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Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine, Spikevax in Children Aged 6 Months Through 11 Years at Increased Risk for COVID-19 Disease

CAMBRIDGE, MA / ACCESS Newswire / July 10, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration...

FDA Approves Ekterly (sebetralstat) the First and Only Oral On-demand Treatment for Hereditary Angioedema (HAE)

CAMBRIDGE, Mass. & SALISBURY, England, July 7, 2025 (BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food...

Killer Whales Show a Softer Side, Sharing Food With People

SATURDAY, July 12, 2025 — They’re known as "killer whales," but orcas have a surprisingly soft and even generous side."Orcas often share food with...

Adding Anxiety as Qualifier for Medical Cannabis Increases Number of Certifications

Adding anxiety disorders as a qualifying condition for medical cannabis in Pennsylvania was associated with an increase in certifications, according to...

Immune Checkpoint Inhibitor Affordability Tied to Widening Survival Disparity

The introduction of immune checkpoint inhibitors (ICIs) was associated with a widening survival disparity between those with private insurance and those...

Gabapentin for Back Pain Linked to Increased Risk for Dementia, MCI

For adults with chronic low back pain, gabapentin prescription is associated with an increased risk for dementia and mild cognitive impairment (MCI), according...

Early-Onset Neonatal Sepsis Linked to Childhood Epilepsy

Early-onset neonatal sepsis and meningitis are associated with an increased risk for childhood epilepsy, according to a study published online July 7 in...

About 1 in 3 U.S. Teens Now Have Prediabetes, New CDC Data Shows

FRIDAY, July 11, 2025 — A new government estimate shows that nearly 1 in 3 U.S. teens have prediabetes, putting them at risk for Type 2 diabetes...

Ritz Peanut Butter Crackers Recalled Over Labeling Mistake

FRIDAY, July 11, 2025 — A labeling mistake has led to a nationwide recall of four different types of Ritz Peanut Butter Cracker Sandwich cartons,...

RFK Jr. Cancels Key U.S. Health Panel Meeting Without Warning, Raising Concerns

FRIDAY, July 11, 2025 — U.S. Health Secretary Robert F. Kennedy Jr. canceled a meeting of government health panel that helps guide what preventive...

Ultragenyx Receives Complete Response Letter from FDA for UX111 AAV Gene Therapy to Treat Sanfilippo Syndrome Type A (MPS IIIA)

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)...

Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy

 Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases,...

'Harmless' Virus Might Trigger Parkinson's Disease, Researchers Say

WEDNESDAY, July 9, 2025 — A common virus once thought harmless to humans might be linked to Parkinson’s disease, a new study says. The germ,...

FDA Grants Fast Track Designation for TRE-515 in Combination with Radiation Therapy for the Treatment of Metastatic Castration Resistant Prostate Cancer

Los Angeles, July 9, 2025 — Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company developing first-in-class...

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Recently added consumer and prescribing information: Zegfrovy, Lynozyfic, Arynta, Harliku, Ibtrozi, Miudella, Opdivo Qvantig, Alyftrek, Crenessity, Ensacove

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Latest FDA New Drug Approvals

  • Ekterly Ekterly (sebetralstat) is an oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema attacks in adults and...
  • Lynozyfic Lynozyfic (linvoseltamab-gcpt) is a bispecific B-cell maturation antigen (BCMA)‑directed CD3 T-cell engager for the treatment of relapsed o...
  • Zegfrovy Zegfrovy (sunvozertinib) is an oral, irreversible, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for the...

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