Calendar

Week of Sep 22, 2025

Sep 22, 2025grant332d agoJOHNS HOPKINS UNIVERSITY — Galvanic vestibular stimulation: from cellular mechanisms to behavioral respo...Johns Hopkins University

DC grant. $226,958. PI: Gene Yevgeny Fridman

full page →nih reporter ↗

Sep 22, 2025grant332d agoMERLIN BIOTECH INC — SBIR FY25 Concept Award, Development of an Immunotherapy for Ewing Sarcoma Us...MERLIN Biotech LLC

CA grant. $355,000

full page →nih reporter ↗

Sep 22, 2025grant332d agoUnknown institution — SUBJECT MATTER EXPERT FOR PROCESS CHEMISTRY DEVELOPMENT

DA grant. $8,460

full page →nih reporter ↗

Sep 23, 2025approval331d agoCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

Sep 23, 2025approval331d agoQUILLICHEW ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

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

full page →fda approvals ↗

Sep 23, 2025approval331d agoQUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

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

full page →fda approvals ↗

Sep 23, 2025approval331d agoCAMCEVI KIT (LEUPROLIDE MESYLATE) — FDA approvalForesee Pharmaceuticals Co Ltd

Sponsor: ACCORD. Form: EMULSION. Route: SUBCUTANEOUS

full page →fda approvals ↗

Sep 23, 2025approval331d agoCAPRELSA (VANDETANIB) — FDA approvalvandetanib

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

full page →vandetanib →fda approvals ↗

Sep 23, 2025approval331d agoLUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Sep 23, 2025approval331d agoLUPRON (LEUPROLIDE ACETATE) — FDA approvalInvaGen Pharmaceuticals Inc

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

full page →fda approvals ↗

Sep 23, 2025approval331d agoFLAREX (FLUOROMETHOLONE ACETATE) — FDA approvalHARROW, INC.

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

full page →fda approvals ↗

Sep 23, 2025approval331d agoALVIMOPAN — FDA approvalALVIMOPAN

Sponsor: HIKMA. Form: CAPSULE. Route: ORAL

full page →ALVIMOPAN →fda approvals ↗

Sep 23, 2025approval331d agoJORNAY PM (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

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

full page →fda approvals ↗

Sep 23, 2025approval331d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

full page →certolizumab pegol →fda approvals ↗

Sep 23, 2025approval331d agoTRIPTODUR KIT (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

Sponsor: AZURITY. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →triptorelin pamoate ER →fda approvals ↗

Sep 23, 2025approval331d agoDEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) — FDA approvalMallinckrodt LLC

Sponsor: IMPAX LABS INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Sep 23, 2025approval331d agoFOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) — FDA approvaldexmethylphenidate hydrochloride ER

Sponsor: SANDOZ. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →dexmethylphenidate hydrochloride ER →fda approvals ↗

Sep 23, 2025approval331d agoFENSOLVI KIT (LEUPROLIDE ACETATE) — FDA approvalLEUPROLIDE ACETATE

Sponsor: TOLMAR. Form: POWDER. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗

Sep 23, 2025approval331d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →triptorelin pamoate ER →fda approvals ↗

Sep 23, 2025approval331d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalMETHYLPHENIDATE HYDROCHLORIDE

Sponsor: ABHAI LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →METHYLPHENIDATE HYDROCHLORIDE →fda approvals ↗

Sep 23, 2025approval331d agoLEUPROLIDE ACETATE — FDA approvalInvaGen Pharmaceuticals Inc

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

full page →fda approvals ↗

Sep 23, 2025approval331d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalMETHYLPHENIDATE HYDROCHLORIDE

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

full page →METHYLPHENIDATE HYDROCHLORIDE →fda approvals ↗

Sep 23, 2025approval331d agoRELEXXII (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: OSMOTICA PHARM US. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Sep 23, 2025approval331d agoALVIMOPAN — FDA approvalPar Pharmaceutical Inc

Sponsor: WATSON LABS TEVA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Sep 23, 2025approval331d agoZOLADEX (GOSERELIN ACETATE) — FDA approvalgoserelin LA

