Pharma News

Pfizer and Astellas Pharma announced positive topline results from a phase 3 trial of Xtandi (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-...

March is Myeloma Awareness Month, and Sikander Ailawadhi, M.D., hematologist/oncologist at Mayo Clinic Comprehensive Cancer Center, shares details about new advancements in research leading to bet...

The FDA’S Antimicrobial Drugs Advisory Committee (ADAC) voted 16 to 1 on Thursday in favorof Pfizer’s antiviral Paxlovid (nirmatrelvir and ritonavir) for the treatment of mild-to-moderate COVI...

The FDA has granted expanded approval to Novartis’ Tafinlar (dabrafenib) in combination with Novartis’ Mekinist (trametinib) for pediatric patients one year and older with low-grade glioma with...

Sponsors developing long-acting local postoperative anesthetics should consider including novel, clinically meaningful endpoints in their trial design, the FDA has said in new draft guidance. ...

Shares of Sarepta Therapeutics Inc slumped as much as 21% on Friday on uncertainty over its gene therapy for Duchenne muscular dystrophy after the U.S. health regulator reversed its decision on a p...

(Reuters) - Amgen Inc said on Thursday it would cut 450 jobs, or less than 2% of its workforce, making it the company's second round of layoffs this year amid intensifying pressure on drug prices ...

Acesion Pharma, the biotech pioneering first-in-class novel therapies for Atrial Fibrillation (AF), the most common cardiac arrhythmia, today announced positive data from its Phase 2 trial of AP306...

Formology Lab of Chatsworth, Calif., earned an FDA warning letter for failing to verify the identity of each component of a drug product, having no written procedures for process or production cont...

The slim-down at Novartis continues, with some eye disease products now reportedly on the chopping block.

Sanofi is set to acquire Provention Bio, picking up the company’s first-in-class treatment to delay stage 3 type 1 diabetes (T1D).

The FDA has granted Orphan Drug status to Ellipses Pharma’s EP0042, an investigational drug for treatment of patients with acute myeloid leukemia.