December 03, 2025

Ranitidine’s return 'unlikely to provide greater clinical benefit'

New formulation incorporates stronger manufacturing controls and stability measures to prevent NDMA from forming.

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November 21, 2025

Which Antidepressants Shift Physiology?

Researchers found differences in how antidepressants affect weight, blood pressure, heart rate, and other physiological parameters.

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November 18, 2025

Plozasiran Wins FDA Nod for FCS

Arrowhead’s small interfering RNA therapy reduced triglycerides and lowered pancreatitis risk in the phase 3 PALISADE trial, providing a quarterly self-administered option for patients with familial chylomicronemia syndrome.

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November 10, 2025

FDA Proposes Removal of Box Warnings

The FDA proposed updates to menopausal hormone therapy labeling to reflect current evidence on benefits and risks.

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October 29, 2025

FDA Pushes Faster, Cheaper Route for Biosimilar Approval

The FDA released new draft guidance to streamline biosimilar development.

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October 24, 2025

Elinzanetant Approved for Menopausal Hot Flashes by FDA

Bayer’s dual neurokinin 1 and 3 receptor antagonist elinzanetant (Lynkuet) reduced the frequency and severity of menopausal vasomotor symptoms in phase 3 OASIS trials, providing a once daily, nonhormonal treatment option for moderate to severe hot flashes.

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October 20, 2025

FDA Okays First Oral GLP-1 for CV Risk

Novo Nordisk’s once-daily GLP-1 tablet reduced major adverse cardiovascular events in high-risk adults, including those without prior heart attack or stroke.

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October 20, 2025

Which Hair Loss Treatments Truly Deliver Results?

Researchers compare prescription and over-the-counter treatments for male hair loss to determine which best improve hair density.

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October 17, 2025

FDA Awards Nine CNPV Vouchers to Speed Reviews

Pilot aims to expedite access to high‑impact therapies by streamlining FDA review and strengthening sponsor–agency collaboration.

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