Sponsor: TERSERA. Form: IMPLANT. Route: IMPLANTATION

full page →goserelin LA →fda approvals ↗

Sep 23, 2025approval331d agoPRIMIDONE — FDA approvalFrontida Biopharm Inc

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

full page →fda approvals ↗

Sep 23, 2025approval331d agoDAYTRANA (METHYLPHENIDATE) — FDA approvalNoven Pharmaceuticals Inc

Sponsor: NOVEN PHARMS INC. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fda approvals ↗

Sep 23, 2025approval331d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

Sponsor: AMNEAL. Form: SOLUTION. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗

Sep 23, 2025approval331d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

Sponsor: SANDOZ. Form: SOLUTION. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗

Sep 23, 2025approval331d agoLABETALOL HYDROCHLORIDE — FDA approvalLABETALOL HYDROCHLORIDE

Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL

full page →LABETALOL HYDROCHLORIDE →fda approvals ↗

Sep 23, 2025approval331d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

Sponsor: UBI. Form: SOLUTION. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗

Sep 23, 2025approval331d agoMETADATE CD (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETADATE CD

Sponsor: AYTU BIOPHARMA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →METADATE CD →fda approvals ↗

Sep 23, 2025approval331d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Sep 23, 2025approval331d agoXELSTRYM (DEXTROAMPHETAMINE) — FDA approvalNoven Pharmaceuticals Inc

Sponsor: NOVEN PHARMS INC. Form: SYSTEM. Route: TRANSDERMAL

full page →fda approvals ↗

Sep 23, 2025approval331d 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 ↗

Sep 23, 2025approval331d agoRITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalRITALIN LA

Sponsor: SANDOZ. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →RITALIN LA →fda approvals ↗

Sep 23, 2025approval331d agoTRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

full page →OXCARBAZEPINE →fda approvals ↗

Sep 23, 2025approval331d agoERYTHROMYCIN — FDA approvalAbon Pharmaceuticals LLC

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

full page →fda approvals ↗

Sep 23, 2025approval331d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →triptorelin pamoate ER →fda approvals ↗

Sep 23, 2025approval331d agoLEUPROLIDE ACETATE — FDA approvalInvaGen Pharmaceuticals Inc

Sponsor: EUGIA PHARMA. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

Sep 23, 2025approval331d agoADDERALL XR 10 (AMPHETAMINE ASPARTATE) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Sep 23, 2025approval331d agoRIVASTIGMINE — FDA approvalrivastigmine ER

Sponsor: YICHANG HUMANWELL. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →rivastigmine ER →fda approvals ↗

Sep 23, 2025approval331d agoAZSTARYS (DEXMETHYLPHENIDATE HYDROCHLORIDE) — FDA approvalSandoz Inc

Sponsor: COMMAVE THERAP. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Sep 23, 2025approval331d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: ALKEM LABS LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Sep 23, 2025approval331d agoAZITHROMYCIN — FDA approvalPFIZER INC

Sponsor: CHARTWELL RX. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

Sep 23, 2025approval331d agoZOLADEX (GOSERELIN ACETATE) — FDA approvalgoserelin LA

Sponsor: TERSERA. Form: IMPLANT. Route: IMPLANTATION

full page →goserelin LA →fda approvals ↗

Sep 23, 2025approval331d agoZOLADEX (GOSERELIN) — FDA approvalgoserelin LA

Sponsor: TERSERA. Form: IMPLANT. Route: IMPLANTATION

full page →goserelin LA →fda approvals ↗

Sep 23, 2025approval331d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →triptorelin pamoate ER →fda approvals ↗

Sep 23, 2025approval331d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalMETHYLPHENIDATE HYDROCHLORIDE

Sponsor: HERITAGE PHARMA. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →METHYLPHENIDATE HYDROCHLORIDE →fda approvals ↗

Sep 23, 2025approval331d agoBREVIBLOC (ESMOLOL HYDROCHLORIDE) — FDA approvalESMOLOL HYDROCHLORIDE

Sponsor: BAXTER HLTHCARE. Form: INJECTABLE. Route: INJECTION

full page →ESMOLOL HYDROCHLORIDE →fda approvals ↗

← prev

page 63 of 371

Week of Sep 22, 2025