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FDA Approves Kirsty (insulin aspart-xjhz), an Interchangeable Biosimilar to NovoLog
BRIDGEWATER, N.J., United States and BENGALURU, Karnataka, India: July 15, 2025 -- Biocon Biologics Ltd (BBL), a fully integrated global...
U.S. FDA Approves Kerendia (finerenone) to Treat Patients with Heart Failure with Left Ventricular Ejection Fraction ≥40% Following Priority Review
WHIPPANY, N.J., July 14, 2025 – Bayer today announced that the U.S. Food and Drug Administration (FDA) approved Kerendia (finerenone) to treat patients...
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 Updated Label for Lilly's Kisunla (donanemab-azbt) with New Dosing in Early Symptomatic Alzheimer's Disease
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved a label update with a new recommended titration...
No Risks Seen With Early Childhood Exposure to Aluminum-Adsorbed Vaccines
Early childhood exposure to aluminum-adsorbed vaccines is not associated with an increased risk for autoimmune, atopic or allergic, or neurodevelopmental...
FDA Sends Warning Letters to Companies Selling Illegal Opioid Compound
The U.S Food and Drug Administration has issued seven warning letters to companies illegally marketing products containing 7-hydroxymitragynine (7-OH),...
High Dietary Inflammatory Index Tied to Increased Prevalence of Eczema
A high dietary inflammatory index (DII), which quantifies the inflammatory potential of diet, is associated with increased prevalence of atopic dermatitis...
ENDO: Superior Weight Loss Seen With Tirzepatide and Menopausal Hormone Therapy Use
In postmenopausal women with overweight or obesity receiving tirzepatide, use of menopausal hormone therapy (MHT) is associated with superior weight loss...
ENDO: Sweeteners, Genetic Predisposition Independently Linked to Early Puberty
Sweetener consumption and genetic predisposition are independently associated with the risk for central precocious puberty (CPP), according to a study...
FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine
The U.S. Food and Drug Administration today announced seven recent warning letters sent to companies for illegally marketing products containing 7-hydroxymitragynine,...
Study Finds No Link Between Vaccine Aluminum and Health Problems
TUESDAY, July 15, 2025 — A new study of more than 1.2 million people found no link between aluminum in childhood vaccines and long-term health problems,...
Most Major Ice Cream Brands Will Remove Synthetic Dyes by 2028
TUESDAY, July 15, 2025 — About 90% of the ice cream sold in the U.S. will no longer contain artificial dyes by 2028, federal health officials announced. Roughly...
FDA Approves Gardenia-Based Blue Dye for Use in Foods and Drinks
TUESDAY, July 15, 2025 — A natural blue food coloring made from gardenia fruit has been approved by the U.S. Food and Drug Administration (FDA). The...
Adagene Announces Regulatory Update on Clinical Development Plan for Muzastotug in Microsatellite Stable Colorectal Cancer Following Productive Type B (End of Phase 1) Meeting with FDA
SAN DIEGO and SUZHOU, China, July 15, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene or the Company”) (Nasdaq:...
Shorla Oncology Announces FDA Orphan Drug Designation for SH-110 to Treat Rare Brain Cancer Using Oral Liquid
(BUSINESS WIRE)-- July 15, 2025 -- Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the U.S....
Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging
UPDATE July 14, 2025 – Sandoz, Inc. (“Sandoz”) is initiating a voluntary nationwide recall expansion of one additional lot of Cefazolin...
Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer
(BUSINESS WIRE)--Jul. 14, 2025-- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development...
Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Sucralfate Tablets USP 1 Gram Within Expiry
Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company...
Popular Chronic Pain Med, Gabapentin, Linked To Dementia Risk
FRIDAY, July 11, 2025 — A drug used to treat seizures, nerve pain and restless leg syndrome might be linked with increased risk of dementia, a new...
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,...
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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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- Kirsty Kirsty (insulin aspart-xjhz) is a rapid acting human insulin analog interchangeable biosimilar to NovoLog (insulin aspart) indicated to...
- 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...
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