FDA

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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US FDA Approves Oral Antibiotic for Treatment of Gonorrhea

Yuvraj — Fri, 19 Dec 2025 06:19:06 +0000

On December 12, 2025, the U.S. health regulator went ahead and approved the oral antibiotic by Innoviva for treatment of gonorrhea, which is a common sexually transmitted infection, by way of offering patients an alternative to the injectable drug, which, by the way, was the only recommended treatment till now. Approval of the drug by […]

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FDA Looks to Accelerate Biosimilar Drug Development

Yuvraj — Tue, 25 Nov 2025 13:33:37 +0000

The FDA has gone on to propose certain new policies in order to accelerate biosimilar drug development and at the same time also lower the cost pertaining to biosimilar agents when it comes to cancer as well as any other serious illnesses. These policies go on to include major updates so as to simplify the biosimilarity […]

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