2022 Adverse Reactions Labelling 
Digital Pharmacist
OCTOBER 24, 2022
Date of Approval: 9/30/2022. Common adverse effects include musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, and abdominal pain , among others. . Date of Approval: 9/29/2022. Common adverse effects noted include diarrhea, abdominal pain, nausea, and upper respiratory tract infection. .
European Pharmaceutical Review
DECEMBER 23, 2022
The second group received open-label Sunlenca. The most common adverse reactions with Sunlenca were injection site reactions (swelling, pain or redness) and nausea. As part of the trial, patients were enrolled into one of two study groups. After 52 weeks, 83 percent of participants continued to have HIV RNA suppression.
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European Pharmaceutical Review
SEPTEMBER 2, 2022
This can be achieved by reducing the burden of adverse reactions or by optimising benefits through patient selection (eg, contraindications, recommendations of use, warnings, concomitant medicine[s], or certain test parameters) and treatment management (eg, specific dosing regimen, relevant testing, patient follow-up). References.
European Pharmaceutical Review
DECEMBER 16, 2022
The trial is an ongoing, multinational, open-label, single-arm study evaluating the safety and efficacy of etranacogene dezaparvovec. No serious adverse reactions (SARs) were reported. Summer 2022 haemophilia trial update. The gene therapy was recently approved by the US Food and Drug Administration (FDA).
Pharmaceutical Technology
AUGUST 25, 2022
The latest approval is mainly based on positive findings from the single-arm, open-label, multicentre Phase I/II iMAGINE clinical trial of Imbruvica to treat moderate or severe cGVHD in paediatric and young adults aged one year to under 22 years. Additionally, the median duration of response was found to be 5.3
RX Note
JUNE 9, 2023
FDA Pregnancy and Lactation Labelling Final Rule, 2015 In the past, FDA Pregnancy Categories was used in US. To address this, on 13 December 2014, the FDA published the Pregnancy and Lactation Labelling Rule” (PLLR). Labelling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.
LifeProNow
APRIL 19, 2023
In Japan, Abecma was approved for manufacturing and marketing on January 20, 2022, and indicated for patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. and Europe.”
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