Pharma News, 2023

The FDA has granted Fast Track designation to Regenxbio’s RGX-202 candidate as a potential one-time gene therapy treatment for Duchenne muscular dystrophy.

The FDA has accepted for review a supplemental biologics license application for pembrolizumab plus fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with...

When former U.S. Food and Drug Administration (FDA) commissioner Dr. Jane Henney approved the abortion pill mifepristone in 2000, she knew the decision was an important one for women’s health. It...

The next-generation of anti- amyloid beta therapeutics could be advanced by Biogen exercising the option to develop Denali’s antibody programme.

Sumitomo Pharma Oncology has received FDA’s Orphan Drug designation for its TP-1287 candidate to treat Ewing sarcoma, a rare cancer that typically occurs in children or teenagers. ...

The deal to develop a new class of disease-modifying treatments for diabetes could be worth up to $2.6bn.

On March 22, 2023, at the request of the U.S. Food and Drug Administration, Ascend Laboratories LLC. issued a voluntary nationwide recall of certain lots of Dabigatran Etexilate Capsules, a blood ...

Pfizer CEO Albert Bourla and dozens of other biotech and pharmaceutical company leaders have signed an open letter in support of the US Food and Drug Administration’s authority “to approve and ...

Idorsia Pharmaceuticals has petitioned the Drug Enforcement Administration (DEA) to deschedule dual orexin receptor antagonists (DORA), a class of chronic insomnia medications. ...

Administration (FDA) plans to hold a meeting of its outside experts in June to discuss full approval of the Alzheimer's drug developed by Eisai Co Ltd 4523.T and Biogen Inc BIIB.O, according to a f...

The companies’ decision is based on the recommendation from an independent data monitoring committee (DMC).

BioNTech and China-based Duality Biologics have inked a licensing and collaboration deal to develop two antibody-drug conjugates (ADCs).