Remove FDA Approval Remove Hormones Remove Research Remove Trials
article thumbnail

AstraZeneca and MSD’s Lynparza combo bags FDA approval for prostate cancer

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted a combination of AstraZeneca and MSD ’s Lynparza (olaparib), with standard therapies for treating BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Safety and tolerability were in line with that observed in prior trials and the known profiles of the medicines.

article thumbnail

Pfizer’s Ngenla Approved as Once-Weekly Treatment for Pediatric Growth Hormone Deficiency (GHD)

XTalks

Pfizer has been going strong on the approval front, having secured its fifth US Food and Drug Administration (FDA) approval in the past five weeks, with the most recent being for the company’s once-weekly human growth hormone analog Ngenla (somatrogon-ghla).

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Astellas’ nonhormonal hot flashes treatment Veozah wins FDA nod

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Astellas Pharma’s Veozah (fezolinetant) for use against moderate to severe vasomotor symptoms caused by menopause on May 12 after some delays due to an extended review. However, the use of hormone replacement therapy comes with its set of challenges.

Hormones 244
article thumbnail

FDA Approves First Oral Hormone Therapy for Advanced Prostate Cancer

The Pharma Data

FDA Approves First Oral Hormone Therapy for Advanced Prostate Cancer. 21, 2020 — Orgovyx (relugolix) is now approved to treat advanced prostate cancer and is the first oral hormone therapy approved for this indication, the U.S. Professional. MONDAY, Dec. Food and Drug Administration announced Friday.

article thumbnail

Jesduvroq (daprodustat) is FDA Approved for Anemia due to Chronic Kidney Disease

XTalks

GlaxoSmithKline LLC (GSK) recently announced that the US Food and Drug Administration (FDA) approved Jesduvroq (daprodustat), a new once-a-day oral treatment for anemia due to chronic kidney disease (CKD). The approval is currently only for adult patients who have been undergoing dialysis for at least four months.

article thumbnail

FDA Approves

The Pharma Data

Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

article thumbnail

Lilly’s new drug Mounjaro (tirzepatide ) wins US FDA approval

pharmaphorum

GLP-1 and GIP are hormones involved in blood sugar control and Mounjaro, a first-in-class medicine that activates both GLP-1 and GIP receptors, demonstrated improved blood sugar control. And, in trials comparing Mounjaro to other diabetes medications, individuals who received 15mg of Mounjaro had lowering of their HbA1c by 0.5%