Pharmaceutical

FDA accepts resubmission of Ardelyx’s NDA for XPHOZAH

The resubmitted NDA is based on a comprehensive development programme that inclu...

LAPIX receives US patent for LPX-TI641 to treat autoimm...

LPX-TI641 is being developed to treat neuro-autoimmune indications including mul...

Forbion European Acquisition and enGene sign merger deal

The combined company will be named enGene Holdings on completion of the deal.

Lumen Bioscience’s LMN-201 secures FDA fast track statu...

LMN-201 is given concomitantly with standard antibiotics and eight weeks thereaf...

Elevar submits new drug application for uHCC combo therapy

Rivoceranib is an oral TKI, while camrelizumab is a PD-1 inhibitor.

Parliamentarians call on G7 leaders to invest in neglec...

Leaders must renew their commitment to eradicating NTDs if they are to achieve t...

EMA issues guidance amidst European medicine shortage

Whilst medicine shortages are a global health problem, European countries are be...

Gate Neurosciences plans Phase II MDD trial with next-g...

The company aims to start the Phase II study of its lead compound zelquistinel i...

STAT+: FTC widens probe into pharmacy benefit managers ...

The Federal Trade Commission is widening its probe into PBMs and their impact on...

Senators probing largest Medicare Advantage plans over ...

Senators warned the country’s largest Medicare Advantage insurers that they cann...

Study: Giving an antibiotic to household contacts of pe...

In a new trial, providing contacts of people with leprosy with a single dose of ...

STAT+: House panel takes first steps toward reining in ...

A House panel took its first steps toward reining in how hospitals are paid and ...

Federal judges question FDA authority in abortion pill ...

Federal judges questioned the FDA's authority during an appeals court hearing ov...

STAT+: Could an upcoming Supreme Court case make the FD...

The FDA could take longer to write regulations and make decisions if the Supreme...

STAT+: CVS Health to close clinical trial unit two year...

CVS first revealed its clinical trials unit in May 2021, which had a focus on dr...

STAT+: Pharmalittle: FTC suit over Amgen spotlights ‘bu...

The FTC's suit to block Amgen from acquiring Horizon Therapeutics cast a spotlig...