Category: New Drugs
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Centanafadine and a new chapter for ADHD treatment
ADHD treatments have long relied on stimulants like methylphenidate and amphetamines, plus a handful of nonstimulant options. Centanafadine is a different kind of medicine that’s drawing attention because recent clinical trials show promising results and the U.S. Food and Drug Administration has given its application an accelerated review. If approved, centanafadine would be the first
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Vybrique Now FDA Approved: A New, Discreet Oral Film for Erectile Dysfunction
Erectile dysfunction (ED) affects millions of men and can be stressful to manage. A new option just cleared by the U.S. Food and Drug Administration (FDA) may make treatment easier and more discreet: Vybrique™, the first FDA‑approved sildenafil oral film that dissolves on the tongue. What is Vybrique and why does it matter? Vybrique is
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FDA Approves Darzalex Faspro as Part of a New First‑Line Quadruplet Regimen for Multiple Myeloma
Multiple myeloma is a type of blood cancer that affects plasma cells – specialized white blood cells that help the body fight infections. For years, treatment options have steadily improved, but the newest development marks one of the most meaningful steps forward yet. The U.S. Food and Drug Administration (FDA) has approved a new four‑drug
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LYNKUET: New Non‑Hormonal Option for Menopausal Hot Flashes
Hot flashes are one of the most disruptive symptoms of menopause, affecting sleep, mood, work, and overall quality of life. For decades, hormone therapy has been the most effective treatment – but it isn’t right for everyone. That’s why the FDA’s approval of LYNKUET (elinzanetant) in late 2025 has generated so much interest. It’s a
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FDA Approves Exdensur: A Twice‑Yearly Shot That Could Change Life for People with Severe Asthma
Severe asthma can be frightening: sudden attacks, emergency visits, and daily limits on what you can do. On December 16, 2025, the U.S. Food and Drug Administration (FDA) approved Exdensur (depemokimab‑ulaa) as an add‑on maintenance treatment for people aged 12 and older with severe asthma characterized by an eosinophilic phenotype – a type of asthma
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FDA Approves Breyanzi for Relapsed or Refractory Marginal Zone Lymphoma
The U.S. Food and Drug Administration approved Breyanzi for adults with relapsed or refractory marginal zone lymphoma who have already tried at least two prior systemic therapies. This approval expands the list of cancers for which Breyanzi is authorized and gives patients a new option when other treatments have failed. In plain language: what is
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FDA Approves Armlupeg – New Pegfilgrastim Biosimilar
The U.S. Food and Drug Administration has approved Armlupeg™ (pegfilgrastim‑unne) as a biosimilar to Neulasta® (pegfilgrastim) for decreasing the incidence of infection manifested by febrile neutropenia in patients with non‑myeloid malignancies receiving myelosuppressive chemotherapy, and for increasing survival after acute exposure to myelosuppressive radiation. This approval adds another pegfilgrastim biosimilar to the U.S. market and
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FDA Approves Reformulated Ranitidine Following Comprehensive Safety Review
The U.S. Food and Drug Administration (FDA) has approved a reformulated ranitidine tablet after a comprehensive safety review addressing prior concerns about N‑nitrosodimethylamine (NDMA) impurity formation; the approval includes updated storage and handling requirements to mitigate impurity risk and preserve product stability. Background and regulatory context Ranitidine, an H2‑receptor antagonist widely used for gastroesophageal reflux
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FDA Approves Ziftomenib for Acute Myeloid Leukemia
The treatment landscape for acute myeloid leukemia (AML) has recently seen a significant development with the U.S. Food and Drug Administration (FDA) granting full approval to ziftomenib (Komzifti™) for adult patients diagnosed with relapsed or refractory (R/R) AML who harbor a susceptible NPM1 (Nucleophosmin 1) mutation and have no satisfactory alternative treatment options. This landmark
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Breakthrough Cancer Drug With No Detectable Side Effects
A significant nanomedicine breakthrough from Northwestern University, led by Prof. Chad A. Mirkin and documented in the peer-reviewed journal ACS Nano, details the transformation of the chemotherapy agent 5-fluorouracil (5-Fu) into a spherical nucleic acid (SNA) structure. According to both the article and surrounding scientific coverage, this innovation reports unprecedented increases in cancer cell targeting