Approvals
The European Medicines Agency is set to adopt opinions on whether marketing approval should be granted to five new products, including three orphans. A decision is also due on a previously-rejected Alzheimer’s drug that was under re-examination.
The agency is conducting further investigation of reports of altered skin sensation that occurred more frequently with the 7.2 mg semaglutide dose than with lower doses of the GLP-1 inhibitor.
Smaller biotech companies without the regulatory resources of big pharma should approach the UK medicines regulator and health technology appraisal body for early, informal discussions on how to generate the right evidence.
Asieris Pharmaceuticals' hexaminolevulinate, for treating high-grade squamous intraepithelial lesions, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Japan's regulatory authorities recommend approval of products including a cell therapy, while setting reimbursement prices of newly approved drugs and cutting some others following cost-effectiveness assessment.
Daiichi Sankyo’s MMR Vaccine, Ultragenux’s triheptanoin also won approval recommendations.
The FDA’s contrasting decisions on leucovorin and idebenone reveal a tightening regulatory stance where only therapies showing strong mechanistic rationale and large, credible treatment effects can overcome the limitations of nontraditional evidence sources.
The US FDA Commissioner's National Priority Voucher program is speeding clearance of products advancing agency priorities, but are recent quick approvals more attributable to the Real-Time Oncology Review (RTOR) program?
Idvynso, Merck & Co.'s oral once-daily combination of doravirine and Japan-originated molecule islatravir, has been granted its global-first approval in Japan, ahead of the US.
Two recent CNPV approvals point to a practical submission-to-approval cadence of roughly three months, while the FDA’s filing‑to‑decision clock signals an even shorter timeframe.
The European Medicines Agency’s human medicines committee, the CHMP, has voted against the pan-EU approval of Vanda Pharmaceuticals’ Iloperidone, marking a third rejection for the drug. The agency backed 12 products for EU approval and one for use outside of the bloc.
The European Medicines Agency said that Acoziborole Winthrop would simplify the treatment of first- and second-stage disease caused by Trypanosoma brucei gambiense.
A new regulatory reliance procedure in New Zealand is expected to better allow companies to include the country in their global drug launch plans more easily.
Acoziborole, developed by Sanofi in collaboration with the Drugs for Neglected Diseases initiative, could potentially become the first single-dose oral treatment for sleeping sickness.
Iloperidone is among 13 new drugs that the European Medicines Agency is set to consider this week, as it decides whether they should be granted marketing approval.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include five new products, one of which is Aumseqa (aumolertinib), Hansoh Pharma's treatment for non-small cell lung cancer.
Garetosmab, Regeneron Pharmaceuticals' treatment for adult patients with fibrodysplasia ossificans progressiva, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
The headlines showed a robust tally of new drug approvals from the US FDA in 2025, but cracks are beginning to show that could turn into fissures in the year ahead.
The European Medicines Agency has recommended new uses for nine approved medicines, including Incyte's immunotherapy Zynyz which is poised to become the first EU treatment for squamous cell carcinoma of the anal canal.
Accelerated approvals of novel products rebounded in 2025 as drug development adapted to major pathway changes enacted in the FDA Omnibus Reform Act, but pending applications suggest a potentially bigger impact outside oncology in 2026.