A D.C. drugmaker has been dealt a major setback in its long-running bid to bring its treatment for a chronic gastrointestinal ...

Following an investigational new drug application clearance from the FDA, a phase 1 trial plans to evaluate CD-001.

After pushing back the decision date for Applied Therapeutics’ metabolic disorder drug govorestat, the FDA has now decided ...

Applied Therapeutics shares jumped in premarket trading after the company said that its new drug application will proceed with a priority review with regulators without other delays. Shares traded ...

Japan's MHLW has accepted for review GSK's NDA for Blenrep for patients with relapsed or refractory multiple myeloma.

In the past 60 days, estimates for Krystal Biotech’s 2024 EPS have increased from $2.09 to $2.38. The consensus estimate for 2025 earnings has improved from $4.33 to $7.31. Year to date, shares of ...

Granting patents to US firm Gilead Sciences for lenacapavir could hinder global efforts to end AIDS & restrict access to ...

Targeting two receptors instead of the one targeted by fezolinetant, the new elinzanetant did not show the liver safety ...

IPF is a rare progressive fibrosing interstitial lung disease with symptoms that include breathing difficulty, dry and persistent cough, chest discomfort and fatigue. The randomized, double-blind, ...

Lenacapavir, a very expensive drug, is not available in India and many other countries. If the Indian Patent Office clears ...

Update on FDA's Applied Therapeutics, Inc. decision to remove advisory panel for govorestat review in treating galactosemia.

New Delhi: Indian public health campaigners on Wednesday said they will oppose the patent applications of a promising new but ...