FDA

FDA and MHRA Launch New Liaison Programme to Strengthen Regulatory Collaboration

Yuvraj — Wed, 17 Jun 2026 09:27:27 +0000

The US Food and Drug Administration (FDA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have announced a significant new liaison programme designed to deepen regulatory collaboration between the two agencies. The initiative, unveiled during the DIA Global Annual Meeting held from 14 to 18 June in Philadelphia, focuses on medical devices, artificial […]

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Sanofi Advances T1D Treatment with Tzield FDA Approval in US

Yuvraj — Tue, 16 Jun 2026 13:15:40 +0000

The US Food and Drug Administration (FDA) has granted accelerated approval to Sanofi’s Tzield (teplizumab-mzwv) for children aged eight to 17 years who have recently been diagnosed with stage 3 type 1 diabetes (T1D). The decision allows the therapy to be used to delay the decline in endogenous insulin production and marks the first disease-modifying […]

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Pfizer’s Hympavzi Wins FDA Expanded Approval for Haemophilia A and B

Yuvraj — Thu, 11 Jun 2026 07:19:17 +0000

Pfizer has secured an expanded indication approval from the US Food and Drug Administration (FDA) for Hympavzi (marstacimab-hncq), broadening its use in the treatment of haemophilia A or B. The updated approval extends coverage to patients aged 12 years and older who have inhibitors, and also to children between six and 11 years of age, […]

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FDA Grants Approval for Chronic Hepatitis Delta Virus Treatment from Gilead Sciences

Yuvraj — Sat, 23 May 2026 08:40:28 +0000

The U.S. Food and Drug Administration (FDA) has granted approval for Gilead Sciences’s Hepcludex, an experimental drug designed to treat chronic hepatitis delta virus (HDV). This rare and severe liver disease, which exclusively affects individuals already living with hepatitis B, can lead to organ failure, cancer, scarring, and death. Until this recent regulatory action, there […]

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FDA Advances Real-Time Clinical Trials With AstraZeneca, Amgen

Yuvraj — Fri, 01 May 2026 10:18:20 +0000

The U.S. Food and Drug Administration has unveiled a new regulatory initiative to enable real-time clinical trials, marking a structural shift in how drug development data is reviewed. The program, already supported by AstraZeneca and Amgen, introduces a model where safety and efficacy data are transmitted continuously to regulators rather than submitted after trial completion. […]

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FDA Issues 3 Priority Vouchers for Psychedelic Drug Firms

Yuvraj — Sat, 25 Apr 2026 08:48:26 +0000

The US Food and Drug Administration has awarded three additional Commissioner’s National Priority Vouchers under its accelerated regulatory framework, targeting companies developing psychedelic-based therapies. The move follows President Donald Trump’s April 18 executive order aimed at advancing mental health treatment innovation. While the agency did not officially disclose the recipients, industry sources identified them as […]

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Trump Order Targets Faster Psychedelic Drug Reviews by FDA

Yuvraj — Thu, 23 Apr 2026 07:08:09 +0000

The Trump administration has introduced a new executive order designed to accelerate Psychedelic Drug Reviews, marking a notable policy move aimed at expediting regulatory pathways for emerging mental health treatments. The directive focuses on advancing FDA evaluation processes for investigational psychedelic therapies, particularly those addressing conditions such as post-traumatic stress disorder (PTSD), anxiety, and depression. […]

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FDA Advisory Panel to Assess Oversight of Peptide Substances

Yuvraj — Fri, 17 Apr 2026 12:18:52 +0000

The U.S. Food and Drug Administration is preparing to revisit its stance on a group of peptide substances, as its Pharmacy Compounding Advisory Committee schedules a summer meeting that could influence how these products are regulated. The FDA advisory panel is set to evaluate whether certain peptides currently restricted from compounding use should be reconsidered, […]

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FDA Outlines Genome Editing Safety Guidance for Therapies

Yuvraj — Fri, 17 Apr 2026 04:42:53 +0000

The U.S. Food and Drug Administration has released a draft guidance outlining safety assessment standards for human gene therapy products that incorporate genome editing technologies, marking a step toward streamlining development pathways for advanced therapies. Announced on April 14, 2026, the document is designed to support sponsors in evaluating risks associated with genome editing while […]

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FDA Seeks Input on National Priority Voucher Pilot Program

Yuvraj — Fri, 27 Mar 2026 06:52:42 +0000

The U.S. Food and Drug Administration has initiated a new phase of stakeholder engagement for its national priority voucher pilot program, announcing a public meeting scheduled for June 12, 2026, alongside a Federal Register Notice seeking industry feedback. The move reflects the agency’s ongoing efforts to refine expedited regulatory pathways while maintaining established scientific standards. […]

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