FDA Approves New Prostate Cancer Imaging Agent Gozellix®
Gozellix®, after radiolabeling with 68 Ga, is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive ...
Food Safety News1d
FDA puts food safety rule on hold
The FDA is delaying enforcement of the Food Traceability Rule, which has been in the works for 14 years, by another 30 months ...
Novartis1d
Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G)
Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G) Fabhalta is the only oral alternative complement pathway ...
FDA approves Johnson & Johnson’s TREMFYA in Crohn’s disease
Johnson & Johnson announced that the FDA has approved TREMFYA, or guselkumab, the first and only IL-23 inhibitor ...
'We've Been Getting Picked Off': Product Liability Lawsuits Are Struggling
Attorney Simon Purnell of Griffin Purnell said he thinks the courts' view of preemption is a "fundamental misunderstanding of ...
This cutting edge hair loss treatment is a repurposed drug from the 1990s
Rogaine was approved by the Food and Drug Administration in 1988, the first drug to win the agency’s endorsement for male ...
Zacks Investment Research on MSN2d
FDA Accepts RDY & ALVO's Prolia & Xgeva Biosimilar BLA for Review
Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the ...
Why cheaper alternatives to weight-loss drugs like Wegovy, Zepbound will be tougher to get
The versions affected are called compounded medications, which have the same active ingredients as the name brands. The ...
Scientist whose work led FDA to ban food dye says agency overstated risk
When the FDA announced in January, before President Joe Biden's term ended, that it would ban a dye called red dye No. 3 in ...
WGN Radio 7203d
FDA staff return to crowded offices, broken equipment and missing chairs
People are looting chairs from conference rooms and other buildings,” a staffer said. “We have no supplies. People are hunting around all of the buildings on campus for pads of paper and other ...
Politico14d
FDA nominee pitches AI application review
“So that we don’t learn five years after Vioxx was approved that 38,000 Americans died from it,” he said. Open questions: But the Johns Hopkins surgeon also said the FDA could potentially ...