Applied Therapeutics says it received FDA's warning letter for genetic disease drug study
Applied Therapeutics said on Monday it received a warning letter limited to a trial studying its genetic disease drug, after ...
MedPage Today2d
Florida's Canadian Drug Import Plan Goes Nowhere After FDA Approval
Colorado and Florida are among at least nine states that have passed laws allowing for Canadian drug importation. Colorado's ...
WebMD23h
FDA Approves New SVT Drug for Critical Care Use
The FDA has approved Rapiblyk, a new drug to treat irregular heartbeats in critically ill hospitalized patients with severe ...
GlobalData on MSN10h
J&J’s sBLAs seek FDA approval of TREMFYA for paediatric conditions
The submission for treating paediatric plaque psoriasis is supported by outcomes from the Phase III PROTOSTAR study in ...
Heath Headlines: New drug treating food allergies gets FDA approval
Four million people are unable to tolerate one of the most common food allergies in the U.S. The allergy typically lasts a ...
FierceBiotech1d
FDA rejects Applied filing for rare disease approval on clinical grounds, sinking stock
The FDA has rejected Applied Therapeutics’ attempt to win approval on the strength of a failed phase 3 trial, triggering a 75 ...
BioSpace1d
FDA’s Accelerated Approval Pathway Drives Momentum for Intractable, Fatal Diseases
Despite hotly debated biomarkers and failed or delayed confirmatory trials, the accelerated approval program has a track ...
Gland Pharma secures US FDA approval for Glaucoma treatment
Gland Pharma receives USFDA approval for Latanoprost Ophthalmic Solution, strengthening its position in the US pharmaceutical ...
US FDA declines to approve Applied Therapeutics' genetic disease drug
Applied Therapeutics said on Wednesday that the U.S. FDA declined to approve its drug to treat galactosemia, a rare genetic ...
BioSpace4h
Intra-Cellular Eyes Depression Approval for Caplyta as Stock Soars Under the Radar
Intra-Cellular submitted its application to the FDA for Caplyta’s approval in major depressive disorder, potentially opening ...
India Infoline2d
Biocon Secures FDA Approval for Innovative Autoimmune Drug YESINTEK
Collaboration with Janssen aims to fast-track the launch and enhance accessibility to YESINTEK for patients in need.
Drug acoramidis to treat rare heart disease approved by FDA
The U.S. Food and Drug Administration has approved a drug developed at Stanford Medicine that offers hope to people diagnosed ...