. Route: OPHTHALMIC

full page →fda approvals ↗

›Sep 23, 2025approval340d agoALVIMOPAN — FDA approvalALVIMOPAN

Sponsor: HIKMA. Form: CAPSULE. Route: ORAL

full page →ALVIMOPAN →fda approvals ↗

›Sep 23, 2025approval340d agoJORNAY PM (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: IRONSHORE PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Sep 23, 2025approval340d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

full page →certolizumab pegol →fda approvals ↗

$AZN164.52-1.05%

$EXEL55.26-1.50%

$TLX

$HCWB

$AMGN439.48-0.20%

$PFE28.03-0.96%

$RDHL0.7390+6.64%

$AMRX17.54-2.61%

$AMGN439.48-0.20%

$ANIP73.85-0.95%

$COLL26.44-3.89%

$AMRX17.54-2.61%

$HROW37.27-3.30%

$COLL26.44-3.89%