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FDA Presses Delay Button For Applied Therapeutics' First Potential Marketed Drug For Rare Disease - Applied Therapeutics (NASDAQ:APLT)

FDA extends the review period for Applied Therapeutics' NDA for govorestat, targeting Classic Galactosemia treatment. The new action date is set for November 28, 2024. Applied Therapeutics anticipates a decision from EMA in Q4 2024.

Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia

NEW YORK, March 28, 2024 -- Applied Therapeutics, Inc. , a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications...

Applied Therapeutics Inc. (APLT) Provides FDA Update on PDUFA Date for Govorestat

Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia

Major projects possibly coming to Yuma County

Yuma County received seven Major Amendment requests, which doesn't happen every year.

SpringWorks Therapeutics Announces PDUFA Date Extension for Nirogacestat NDA

FDA Extending PDUFA Date by Three Months to Allow More Time to Complete Their Review; New PDUFA Date Set to November 27, 2023STAMFORD, Conn., June 05, 2023 -- SpringWorks Therapeutics, Inc. , a... | June 5, 2023

SpringWorks Therapeutics Inc. (SWTX) Announces PDUFA Date Extension for Nirogacestat NDA

BioMarin Announces Record Breaking First Quarter 2023 Results, Including 15% Year-over-year Growth of Total Revenues

Growth of VOXZOGO® Accelerated with Rapid Uptake in Japan and Brazil Resulting in Increased Full-year 2023 GuidanceFull-year 2023 Top-line and Bot...

BioMarin Provides Update on FDA Review of ROCTAVIAN™ (Valoctocogene Roxaparvovec) Gene Therapy for Adults with Severe Hemophilia A

/PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today...

Manipur doctors to go ahead with OPD shutdown protest

The All Manipur Health Services Doctors’ Association (AMHSDA) on January 5 announced shutdown of OPD services in all the government hospitals from January 9 followed by indefinite shutdown in connection with its demands.