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calendar

26,353 catalysts · 6,708 approval · 5,000 device 510k · 4,728 grant · 3,126 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

from 2021-04-28×clear all

type

approval6,708
device 510k5,000
grant4,728
8k filing3,126
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

earnings583

phase 2 completion172

therapy area

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

Week of Nov 1, 2021

›Nov 4, 2021approval1742d agoDYANAVEL XR 20 (AMPHETAMINE) — FDA approvalDYANAVEL XR 20

Sponsor: TRIS PHARMA INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →DYANAVEL XR 20 →fda approvals ↗

›Nov 5, 2021approval1741d agoEPRONTIA (TOPIRAMATE) — FDA approvaltopiramate ER

Sponsor: AZURITY. Form: SOLUTION. Route: ORAL

full page →topiramate ER →fda approvals ↗

Week of Nov 8, 2021

›Nov 8, 2021approval1738d agoMYORISAN (ISOTRETINOIN) — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: UPSHER SMITH LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Nov 8, 2021approval

Week of Nov 15, 2021

›Nov 16, 2021approval1730d agoPALIPERIDONE — FDA approvalEskayef Pharmaceuticals Ltd

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

full page →fda approvals ↗

›Nov 17, 2021approval

Week of Nov 22, 2021

›Nov 22, 2021approval1724d agoULTOMIRIS (RAVULIZUMAB-CWVZ) — FDA approvalAlexion Pharmaceuticals Inc

Sponsor: ALEXION PHARM. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Nov 23, 2021approval

Week of Nov 29, 2021

›Nov 30, 2021approval1716d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

Sponsor: ABBVIE. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

›Nov 30, 2021approval

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page 8 of 528

1738d ago

CLARAVIS (ISOTRETINOIN) — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Nov 8, 2021approval1738d agoAMNESTEEM (ISOTRETINOIN) — FDA approvalMylan Pharmaceuticals Inc

Sponsor: MYLAN PHARMS INC. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Nov 8, 2021approval1738d agoCLARAVIS (ISOTRETINOIN) — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Nov 8, 2021approval1738d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

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

full page →fda approvals ↗

›Nov 9, 2021approval1737d agoZENATANE (ISOTRETINOIN) — FDA approvalISOTRETINOIN

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

full page →ISOTRETINOIN →fda approvals ↗

›Nov 9, 2021approval1737d agoTESTOSTERONE — FDA approvalTransdermal Delivery Solutions Corp

Sponsor: ENCUBE. Form: GEL. Route: TRANSDERMAL

full page →fda approvals ↗

›Nov 10, 2021approval1736d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Nov 10, 2021approval1736d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Nov 10, 2021approval1736d agoGAVRETO (PRALSETINIB) — FDA approvalRIGEL PHARMACEUTICALS INC

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

full page →fda approvals ↗

›Nov 12, 2021approval1734d agoDHIVY (CARBIDOPA) — FDA approvalAvion Pharmaceuticals LLC

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

full page →fda approvals ↗

›Nov 12, 2021approval1734d agoFULVESTRANT — FDA approvalFULVESTRANT

Sponsor: AVYXA HOLDINGS. Form: SOLUTION. Route: INTRAMUSCULAR

full page →FULVESTRANT →fda approvals ↗

›Nov 12, 2021approval1734d agoLUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

1729d ago

KEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Nov 17, 2021approval1729d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

Sponsor: CUBIST PHARMS LLC. Form: TABLET. Route: ORAL

full page →tedizolid phosphate →fda approvals ↗

›Nov 17, 2021approval1729d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

Sponsor: CUBIST PHARMS LLC. Form: POWDER. Route: INTRAVENOUS

full page →tedizolid phosphate →fda approvals ↗

›Nov 19, 2021approval1727d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

Sponsor: CUMBERLAND PHARMS. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

›Nov 19, 2021approval1727d agoOLANZAPINE — FDA approvalolanzapine ODT