Viking Therapeutics announced Tuesday that its GLP-1/GIP receptor dual agonist helped patients lose up to nearly 15% of their weight over about three months in a Phase II study.
The U.S. drug regulator is set to increase the number of inspections at Indian drug manufacturing units in 2024 amid growing concerns over the quality of drugs, according to reports.
Despite a patent extension, Merck’s muscle relaxant reversal injection is now facing potential generic competition from Hikma Pharmaceuticals, which is seeking the FDA’s approval for a copycat version.
The U.S. Department of Justice has slapped BioMarin Pharmaceutical with a subpoena in connection with its sponsored testing programs for the rare disease therapies Vivizim and Naglazyme.
The FDA on Friday approved Alvotech and Teva’s Simlandi (adalimumab-ryvk), a biosimilar to AbbVie’s blockbuster antibody therapy Humira (adalimumab), ending a long and difficult regulatory road for the partners.
The European Medicines Agency has recommended expanding Johnson & Johnson and Legend Biotech’s CAR-T therapy Carvytki (ciltacabtagene autoleucel) for use as an earlier treatment in patients with relapsed or refractory multiple myeloma, Legend announced on Friday.
Roche on Sunday released results from the first stage of the Phase III OUtMATCH study, demonstrating that its asthma drug Xolair (omalizumab) can significantly reduce severe allergic reactions in patients with several food allergies.
A court in Uzbekistan sentenced 23 people to prison terms on Monday over the deaths of 68 children linked to contaminated cough syrups produced by India’s Marion Biotech, following a six-month-long trial.
Vifor Pharma and partner Travere Therapeutics on Friday won an endorsement for approval from the European Union’s drug regulator for their drug Filspari, part of an industry race to treat a rare, serious kidney condition known as IgAN.
The attorney general for one of the most populous U.S. states this week urged federal drug regulators to address safety risks associated with the widely used asthma and allergy medicine Singulair, saying current warnings on the drug’s packaging are insufficient, particularly for children.
