Sun Pharma receives US FDA approval for drug to treat alopecia areata | Business Standard
Excerpt from Business Standard: “Sun Pharmaceutical Industries has received US Food and Drug Administration (FDA) approval for LEQSELVI (deuruxolitinib) that is used for treating an autoimmune disorder in adults. Alopecia areata, which is characterised by hair loss, affects some 700,000 people in the United States, with 300,000 experiencing severe forms of the condition. Current treatments have shown slow progress, prompting some patients to seek alternative solutions.” Read more.
FDA’s ODAC recommends for phase assessment in NSCLC trials | Fierce Pharma
Excerpt from Fierce Pharma: “The FDA’s Oncologic Drugs Advisory Committee (ODAC) has unanimously called for a revamp of perioperative clinical trial designs in resectable non-small cell lung cancer (NSCLC) to include assessment of the contribution of each treatment phase. The 11-0 vote comes in response to AstraZeneca’s application for approval of Imfinzi as a treatment before and after tumor-removal surgery in early-stage NSCLC. The regimen includes pre-operative use of Imfinzi plus chemotherapy, followed by post-operative use of Imfinzi as a monotherapy.” Read more.
Compounded Ozempic overdoses likely caused by incorrect prescriptions, FDA warns | Forbes
Excerpt from Forbes: “The Food and Drug Administration on Friday issued a notice to health care providers and patients about dosing errors with compounded versions of Novo Nordisk’s weight loss drug Ozempic, after the agency received reports of possible overdoses from patients who took up to 20 times the prescribed dosage.” Read more.
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