article thumbnail

FDA grants full approval for Roche/AbbVie’s Venclexta in AML combination therapies

pharmaphorum

The combination therapies had previously been marketed following accelerated approval in November 2018 on the basis of early stage results. Combination therapies involving Roche and AbbVie’s cancer drug Venclexta have been formally approved by the FDA in acute myeloid leukaemia, following supportive data from late-stage studies.

article thumbnail

Teething

RX Note

Viscous lidocaine has been associated with serious adverse reactions ( including death ) in young children being treated for mouth pain, including teething. Says, 2016 FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit, 2018

Insiders

Sign Up for our Newsletter

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

Trending Sources

article thumbnail

Anaemia in Chronic Kidney Disease

RX Note

External Links KDIGO CPG for Anemia in Chronic Kidney Disease, 2012 KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease, 2006 KDOQI US Commentary on the 2012 KDIGO Clinical Practice Guideline for Anemia in CKD, 2013 Recombinant human erythropoietins: very rare risk of severe cutaneous adverse (..)

article thumbnail

Drug Recall

RX Note

Classification Drug recalls can be classified to: 3 degrees based on the severity of quality defects and adverse reactions of the products Degree I: Products with major health risks that might cause serious injuries or death. Should be under an embargo within 24 hours. Degree II: Products with minor health risks or are substandard.

article thumbnail

Hypertension

RX Note

Resistant Hypertension Resistant hypertension is defined by a patient whose BP is not controlled on three or more drugs (including a diuretic). After excluding medication non-adherence and isolated office hypertension, a quick check on the possible causes of resistant is required.

article thumbnail

The 7 Most Common Nutrient Deficiencies in Hashimoto’s

The Thyroid Pharmacist

Most people with Hashimoto’s have deficiencies in these nutrients, and I’ve seen very limited adverse reactions with supplementation (please check the special considerations/cautions sections under each supplement heading to learn about adverse reactions). (12-16). Published 2018 Mar 20. Published 2018 Jul 2.

article thumbnail

FDA Releases Draft Labeling Guidance for Biosimilar Products

Big Molecule Watch

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.”