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Taletrectinib Gains FDA Approval for Locally Advanced or Metastatic ROS1+ NSCLC

Pharmacy Times

The FDA approved taletrectinib (Ibtrozi; Nuavtion Bio Inc) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non–small cell lung cancer (NSCLC). It demonstrated high response rates with durable benefit and intracranial activity and was well-tolerated among patients, according to the FDA.

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Sarepta Therapeutics to cut 500 jobs amid restructuring

Pharmaceutical Technology

July 17, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The announcement included updates on Elevidys’ label changes for Duchenne muscular dystrophy treatment. It also announced an update regarding its Elevidys label changes for Duchenne muscular dystrophy (DMD) treatment. Credit: luchschenF/Shutterstock.com.

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Leo puts target on Dupixent in US as FDA clears tralokinumab

pharmaphorum

Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. Dupixent’s label currently calls for dosing every two weeks for all patients. Leo now says it will start rolling the new product out in February.

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FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

pharmaphorum

The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. Broad label questioned. billion in 2027.

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RWE There Yet? FDA’s New Pilot Program Seeks to Help Usher in a New Era for Real World Evidence

The FDA Law Blog

355g(a), directed FDA to “establish a program to evaluate the potential use of real world evidence” both “to help to support the approval of a new indication” and “to help to support or satisfy postapproval study requirements.” The sponsor and FDA reach agreement on the study design information to be publicly disclosed.

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AbbVie files Qulipta for chronic migraine prevention

pharmaphorum

Qulipta (atogepant) is already approved for prevention of episodic migraine – where attacks are less frequent – getting the green light from the FDA last September for this use a few months after Biohaven and Pfizer’s Nurtec ODT (rimegepant). The post AbbVie files Qulipta for chronic migraine prevention appeared first on.

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Proposed LDT Rule Raises Many Questions but Provides Few Answers

The FDA Law Blog

Javitt & Philip Won — As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. By Allyson B. Mullen & Gail H.

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