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US FDA

Curated news coverage, institutional background, regulatory filings, and investigative reporting across RDU Global.

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Last Updated: Just Now
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World Politics & Diplomacy 11h ago

Trump FDA Pick Heidi Overton Sidesteps Question on Whether the President Can Be Wrong

Heidi Overton, President Donald Trump's pick to lead the Food and Drug Administration, faced pointed questioning over vaccines, birth control and vaping during her confirmation hearing. The exchange underscored how closely the agency's future could be tied to political loyalty as much as scientific judgment. Overton declined to say whether Trump can ever be wrong, a moment that sharpened concerns among lawmakers and public health observers about the independence of the nation's top drug regulator.

By RDU Global Correspondent5 min read
Global Markets & Equities11 Oct 2026, 12:38 PM IST

US FDA Approves Asahi Kasei’s HOVILPRI for Persistent Herpes Infections

The US Food and Drug Administration has approved Asahi Kasei’s HOVILPRI, a pritelivir tablet for immunocompromised adults with mucocutaneous herpes simplex virus lesions that are refractory to standard antiviral treatment, with or without resistance. The decision marks a notable advance in a niche but clinically urgent market, offering an oral option where treatment has often been limited and difficult to manage. The approval also gives Asahi Kasei a meaningful regulatory win in the United States and could reshape care pathways for a small but high-need patient population.

5 min readRead →
Global Markets & Equities11 Oct 2026, 04:47 AM IST

US FDA Clears Asahi Kasei’s Hovilpri for Persistent Herpes Infections

The U.S. Food and Drug Administration has approved Asahi Kasei’s Hovilpri, a treatment for refractory herpes simplex virus lesions in immunocompromised adults, marking a notable regulatory win for the Japanese industrial group’s healthcare portfolio. The decision could expand access to an oral option for patients with persistent or resistant infections, a category that has often required more burdensome intravenous care.

5 min readRead →
Healthcare, Pharma & Life SciencesSpecial Report (Sept 27, 2026)

USFDA Scrutiny vs. Biosimilar Leadership: The Strategic Dilemma Facing Indian Pharma’s Generic Champions

Indian pharma’s biggest listed manufacturers are being pulled in opposite directions: toward higher-value biologics, complex injectables and biosimilars, and back toward the basics of manufacturing discipline under intensifying USFDA scrutiny. For Sun Pharma, Dr. Reddy’s and Cipla, the strategic prize is clear—less commoditised growth, better margins and a stronger moat against price erosion in the US generics market. But the regulatory cost of failure is rising, with Form 483 observations, warning letters and import-risk disruptions forcing expensive remediation and slowing launches. The deeper challenge is structural. India’s generic champions still depend on the US for a large share of profits while relying on China for critical APIs and intermediates. That leaves them exposed to two forms of concentration risk at once: compliance concentration in FDA-inspected plants and supply-chain concentration in upstream chemistry. The companies are now spending billions of rupees to diversify APIs, automate plants and build biologics platforms, but the transition is uneven, capital-intensive and vulnerable to any fresh USFDA setback.

7 min readRead →

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Donald Trump(2)Washington, D.C.(1)Supreme Court of India(1)