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US FDA Approves PADCEV Plus Keytruda for Muscle-Invasive Bladder Cancer
The US Food and Drug Administration (FDA) has approved PADCEV plus Keytruda as the first and only platinum-free neoadjuvant and adjuvant treatment for adults with Muscle-Invasive Bladder Cancer (MIBC), regardless of cisplatin eligibility.
Takeda and Indonesia Partner to Expand Access to Plasma-Derived Medicines
Takeda and Indonesia have partnered to strengthen healthcare resilience, expand access to plasma-derived medicines, and establish a national plasma donation ecosystem with an initial USD 30 million investment.
US FDA Proposes New Rule to Modernise Drug Manufacturing Registration
The US Food and Drug Administration (FDA) has proposed a new rule to modernise drug manufacturing registration, streamline advanced distributed manufacturing, and improve visibility into foreign drug supply chains.
OKYO Pharma Receives FDA Support to Advance Urcosimod into Global Phase 3 Trial
Positive feedback from the US FDA has reinforced OKYO Pharma's clinical development strategy for urcosimod, with the company preparing to launch a global Phase 3 trial for neuropathic corneal pain, a debilitating eye disorder that currently lacks FDA-approved therapies.
FRONTIER4 extension study demonstrates sustained safety, low bleeding rates and flexible dosing across children, adolescents and adults, while new data on concizumab highlights reduced bleeding episodes in pediatric patients with hemophilia.
India and Australia Sign CSIR-TKDL Pact to Protect Traditional Knowledge
CSIR and IP Australia have signed a Traditional Knowledge Digital Library (TKDL) access agreement at the India-Australia Summit to strengthen traditional knowledge protection.
Government Revises Drugs Rules to Regulate High Alcohol-Content Medicines
India has strengthened regulation of high alcohol-containing drug formulations by bringing products with over 12 percent v/v ethyl alcohol under Schedule H1 and ending their Schedule K exemption.
Torrent Pharma Recalls Select Semalix Injection Batches Following API-Related Quality Issue
Torrent Pharmaceuticals has initiated a recall of select batches of Semalix Injection 2 mg and 4 mg after certain semaglutide batches failed quality specifications due to an API-related issue.
MHRA Approves Use of UK-Donor Plasma for Five Additional Life-Saving Medicines
The UK's Medicines and Healthcare products Regulatory Agency has approved the use of UK-donor plasma for producing five additional plasma-derived medicines after determining that the risk of variant Creutzfeldt-Jakob disease (vCJD) transmission is negligible. The decision is expected to improve the resilience of the UK's plasma medicine supply chain.
Roche Receives CE Mark for Automated Blood Test to Detect Latent Tuberculosis Infection
Roche's Elecsys IGRA TB test enables tuberculosis infection screening with results in under 24 hours, offering faster laboratory workflows and supporting efforts to improve TB diagnosis and control.
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