Pharma News

A federal appeals court has rejected Jazz Pharmaceuticals’ attempt to overturn a lower court ruling invalidating a patent claim covering the company’s Risk Evaluation and Mitigation Strategies...

Confo biotech hopes that CFTX-1554 can address pain without causing side effects common with opioids and other pain meds, such as addiction and sedation. ...

The FDA has granted a Qualified Infectious Disease Product (QIDP) designation to ForCast Orthopedics’ FC001 antibiotic candidate to treat patients with periprosthetic joint infection, a rare com...

The FDA will soon announce a new pilot program to help developers of gene therapies for rare diseases get their treatments approved faster, said Peter Marks, director of the FDA’s Center for Biologi...

Reata Pharmaceuticals is aiming to make the drug omaveloxolone available by the second quarter of 2023.

The FDA outlined drug trial options for developers of neovascular age-related macular degeneration drugs in a newly published draf

t guidance.

The U.S. Food and Drug Administration has accepted for Priority Review SpringWorks Therapeutics’ New Drug Application for nirogacestat, an investigational gamma secretase inhibitor, for the treat...

More generic products will soon join the fold at Dr. Reddy’s Laboratories as the drugmaker has agreed to spend up to $105 million to purchase Mayne Pharma’s U.S. copycats portfolio. ...

The FDA has approved Sanofi and Sobi’s Altuviiio for adults and children with Hemophilia A, for use in prophylaxis, perioperative management during surgery and on-demand treatment to control blee...

As legislation in multiple states eases former restrictions around medical and recreational cannabis in the United States, an increasing proportion of the population reports use of the drug. Betwe...

The Food and Drug Administration (FDA) has created a task force to fast track and streamline the approval and evaluation of COVID-19 drug

s in the country.

Donanemab, Eli Lilly and Company’s investigational antibody therapy for Alzheimer's disease (AD), has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA).&nbs...