Pharming Group receives Complete Response Letter from U.S. FDA for sNDA for Joenja® (leniolisib) in children aged 4 to 11 years with APDS

Fabrice Chouraqui, Chief Executive Officer of Pharming, commented: ...

ResMed (RMD) Q2 2026 Earnings Call Transcript

Thank you, Sally, and good morning, good afternoon, good evening to all of our shareholders, and welcome to all to ResMed's second quarter fiscal year 2026 earnings call. For this March and the June ...

Pharma Data Integrity Auditor Masterclass Training Course: Department-Level Audit Strategies, Critical Findings, and Regulatory Expectations (Online Event: Apr 22nd - Apr 23rd ...

Opportunities lie in enhancing data integrity auditing skills within pharmaceutical manufacturing, focusing on GxP audits. Companies can capitalize by offering comprehensive training that delves into ...
Yahoo

Exclusive-US FDA delays two drug reviews in new voucher program after safety, efficacy concerns

Add Yahoo as a preferred source to see more of our stories on Google. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29 ...
Newsweek

FDA Issues Most Serious Risk Level for Cheese Recall

The recall, identified by Event ID 98053, was initiated on November 21, 2025, and officially classified by the FDA on January 6, 2026. It remains ongoing, with products distributed to retail stores ...
Nature

2025 FDA approvals

Drug developers secured approvals for 46 new therapeutic agents from the FDA’s Center for Drug Evaluation and Research (CDER) in 2025. This cohort brings the 5-year average down a touch, to 48 new ...
Newsday

2 types of holiday bark snacks sold by Aldi recalled, FDA reports

Two types of holiday bark snacks sold nationally by Aldi have been voluntarily recalled because they may contain undeclared allergens that could pose a risk of serious or life-threatening allergic ...
Penn Live

These popular nasal sprays could cause life-threatening infections, FDA warns

A New Mexico company has expanded its recall of homeopathic nasal sprays that contain yeast/mold and microbial contamination. MediNatura New Mexico, Inc., last week recalled one lot of ReBoost Nasal ...
Charlotte Observer

Nasal spray recall for yeast/mold and microbial contamination includes Publix

WEDNESDAY UPDATE: The recall has been expanded. Publix posted Monday that its stores are included in last week’s recall of ReBoost Nasal Spray, which “has been found to contain yeast/mold and ...
Reuters

FDA intends to put most serious warning on COVID vaccines, CNN reports

Dec 12 (Reuters) - The U.S. Food and Drug Administration intends to put a "black box" warning on COVID-19 vaccines, CNN reported on Friday, citing two people familiar with the agency's plans. The ...
Forbes

FDA Announcements Spark Vigorous Debate, Controversy

The U.S. Food and Drug Administration is often described as the most influential scientific regulator in the world. Its decisions shape global drug development, investment, and patient access. But in ...