Major Amendment News Today

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.

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...

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

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

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

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

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.

People visiting OPD were left with little or no choice as service came to a halt in hospitals.

The All Manipur Health Services Doctors’ Association (AMHSDA) decided on a two-day OPD shutdown followed by indefinite shutdown from January 9 onwards.

All Manipur Health Services Doctors’ Association (AMHSDA) declared to impose a two-day OPD shutdown followed by indefinite shutdown from January 9 onwards.