Calendar

Week of Mar 23, 2026

Mar 24, 2026grant146d agoYALE UNIVERSITY — Leveraging Clinical Data and Automation to Predict Epilepsy After TBI

NS grant. $722,338. PI: Jennifer A Kim

Mar 24, 2026grant146d agoDANA-FARBER CANCER INST — TIRR/53BP1 complex regulates mitotic fidelity and immune-mediated radiation r...

CA grant. $683,075. PI: Dipanjan Chowdhury

full page →nih reporter ↗

Mar 25, 2026approval145d agoMARINOL (DRONABINOL) — FDA approvalVertanical GmbH

Sponsor: ALKEM LABS LTD. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Mar 25, 2026approval145d agoTRETINOIN — FDA approvalMylan Pharmaceuticals Inc

Sponsor: ENCUBE. Form: CREAM. Route: TOPICAL

full page →fda approvals ↗

Mar 25, 2026approval145d agoELREXFIO (ELRANATAMAB) — FDA approvalelranatamab

Sponsor: PFIZER INC. Form: SOLUTION. Route: INJECTION

full page →elranatamab →fda approvals ↗

Mar 25, 2026approval145d agoWINREVAIR (SOTATERCEPT-CSRK) — FDA approvalsotatercept

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

full page →sotatercept →fda approvals ↗

Mar 25, 2026approval145d agoLIFYORLI (COPACKAGED) (RELACORILANT) — FDA approvalCORCEPT THERAPEUTICS INC

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

full page →fda approvals ↗

Mar 25, 2026approval145d agoKRAZATI (ADAGRASIB) — FDA approvalBristol-Myers Squibb Co

Sponsor: BRISTOL. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 25, 2026approval145d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalMETHYLPHENIDATE HYDROCHLORIDE

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

full page →METHYLPHENIDATE HYDROCHLORIDE →fda approvals ↗

Mar 25, 2026recall145d agoApotex Corp. recall (Cls II)Apotex Corp

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Mar 25, 2026recall145d agoSTRIDES PHARMA INC recall (Cls II)Strides Pharma Inc

Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8. — Reason: Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. — Status: Ongoing

full page →fda recalls ↗

Mar 25, 2026recall145d agoAnnora Pharma Private Limited recall (Cls III)Annora Pharma Pvt Ltd

Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, India, NDC 72603-479-01. — Reason: Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg — Status: Ongoing

full page →fda recalls ↗

Mar 25, 2026recall145d agoCardinal Health 200, LLC recall (Not Yet Classified)CARDINAL HEALTH INC

Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085. — Reason: Microbial Contamination of Sterile Products: Affected lots have been deemed non-sterile following discovery of a contaminant (Paenibacillus phoenicis), which may pose a potential infection risk to vulnerable groups. — Status: Ongoing

full page →fda recalls ↗

Mar 25, 2026recall145d agoSOMERSET THERAPEUTICS LLC recall (Cls II)Somerset Therapeutics LLC

Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC carton: 70069-025-10; NDC vial: 70069-025-01 — Reason: Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate. — Status: Ongoing

full page →fda recalls ↗

Mar 25, 2026device 510k145d agoSpectrum Vascular — Arterial Pressure Monitoring Set/Tray (510k cleared)

Product code: DQO. Advisory committee: Cardiovascular. Type: Special

full page →fda device 510k ↗

Mar 25, 2026device 510k145d agoNvision Biomedical Technologies, Inc. — Vortex5 Tailor's Bunion Correction System (510k cleared)

Product code: HRS. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗

Mar 25, 2026device 510k145d agoArthroCare Corporation — LYNX COBLATION Laryngeal Wand (72290254) (510k cleared)

Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗

Mar 25, 2026device 510k145d agoLetus Corporation — MiraChlor Antimicrobial Wound Solution (510k cleared)

Product code: FRO. Advisory committee: Unknown. Type: Traditional

full page →fda device 510k ↗

Mar 25, 2026device 510k145d agoAlphatec Spine, Inc. — Invictus Bands System (510k cleared)

Product code: OWI. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗

Mar 25, 2026device 510k145d agoMedline Industries, LP — Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech with 78 Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60 Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44 Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) (510k cleared)

Product code: BZE. Advisory committee: Anesthesiology. Type: Traditional

full page →fda device 510k ↗

Mar 25, 2026device 510k145d agoNovastep SAS — Airlock® Ankle Plating System (510k cleared)

Product code: HRS. Advisory committee: Orthopedic. Type: Abbreviated

full page →fda device 510k ↗

Mar 25, 2026device 510k145d agoZhuhai Wesee Meditech Co., Ltd. — Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) (510k cleared)

Product code: EOB. Advisory committee: Ear, Nose, Throat. Type: Traditional

full page →fda device 510k ↗

Mar 25, 2026device 510k145d agoSandstone Medical (Suzhou), Inc. — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle (510k cleared)

Product code: FMI. Advisory committee: General Hospital. Type: Special

full page →fda device 510k ↗

Mar 25, 2026device 510k145d agoCurexo, Inc. — CUVIS-joint (CJ150) (510k cleared)Curevo Inc

