Pharma News

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.

  Satellos Bioscience Inc. , a drug discovery company developing small molecule therapeutics to regenerate muscle as  a new approach to treating disease conditions from muscular dys...

The FDA has decided the postpandemic fate of 72 final guidances published over the past three years to address COVID-19 issues, choosing to withdraw about one-third, phase out another one-third and...

A federal judge in Florida has awarded Gilead Sciences $175.2 million in damages over charges that the defendants fraudulently enrolled individuals in Gilead’s Medication Assistance Program then ...

The US Food and Drug Administration (FDA) has granted approval for Acadia Pharmaceuticals’ Daybue (trofinetide) to treat Rett syndrome in adult and paediatric patients aged two years and above. ...

Eli Lilly’s antiamyloid antibody solanezumab struck out in a highly anticipated phase 3 preclinical treatment study, failing to alter disease progression in people who had amyloid brain plaques b...

The FDA has approved Pfizer’s Zavzpret (zavegepant), a nasal spray for acute treatment of adults with migraine, with or without aura.

The FDA had reservations about the efficacy of Roche’s Polivy as a first-line regimen alongside chemotherapy for diffuse large B-cell lymphoma (DLBCL), but its advisors feel the data is strong e...

InnoCare Pharma, a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the first subject has been dosed in clinical trial of the Com...