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FDA Approves Palsonify (paltusotine) for the Treatment of Acromegaly in Adults

SAN DIEGO – September 25, 2025 – Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that the U.S. Food and Drug Administration...

FDA Approves Inluriyo (imlunestrant) for Adults with ER+, HER2-, ESR1-Mutated Advanced or Metastatic Breast Cancer

Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Inluriyo (imlunestrant, 200 mg tablets),...

FDA Approves Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) Subcutaneous Injection Formulation of Keytruda for Use in Solid Tumors

(BUSINESS WIRE) September 19, 2025 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug...

FDA Grants Accelerated Approval to Forzinity (elamipretide hydrochloride) for the Treatment of Barth Syndrome

NEEDHAM, Mass., Sept. 19, 2025 /PRNewswire/ — Stealth BioTherapeutics Inc. (the “Company” or “Stealth”), a...

Risk for Behavioral Problems Elevated for Children With Allergic Rhinitis

Children with allergic rhinitis (AR) have an increased risk for behavioral problems (BPs), which is partly mediated by sleep disturbance (SD), according...

Nonoptimal Levels of Traditional Risk Factors Almost Universal Before CVD

Almost all adults have nonoptimal levels of one or more traditional risk factors before being diagnosed with cardiovascular disease (CVD), according to...

Recommendations Issued for Diagnosing, Managing Gastroparesis

In a clinical practice guideline issued by the American Gastroenterological Association and published in the October issue of Gastroenterology, conditional...

Natural Language Processing Algorithms Can ID High-Risk Childhood Asthma Subgroup

Natural language processing (NLP) algorithms can identify a subgroup of children with asthma who have a high risk for acute respiratory infections (ARI),...

Kennedy Says FDA Reviewing Safety of Abortion Pill Mifepristone

MONDAY, Sept. 29, 2025 — The U.S. Food and Drug Administration (FDA) is reviewing the safety of mifepristone, a drug used in medication abortions...

Frozen Meals Sold at 3 Chains Linked to Listeria Outbreak

MONDAY, Sept. 29, 2025 — Federal health officials have expanded their probe into a listeria outbreak that has claimed four lives, and affected at...

Doctors Warn Against Mouth Taping During Sleep

MONDAY, Sept. 29, 2025 — Taping your mouth shut before bed may seem like a quick fix for better sleep, but doctors are raising serious alarms about...

Hidden Signs Of Rheumatoid Arthritis Found In Blood Long Before Diagnosis

MONDAY, Sept. 29, 2025 — An invisible storm might rage for years inside the bodies of people at risk for rheumatoid arthritis, prior to any joint...

FDA Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa (vandetanib)

The U.S. Food and Drug Administration today removed the Risk Evaluation and Mitigation Strategies (REMS) program for Caprelsa (vandetanib), a thyroid cancer...

Women With Dense Breasts Benefit From Advanced Cancer Screening Procedures

WEDNESDAY, Sept. 24, 2025 — Women with dense breasts could benefit from an advanced cancer screening procedure called molecular breast imaging (MBI),...

FDA Issues Complete Response Letter (CRL) for Apitegromab as a Treatment for Patients with Spinal Muscular Atrophy (SMA) Solely Related to Observations Identified at Catalent Indiana LLC Fill-Finish Facility

(BUSINESS WIRE)--Sep. 23, 2025-- Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to dramatically improving the lives...

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Recently added consumer and prescribing information: Palsonify, Inluriyo, Forzinity, Enbumyst, Inlexzo, Nuvaxovid, mNEXSPIKE, Cyklx, Papzimeos, Brinsupri

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Latest FDA New Drug Approvals

  • Palsonify Palsonify (paltusotine) is a somatostatin receptor agonist indicated for the treatment of adults with acromegaly who had an inadequate...
  • Inluriyo Inluriyo (imlunestrant) is an estrogen receptor antagonist indicated for the treatment of adults with ER-positive, HER2-negative, ESR1-...
  • Keytruda Qlex Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) is a programmed death receptor-1 (PD-1)-blocking antibody and endoglycosidase...

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