pharmaphorum

JANUARY 5, 2021

The FDA’s breakthrough status is for tiragolumab plus Tecentriq is the first for a TIGIT drug, and covers the first-line treatment of patients with advanced-stage non-small cell lung cancer (NSCLC) that expresses high levels of PD-L1. The post Roche nabs breakthrough tag for TIGIT cancer immunotherapy appeared first on.

Chemotherapy 52

Chemotherapy Immunization FDA Labelling 52

PharmaShots

MARCH 31, 2023

PDS Biotech to Initiate P-III Trial (VERSATILE-003) of PDS0101 + Keytruda (pembrolizumab) for Head and Neck Cancer Date: Mar 31, 2023 | Tags: PDS Biotech, PDS0101, Keytruda, pembrolizumab, Head, Neck Cancer, Clinical Trial, P-III, VERSATILE-003 Trial Omega Therapeutics Entered into a Clinical Supply Agreement with Roche to Evaluate OTX-2002 for Hepatocellular (..)

FDA 40

FDA 40

PharmaShots

MAY 26, 2023

Takeda and HUTCHMED's Fruquintinib Receives Priority Review from the US FDA to Treat Metastatic Colorectal Cancer Date: May 26, 2023 | Tags: Takeda, HUTCHMED, Fruquintinib, Metastatic Colorectal Cancer, Regulatory, Priority Review, US, FDA Gilead Receives EMA’s CHMP Positive Opinion to Extend the Use of Veklury (remdesivir) for COVID-19 Date: (..)

FDA 40

FDA 40

pharmaphorum

JANUARY 5, 2022

The FDA thinks an antibody-drug conjugate (ADC) developed by AbbVie could set new standards in treatment for certain patients with lung cancer, awarding the drug breakthrough status. The post FDA gives AbbVie’s c-Met lung cancer ADC a breakthrough tag appeared first on. Preliminary results from that study showed a 53.8%

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FDA Chemotherapy 110

pharmaphorum

JANUARY 11, 2021

While bluebird has conducted pioneering work in gene therapy for blood disorders and in cancer cell therapy, products have been delayed by issues with filing data for the FDA. million price tag. Zynteglo is already in beta-thalassemia in Europe, where the company will seek to expand access despite its hefty $1.8

FDA 63

FDA 63

pharmaphorum

OCTOBER 29, 2021

Take two recently-approved immunotherapies for triple negative breast cancer (TNBC), put them together, and what do you get? “This helps further our ambition of displacing chemotherapy with Trodelvy to improve outcomes for people living with cancer,” said Gilead’s chief medical officer Merdad Parsey.

Chemotherapy 52

Chemotherapy FDA 52

European Pharmaceutical Review

DECEMBER 27, 2023

Being a cellular therapy that involves cell manipulation and molecular transfection – and above all, being a living drug – makes CAR T-cell therapy a somewhat challenging immunotherapy to manufacture in‑house. This is in addition to its considerable price tag. References Liu D. Journal of Hematology & Oncology. 2019;12(1).

Adverse Reactions 88

Adverse Reactions Immunization Medical Schools Chemotherapy 88