Product code: OLO. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗

Mar 25, 2026device 510k145d agoSpinepoint, LLC — Flex-Z Cervical Cage (510k cleared)

Product code: ODP. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗

Mar 25, 2026device 510k145d agoMevion Medical Systems, Inc. — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (510k cleared)MERIT MEDICAL SYSTEMS INC

Product code: LHN. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗

Mar 25, 2026device 510k145d agoBausch and Lomb, Incorporated — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) (510k cleared)

Product code: HQC. Advisory committee: Ophthalmic. Type: Traditional

full page →fda device 510k ↗

Mar 25, 2026device pma145d agoLenstec, Inc. — ClearView 3 IOL (PMA supplement)

Supplement type: Real-Time Process. Product code: MFK. Advisory committee: OP. Decision: APPR

full page →fda device pma ↗

Mar 25, 2026device pma145d agoABBOTT MEDICAL — CardioMEMS HF System (PMA supplement)

Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Mar 25, 2026device pma145d agoBoston Scientific Corp — WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Normal 180 Day Track No User Fee. Product code: NGV. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Mar 25, 2026device pma145d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System (PMA supplement)

Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Mar 25, 2026device pma145d agoMedtronic Vascular — Onyx Frontier Zotarolimus Eluting Coronary Stent System (PMA supplement)

Supplement type: 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Mar 25, 2026device pma145d agoMedtronic, Inc. — Symplicity Spyral Renal Denervation Catheter (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: QYI. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Mar 25, 2026device pma145d agoCook Ireland, Ltd. — Zilver® PTX® Drug-Eluting Peripheral Stent (PMA supplement)

Supplement type: 30-Day Notice. Product code: NIU. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Mar 25, 2026grant145d agoMASSACHUSETTS GENERAL HOSPITAL — Characterizing intracortical feedforward and feedback sensory processes in ASDMassachusetts General Hospital

MH grant. $824,728. PI: Jyrki Ahveninen

full page →nih reporter ↗

Mar 25, 2026grant145d agoUNIVERSITY OF TEXAS HLTH SCIENCE CENTER — Development of first-in-class AAK1 PROTACs for ovarian cancer

CA grant. $593,338. PI: Lingtao Jin

full page →nih reporter ↗

Mar 25, 2026grant145d agoSTANFORD UNIVERSITY — Advancing Personalized Cardiac Organoids - Converging In Vitro, In Chemico, a...Stanford University

TR grant. $3,091,157. PI: Afshin Beheshti

full page →nih reporter ↗

Mar 25, 2026grant145d agoMASSACHUSETTS INSTITUTE OF TECHNOLOGY — A Platform for Arene Activation via Machine Learning and Small Molecule Catal...

GM grant. $74,632. PI: Andria Pace

full page →nih reporter ↗

Mar 25, 2026grant145d agoMEDICAL UNIVERSITY OF SOUTH CAROLINA — RESP-FIT: A Respiratory Muscle Strength Training Intervention for COPD

NR grant. $1,778,418. PI: Sarah N. Miller

full page →nih reporter ↗

Mar 25, 2026grant145d agoWASHINGTON UNIVERSITY — Neural Circuits in Preoptic Hypothalamus Regulating Energy Expenditure and Me...

DK grant. $720,353. PI: Aaron J Norris

full page →nih reporter ↗

Mar 25, 2026grant145d agoJOHNS HOPKINS UNIVERSITY — Adapting and testing an evidence based digitally delivered healthy relationsh...Johns Hopkins University

NR grant. $1,804,481. PI: Teresa Brockie

full page →nih reporter ↗

Mar 25, 2026grant145d agoICAHN SCHOOL OF MEDICINE AT MOUNT SINAI — Ghrelin receptor and striosomal interactions in stress-induced decision-makingDutch Heart Foundation

MH grant. $827,879. PI: Alexander Friedman

full page →nih reporter ↗

Mar 26, 2026approval144d agoCLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →CLEOCIN →fda approvals ↗

Mar 26, 2026approval144d agoBKEMV (ECULIZUMAB-AEEB) — FDA approvaleculizumab biosimilar

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

full page →eculizumab biosimilar →fda approvals ↗

Mar 26, 2026approval144d agoCLEOCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) — FDA approvalclindamycin hydrochloride

Sponsor: PFIZER. Form: CAPSULE. Route: ORAL

full page →clindamycin hydrochloride →fda approvals ↗

Mar 26, 2026approval144d agoNOREPINEPHRINE BITARTRATE IN 5% DEXTROSE (NOREPINEPHRINE BITARTRATE) — FDA approvalNOREPINEPHRINE BITARTRATE

Sponsor: SAGENT. Form: SOLUTION. Route: INTRAVENOUS

full page →NOREPINEPHRINE BITARTRATE →fda approvals ↗

Mar 26, 2026approval144d agoMEKINIST (TRAMETINIB) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

full page →Spexotras →fda approvals ↗

Mar 26, 2026approval144d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

Mar 26, 2026approval144d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗

Mar 26, 2026approval144d agoCLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →CLEOCIN →fda approvals ↗

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Week of Mar 23, 2026