PharmaShots

JUNE 23, 2023

Gilead Receives EMA’s CHMP Positive Opinion of Trodelvy (sacituzumab govitecan) for Pre-Treated HR+/HER2- Metastatic Breast Cancer Date: June 23, 2023 | Tags: Gilead, Trodelvy, sacituzumab govitecan, HR+/HER2- Metastatic Breast Cancer, Regulatory, EMA, CHMP, Positive Opinion Sarepta Therapeutics’ Elevidys Receives the US FDA’s Accelerated (..)

FDA 40

FDA 40

pharmaphorum

DECEMBER 23, 2022

There’s been huge progress in treatments for blood cancer in recent years – but drawbacks of expensive CAR-T cell and injected antibody therapies have led drug developers to look at novel oral therapies as patient-friendly alternatives. These are particularly important in the progression of certain blood cancers.

Immunization 52

Immunization Hospitals Vaccines 52

pharmaphorum

OCTOBER 29, 2021

Take two recently-approved immunotherapies for triple negative breast cancer (TNBC), put them together, and what do you get? Gilead is sponsoring the new study to see if adding Trodelvy can be an alternative chemo when added to Keytruda in the first-line treatment of advanced TNBC, in the hope of moving the ADC up the treatment pathway.

Chemotherapy 52

Chemotherapy FDA 52

pharmaphorum

MARCH 27, 2022

The CHMP recommended conditional approval for Carvykti (ciltacabtagene autoleucel or cilta-cel) as a treatment for adults with relapsed and refractory multiple myeloma who have received at least three prior therapies and whose cancer is worsening.

Labelling 91

Labelling Immunization FDA 91

The FDA Law Blog

JUNE 27, 2023

Amongst his accomplishments, Law360 considered the role James has played in leveraging little-used pathways to FDA approval for often first-ever drugs to treat rare diseases (e.g., In addition to Mr. Karst, ten other HP&M Directors were tagged as “Recommended” by WWL: Life Sciences 2023: Ricardo Carvajal Robert A. Dormer Jeffrey N.

FDA 81

FDA 81

The Checkup by Singlecare

MAY 8, 2023

It’s important to note that the CDC’s recommendations do not apply to pain related to sickle cell disease, cancer, or patients receiving palliative or end-of-life care. Belbuca is a good alternative to opioid treatment that needs to be taken around the clock, but it may come with a hefty price tag. fibromyalgia ).

Controlled Substances 52

Controlled Substances Dosage Labelling FDA 52