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calendar

28,923 catalysts · 9,438 approval · 5,000 device 510k · 4,728 grant · 2,966 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

from 2017-11-21×clear all

type

approval9,438
device 510k5,000
grant4,728
8k filing2,966
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

earnings479

phase 2 completion172

therapy area

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

Week of Jun 15, 2020

›Jun 19, 2020approval2241d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

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

full page →tedizolid phosphate →fda approvals ↗

›Jun 19, 2020approval2241d agoGIMOTI (METOCLOPRAMIDE HYDROCHLORIDE) — FDA approvalEvoke Pharma Inc

Sponsor: QOL MEDCL. Form: SPRAY, METERED. Route: NASAL

full page →fda approvals ↗

›Jun 19, 2020approval2241d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

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

full page →IBANDRONATE SODIUM →fda approvals ↗

Week of Jun 22, 2020

›Jun 22, 2020approval2238d agoXPOVIO (SELINEXOR) — FDA approvalselinexor

Sponsor: KARYOPHARM THERAPS. Form: TABLET. Route: ORAL

full page →selinexor →fda approvals ↗

›Jun 23, 2020approval

Week of Jun 29, 2020

›Jun 29, 2020approval2231d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Jun 29, 2020approval

Week of Jul 6, 2020

›Jul 10, 2020approval2220d agoERLEADA (APALUTAMIDE) — FDA approvalapalutamide

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

full page →apalutamide →fda approvals ↗

›Jul 10, 2020approval

Week of Jul 13, 2020

›Jul 13, 2020approval2217d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

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

full page →guselkumab →fda approvals ↗

›Jul 14, 2020approval

Week of Jul 20, 2020

›Jul 21, 2020approval2209d agoSTIVARGA (REGORAFENIB) — FDA approvalBayer AG

Sponsor: BAYER HLTHCARE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jul 21, 2020approval

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page 40 of 579

2237d ago

MEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗

›Jun 23, 2020approval2237d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗

›Jun 23, 2020approval2237d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: PH HEALTH. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Jun 23, 2020approval2237d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: PH HEALTH. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Jun 23, 2020approval2237d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: AM REGENT. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Jun 23, 2020approval2237d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: AM REGENT. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Jun 24, 2020approval2236d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Jun 24, 2020approval2236d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Jun 25, 2020approval2235d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗

›Jun 25, 2020approval2235d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗

›Jun 25, 2020approval2235d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗

›Jun 25, 2020approval2235d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗

›Jun 25, 2020approval2235d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗

›Jun 25, 2020approval2235d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗

›Jun 25, 2020approval2235d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗

›Jun 25, 2020approval2235d agoLIBTAYO (CEMIPLIMAB-RWLC) — FDA approvalcemiplimab

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INTRAVENOUS

full page →cemiplimab →fda approvals ↗

›Jun 25, 2020approval2235d agoFINTEPLA (FENFLURAMINE HYDROCHLORIDE) — FDA approvalfenfluramine hydrochloride

Sponsor: UCB INC. Form: SOLUTION. Route: ORAL

full page →fenfluramine hydrochloride →fda approvals ↗

›Jun 26, 2020approval2234d agoGAMIFANT (EMAPALUMAB-LZSG) — FDA approvalSobi Inc

Sponsor: NOVIMMUNE S.A.. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

2231d ago

FINGOLIMOD HYDROCHLORIDE — FDA approvalEzra Ventures LLC

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

full page →fda approvals ↗

›Jul 1, 2020approval2229d agoATORVASTATIN CALCIUM — FDA approvalSciegen Pharmaceuticals Inc

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

full page →fda approvals ↗

›Jul 1, 2020approval2229d agoLEVORPHANOL TARTRATE — FDA approvalLEVORPHANOL TARTRATE

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

full page →LEVORPHANOL TARTRATE →fda approvals ↗

2220d ago

ICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jul 10, 2020approval2220d agoRINVOQ (UPADACITINIB) — FDA approvalupadacitinib tartrate ER

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

full page →upadacitinib tartrate ER →fda approvals ↗

2216d ago

JULUCA (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jul 14, 2020approval2216d agoAMPHETAMINE SULFATE — FDA approvalAurolife Pharma LLC

Sponsor: DR REDDYS LABS SA. Form: TABLET. Route: ORAL

full page →fda approvals ↗