89bio Announces U.S. FDA has Granted Breakthrough Therapy Designation for Pegozafermin in Nonalcoholic Steatohepatitis (NASH)

It has the potential to meet the treatment needs for F2/3 patients as well as compensated cirrhotic (F4) patients.

FDA accepts for review Takeda’s NDA for eosinophilic esophagitis therapy

TAK-721, a new mucoadherent topically active oral viscous formulation of budesonide, is an investigational treatment for EoE. It is intended to treat the localised oesophageal inflammation caused by EoE.

Krystal Biotech Announces FDA Clearance of Investigational New Drug Application for KB408 for the Treatment of Type 1 Alpha-1 Antitrypsin Deficiency

KB408 is a modified, replication-defective, non-integrating HSV-1-derived vector carrying two full-length copies of the serpin family A member 1 (SERPINA1) gene to enable expression of alpha-1 antitrypsin (AAT).

Merck (MRK) Keytruda Cervical Cancer sBLA Gets FDA Priority Tag

The sBLA is seeking approval for Keytruda (pembrolizumab) plus concurrent chemoradiotherapy for patients with newly diagnosed high-risk locally advanced cervical cancer.

Eli Lilly Is on the Warpath, Now Suing Pharmacies and Spas for Selling Compounded Mounjaro

The Food and Drug Administration has previously warned the public to stay away from sketchy sources of the similar drug semaglutide, sold under the brand names Ozempic and Wegovy.

Travere kidney drug narrowly fails confirmatory trial following FDA approval

Travere Therapeutics said Thursday that a study meant to confirm the benefit of its newly approved drug for a rare kidney disorder narrowly failed.

We’ve made great progress’: UH scientists who created anti-fentanyl vaccine step closer to becoming FDA-approved

We are now manufacturing clinical-grade vaccines. Then, we’ll do the toxicology studies and then submit an application to the FDA to conduct phase one human clinical trials,” Haile explained.

Mesoblast Sees Path Forward for Twice-Rejected Cell Therapy After FDA Meeting

Following a Type A meeting with the FDA, Mesoblast claims it has a better understanding of what the regulator needs in order to consider approving remestemcel-L in the treatment of pediatric and adult steroid-refractory acute graft versus host disease.

Krystal Biotech Announces FDA Clearance Of IND For KB408

FDA cleared the Investigational New Drug Application (IND) for the company's orphan drug designated KB408 for the treatment of alpha-1 antitrypsin deficiency (AATD)