FDA

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The U.S. Food and Drug Administration has released a draft guidance outlining safety assessment standards for human gene therapy products that incorporate genome editing technologies, marking a step toward streamlining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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Cosentyx Secures FDA Approval for Paediatric HS Treatment

Yuvraj — Tue, 17 Mar 2026 10:16:50 +0000

Novartis has received approval from the US Food and Drug Administration (FDA) for Cosentyx (secukinumab) for the treatment of paediatric patients aged 12 years and above with moderate to severe hidradenitis suppurativa (HS). The FDA approval expands the therapy’s use to a younger patient population and positions Cosentyx as the first interleukin-17A (IL-17A) inhibitor approved […]

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US FDA Approves Leucovorin for Rare Autism-Like Disorder

Yuvraj — Thu, 12 Mar 2026 06:15:46 +0000

The U.S. Food and Drug Administration on Tuesday authorized the use of leucovorin, a long-established generic medicine, for the treatment of a rare genetic disorder associated with autism-like symptoms. The decision does not extend to children diagnosed with autism more broadly, despite earlier suggestions last year that the drug might help address autism symptoms. Regulators […]

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Enhertu Priority Review in HER2-Positive Early Breast Cancer

Yuvraj — Wed, 11 Mar 2026 08:14:38 +0000

The supplemental Biologics License Application – sBLA for Enhertu – trastuzumab deruxtecan by AstraZeneca and Daiichi Sankyo has been accepted as well as granted Priority Review in the U.S. when it comes to the treatment of adult patients with HER2‑positive early breast cancer who happen to have residual invasive disease after neoadjuvant HER2‑targeted therapy. Enhertu […]

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FDA Approves Monthly Rybrevant Faspro for EGFR-Mutated NSCLC

Yuvraj — Thu, 19 Feb 2026 08:31:17 +0000

Johnson & Johnson (J&J) has obtained approval from the US Food and Drug Administration (FDA) for a revised dosing schedule of Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), introducing a once-monthly administration option for patients with advanced, epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). Rybrevant Faspro is used in combination with Lazcluze (lazertinib) and […]

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