The Rasonque pancreatic cancer treatment from Revolution Medicines has received US Food and Drug Administration (FDA) approval for certain patients with metastatic disease. The once-daily oral medicine, also known as daraxonrasib, is approved for patients who have received previous treatment or cannot undergo combination chemotherapy. It targets several forms of the RAS protein, which plays a significant role in driving…
Tag: FDA
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Oral Phenylephrine Phase-Out Puts OTC Brands Under Review
South Africa’s medicines regulator is under mounting pressure from pharmaceutical manufacturers. This comes after it signalled it may phase out oral phenylephrine in over-the-counter (OTC) cold and flu medicines. The South African Health Products Regulatory Authority (SAHPRA) says the concern is simple: the ingredient may not work as a nasal decongestant when taken by mouth. Phenylephrine still appears in long-standing…
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Animal Testing Alternatives: New FDA Guidance Insights
US regulators are stepping up efforts to reduce animal use in early drug development. On 18 March 2026, the US Food and Drug Administration issued draft guidance encouraging companies to swap or reduce animal studies where credible human-relevant tools exist. This marks an important recognition of the growing range of animal testing alternatives available to researchers. The FDA says a…
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FDA Biosimilar Development Guidance Targets Treatment Costs
\n\nBiologic medicines are made from living cells and are among the most expensive therapies available. While they account for only 5% of all prescriptions, they are responsible for a staggering 51% of total drug spending in the United States. To address this imbalance, the FDA is prioritising the expansion of the biosimilar market.\n\n\n\nThe new FDA biosimilar development guidance focuses on…
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FDA Unpredictable: Moderna Challenges the Agency
Moderna has launched a rare public attack on the US Food and Drug Administration, warning that an “unpredictable” regulator could weaken America’s lead in drug innovation. During the call, company leaders specifically argued that the FDA’s unpredictable decision-making undermines industry momentum. The comments came during the company’s Friday analyst call. This was just days after the FDA declined to accept…
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FDA Generic Drug Review Boosts US Drug Manufacturing
The US Food and Drug Administration (FDA) has announced the launch of a new pilot programme. This programme aims to accelerate the review process for generic drugs. Companies research, develop, and manufacture these drugs entirely within the United States. The initiative aims to incentivise pharmaceutical companies to onshore their operations. It strengthens the domestic supply chain and reduces America’s heavy…
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HHS Restructuring Plan Blocked by Federal Court
A US Federal Appeals Court has maintained a block on the Trump administration’s ambitious and controversial plan to overhaul the Department of Health and Human Services (HHS). This move would have resulted in 10,000 job losses. Additionally, it would have caused a significant restructuring of key public health agencies. A three-judge panel of the Boston-based 1st US Circuit Court of…
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Are New Cancer Treatments Worth the Price?
A significant number of cancer drugs approved since 2000, as reviewed by Bloomberg News, have never been definitively shown to extend patient survival for their approved uses. This raises questions about the growing cost of cancer treatments. The landscape of cancer treatment has been revolutionized over the past three decades, with over 200 new cancer drugs greenlit by the US…
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FDA warns Aspen Pharmacare over eye drop production standards
The US Food and Drug Administration (FDA) has raised serious concerns regarding the manufacturing standards of eye drops produced by Aspen Pharmacare at its sterile facility in Gqeberha, South Africa. In a warning letter, the FDA highlighted potential risks of microbial contamination due to inadequate controls. The FDA’s warning letter, published following a September audit, revealed that Aspen’s manufacturing processes…