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What Does the FDA's Priority Review Mean for Savara's MOLBREEVI

5 months ago

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

5 months ago

What Does the FDA Warning Mean for Medline's Operations

4 months ago

What Does Teva's Recent FDA Acceptance Mean for Investors

5 months ago

What Does the FDA's BLA Acceptance Mean for Inhibrx

2 months ago

Savara: High Potential Binary Bet Cruising To PDUFA After 3 Month Speed Bump

Savara Inc. (SVRA) faces a pivotal near-term catalyst as its APAP BLA PDUFA approaches, following a 3-month delay. Clinical and regulatory milestones remain key investment drivers, with the upcoming d...

SVRA

Stock News•1 months ago

Palvella Therapeutics Submits First Module of Rolling New Drug Application to FDA for QTORIN™ Rapamycin for the Treatment of Microcystic Lymphatic Malformations

Palvella Therapeutics submitted the first module of a rolling NDA to the FDA for QTORIN™ rapamycin to treat Microcystic Lymphatic Malformations, which could expedite the review timeline.

PVLA

Stock News•2 months ago

Press Release: Sanofi's venglustat accepted for priority review in the US to treat type 3 Gaucher disease

The FDA granted priority review to Sanofi’s new drug application for venglustat, an investigational oral treatment for type 3 Gaucher disease. This designation accelerates the regulatory timeline for ...

SNY

Stock News•3 months ago

aTyr Pharma Announces First Quarter 2026 Results and Provides Corporate Update

aTyr Pharma will advance efzofitimod development for pulmonary sarcoidosis following a constructive Type C meeting with the FDA. The company plans to submit an IND in June 2026 to initiate a Phase 3 s...

ATYR