Remove Adverse Reactions Remove Events Remove Labelling
article thumbnail

Therapeutic-first for cold agglutinin disease haemolytic anaemia

European Pharmaceutical Review

The approval is based on data from two Phase III clinical trials: CADENZA, a trial for adults with CAD without having had a blood transfusion in the past six months and CARDINAL, a 26-week open label, single-arm pivotal study in patients with CAD who have had a recent blood transfusion. CADENZA Part A trial. Headache (22.7 percent vs 10.0

article thumbnail

FDA Accepts Pfizer’s sNDA for BRAFTOVI + MEKTOVI

LifeProNow

These sNDAs are supported by results from the PHAROS trial ( NCT03915951 ), an open-label, multicenter, non-randomized, Phase 2 study (n=98) to determine the safety, tolerability, and efficacy of BRAFTOVI given in combination with MEKTOVI in patients with BRAF V600E-mutant metastatic NSCLC. of patients. of patients.

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

Sanofi’s Sarclisa gains new US multiple myeloma indication

pharmaphorum

This label extension covers use of Sarclisa plus carfilzomib and dexamethasone for adults with relapsed or refractory multiple myeloma, who have received one to three previous therapy lines. In the trial, 8% of patients dropped out because of adverse events and 2.8% quit because of an infection.

article thumbnail

CHMP adopts positive opinion for haemophilia B gene therapy

European Pharmaceutical Review

In a clinical setting, etranacogene dezaparvovec continued to be generally well-tolerated with no serious treatment-related adverse events (SAEs). The trial is an ongoing, multinational, open-label, single-arm study evaluating the safety and efficacy of etranacogene dezaparvovec. HOPE-B trial for etranacogene dezaparvovec.

article thumbnail

How authentication of drugs has become a fundamental pillar of patient safety

Express Pharma

This widespread issue has led to treatment failures, adverse reactions, and even loss of life among patients. Pharmacovigilance and adverse event reporting: Traceability systems enable effective pharmacovigilance, which involves monitoring and reporting adverse drug reactions (ADRs) and safety concerns.

article thumbnail

BMS Submits Application for Abecma® for Relapsed or Refractory Multiple Myeloma

LifeProNow

Monitor for neurologic events after treatment with ABECMA. Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) including fatal and life-threatening reactions, occurred in patients following treatment with ABECMA. and Europe.” Provide supportive care and/or corticosteroids as needed.

article thumbnail

FDA Approvals: September 2022 Recap

Digital Pharmacist

Common adverse reactions include conjunctival/ocular hyperemia, photophobia, blurred vision, dry eye, pain, headache, irritation, and visual impairment. . Common adverse effects include serious or fatal respiratory failure, ischemic events, abdominal pain, nausea, and diarrhea, among others. .