FDA

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The U.S. Food and Drug Administration has released a draft guidance outlining safety assessment standards for human gene therapy products that incorporate genome editing technologies, marking a step toward streamlining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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First GLP-1 Pill for Obesity by Novo Nordisk Approved by FDA

Yuvraj — Wed, 24 Dec 2025 13:44:04 +0000

The U.S. Food and Drug Administration – FDA on December 22, 2025, gave an approval to the first GLP-1 pill for obesity from Novo Nordisk, the Wegovy maker. This can surely be called a landmark decision, which, as per health experts, could open up treatment access to more patients. Novo Nordisk said it anticipates the first […]

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Proactive Risk Management as a Core Capability in Pharma Development

Yuvraj — Wed, 24 Dec 2025 09:35:21 +0000

Risk management in pharma is often treated as a reactive compliance box-ticking exercise. This article argues for reframing risk as a strategic competitive advantage. It details proactive frameworks like the "Excipient Exclusion Filter," Decision Quality (DQ) matrices, and "pre-mortem" analyses that allow development teams to anticipate failure modes and engineer them out of the pipeline before they occur.

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Aligning Scientific Innovation with Commercial Reality in Drug Development

Yuvraj — Wed, 24 Dec 2025 09:32:21 +0000

The "Valley of Death" in pharma is no longer just about scientific failure; it is about commercial irrelevance. This article examines the critical need to align R&D ambition with market reality early in development. It explores the evolution of the Target Product Profile (TPP) into the Target Value Profile (TVP), the role of the "commercial scientist," and strategies for integrated evidence generation that satisfy both regulators and payers.

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