FDA, EMA grant Orphan Drug Designation to Carthera for carboplatin with SonoCloud technology in glioma

ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

The FDA Oncologic Drugs Advisory Committee July 25 voted unanimously to set more rigorous standards for new trials for approval of perioperative indications of cancer drugs.

July 26, 2024

Vol.50 No.30

By Jacquelyn Cobb and Paul Goldberg

Drugs & Targets

FDA accepts Telix’s NDA for prostate cancer imaging agent

FDA has accepted the filing of Telix Pharmaceuticals Limited’s New Drug Application for TLX007-CDx, a new and proprietary cold kit for the preparation of PSMA-PET imaging for prostate cancer.

July 26, 2024

Vol.50 No.30

Drugs & Targets

FDA clears IND for Zymeworks’ antibody drug conjugate ZW191

FDA cleared the investigational new drug application for ZW191, a novel folate receptor-α targeted topoisomerase I inhibitor antibody-drug conjugate sponsored by Zymeworks.

July 26, 2024

Vol.50 No.30

Drugs & Targets

EMA validates application for BMS’s Opdivo + Yervoy for unresectable or advanced HCC

The European Medicines Agency validated Bristol Myers Squibb’s Type II variation application for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a potential first-line treatment option for adult patients with unresectable or advanced hepatocellular carcinoma who have not received prior systemic therapy.

July 26, 2024

Vol.50 No.30

Drugs & Targets

EMA accepts MAA for GSK’s Blenrep combinations for R/R MM

The European Medicines Agency has accepted the marketing authorization application for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex) as a treatment for relapsed or refractory multiple myeloma.

July 26, 2024

Vol.50 No.30

Platinum drugs are off the shortage list, but the underlying problem is unsolved
FDA’s Califf: “We have a market failure due to unwillingness of health systems and cancer centers to pay a fair price.”

More than a year after a catastrophic shortage of platinum-based chemotherapy drugs swept through the U.S., FDA on June 28 officially removed carboplatin and cisplatin from the drug shortage list.

July 19, 2024

Vol.50 No.29

By Jacquelyn Cobb

FDA, EMA grant Orphan Drug Designation to Carthera for carboplatin with SonoCloud technology in glioma

YOU MAY BE INTERESTED IN

ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

FDA accepts Telix’s NDA for prostate cancer imaging agent

FDA clears IND for Zymeworks’ antibody drug conjugate ZW191

EMA validates application for BMS’s Opdivo + Yervoy for unresectable or advanced HCC

EMA accepts MAA for GSK’s Blenrep combinations for R/R MM

Platinum drugs are off the shortage list, but the underlying problem is unsolved
FDA’s Califf: “We have a market failure due to unwillingness of health systems and cancer centers to pay a fair price.”

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FDA, EMA grant Orphan Drug Designation to Carthera for carboplatin with SonoCloud technology in glioma

YOU MAY BE INTERESTED IN

ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

FDA accepts Telix’s NDA for prostate cancer imaging agent

FDA clears IND for Zymeworks’ antibody drug conjugate ZW191

EMA validates application for BMS’s Opdivo + Yervoy for unresectable or advanced HCC

EMA accepts MAA for GSK’s Blenrep combinations for R/R MM

Platinum drugs are off the shortage list, but the underlying problem is unsolvedFDA’s Califf: “We have a market failure due to unwillingness of health systems and cancer centers to pay a fair price.”

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Platinum drugs are off the shortage list, but the underlying problem is unsolved
FDA’s Califf: “We have a market failure due to unwillingness of health systems and cancer centers to pay a fair price.”