consilium.europa20d
Sustainable packaging: Council signs off on new rules for less waste and more re-use in the EU
The targets vary depending on the type of packaging used by operators (for instance, binding targets of 40% for transport and sales packaging and 10% for grouped packaging). According to the new rules ...
clinicaladvisor.com4d
FDA Approval Increases Eligibility for Cystic Fibrosis Medication Trikafta
Participants were randomly assigned to receive Trikafta or placebo based on age and weight: Aged 6 to < 12 years and less than 30 kg: morning dose of elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor ...
Business Wire16d
Vertex Announces U.S. FDA Approval for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Include Additional Non-F508del TRIKAFTA-Responsive Variants
BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of TRIKAFTA ® (elexacaftor ...
Pharmaceutical Technology13d
Vertex secures two FDA wins for cystic fibrosis, both with boxed warnings
Vertex has won two cystic fibrosis approvals from the FDA, but the agency included high-level safety warnings.
Yahoo Finance14d
Vertex Secures FDA Approval for New Cystic Fibrosis Drug Alyftrek
The drug is also eligible for use in CF patients who have discontinued Trikafta or Vertex’s other CF medicines. Similar regulatory filings are also under review in Europe. However, the drug’s ...
Nasdaq16d
Vertex announces FDA exands approval for Trikafta
Vertex Pharmaceuticals (VRTX) announced the U.S. Food and Drug Administration has approved the expanded use of Trikafta for the treatment of people with cystic fibrosis ages 2 and older who have ...
Investing16d
FDA expands approval for cystic fibrosis drug Trikafta
TRIKAFTA, a combination of elexacaftor, tezacaftor, and ivacaftor, is designed to enhance the function of the defective protein caused by cystic fibrosis transmembrane conductance regulator (CFTR ...
Investing16d
FDA expands approval for cystic fibrosis drug Trikafta
TRIKAFTA, a combination of elexacaftor, tezacaftor, and ivacaftor, is designed to enhance the function of the defective protein caused by cystic fibrosis transmembrane conductance regulator (CFTR) ...
Independent Online26d
Access to life-saving cystic fibrosis medication secured in South Africa
South Africans living with cystic fibrosis, a rare and life-threatening genetic condition, have welcomed improved access to essential medication following an agreement between the Competition ...
STAT24d
South African regulator decides Vertex provides sufficient access to CF drugs, angering activists
generic versions of Trikafta, a particularly effective triple-combination treatment for the disease, which causes the body to produce thick, sticky mucus that damages the lungs and other organs.
MedPage Today17d
Next-in-Class Once-Daily Pill Approved for Cystic Fibrosis
Share on Facebook. Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA approved a once-daily oral combination of ...