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What Does the FDA's PDUFA Extension Signal for Rhythm Pharmaceuticals

5 months ago

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Is Rhythm Pharmaceuticals Poised for a Breakthrough in Hypothalamic Obesity

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What's Driving Rocket Pharmaceuticals' Latest FDA Review for KRESLADI

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2 months ago

BridgeBio Announces FDA Acceptance of NDA for Encaleret for ADH1

BridgeBio's NDA for encaleret in ADH1 was accepted by the FDA, with a PDUFA date of May 8, 2027. If approved, it would be the first therapy specifically for ADH1, representing a potential blockbuster ...

BBIO

Stock News•1 months ago

Praxis Precision Medicines Announces Extension Period for Relutrigine for Treatment of SCN2A and SCN8A Developmental and Epileptic Encephalopathies

FDA extended Praxis Precision Medicines' relutrigine NDA review by three months to December 27, 2026, after the company submitted additional sensitivity analyses deemed a major amendment.

PRAX

Stock News•2 months ago

Rhythm Pharmaceuticals to Announce Interim Six-Month Phase 2 Results Evaluating Setmelanotide in Patients with Prader-Willi Syndrome

Rhythm Pharmaceuticals will host a webcast on June 13 to discuss interim six-month Phase 2 results for setmelanotide in Prader-Willi syndrome, a key catalyst for the drug's potential label expansion.

RYTM

Stock News•3 months ago

Will the Label Expansion of Asceniv Boost ADMA's Top-Line Growth?

ADMA Biologics shares are in focus after the FDA expanded the label for Asceniv to include younger patients. This regulatory approval broadens the drug's addressable market and strengthens the company...

ADMA