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FDA Rejects Anti-Sweating Gel

[ Price : $8.95]

FDA issues Botanix Pharmaceuticals a complete response letter on its NDA for sofpironium bromide gel, indicated for treating prima...

Guide on Animal Antimicrobials Duration of Use

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FDA posts a draft guidance with recommendations on how animal drug sponsors may voluntarily establish a defined duration of use fo...

FDA Pushing EG, DEG Testing

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Reuters says its analysis of FDA regulatory actions shows an agency crackdown on companies that fail to sufficiently test cough sy...

Guilty Plea in Adulterated HIV Meds Case

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The Justice Department says a Florida man pleaded guilty to one count of conspiracy to introduce adulterated and misbranded HIV dr...

Workshop on Dosing Pediatric Study Patients

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Federal Register notice: FDA announces an 11/30 public workshop entitled Advancing the Development of Pediatric Therapeutics (ADEP...

FDA Cut Corners to Approve Hetlioz ANDA: Vanda

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Vanda Pharmaceuticals asks the DC federal court to order FDA to vacate its corner-cutting approval of an MSN ANDA for a generic fo...

Novartis Touts Positive Lutathera Phase 3 Data

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Novartis says the Phase 3 NETTER-2 trial met its primary endpoint of improvement in progression-free survival and the key secondar...

FDA Reviewers Dismiss ALS Therapy Benefit

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FDA reviewers say clinical data submitted in a BrainStorm Cell Therapeutics BLA for Lou Gehrigs Disease treatment NurOwn do not de...

Calcipotriene ANDA Withdrawal Corrected

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Federal Register notice: FDA corrects a 6/2 notice wrongly announcing that Tomers ANDA for calcipotriene was being withdrawn.

FDA Clears Profound Medical Ablation Module

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FDA clears a Profound Medical 510(k) for the companys Thermal Boost module for use in conjunction with its Tulsa-Pro, which permit...