Pharma News, 2023

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...

The European Commission has granted a conditional marketing authorization for CSL’s Hemgenix (etranacogene dezaparvovec) as the first EU-approved gene therapy for treatment of  Hemophilia B....

Theravance Biopharma and Viatris have alleged that multiple drugmakers infringed on their patent protections for Yupelri (revefenacin) — a long-acting bronchodilator used to treat chronic obstru...

The FDA approved deutetrabenazine extended-release tablets (Austedo XR, Teva Pharmaceuticals) for adults with tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD). ...

Cognition Therapeutics, Inc. (NASDAQ: CGTX) announced that it has cleared the U.S. Food and Drug Administration comment period and may now proceed with the 540-patient Phase 2 START study of CT1812...

The FDA has approved Apellis Pharmaceuticals’ Syfovre (pegcetacoplan) injection as the first approved therapy to treat geographic atrophy secondary to age-related macular degeneration, a leading ...

Merck’s Lagevrio (molnupiravir) has not demonstrated a statistically significant reduction in the risk of COVID-19 infection after household exposure to another person who has COVID-19. ...

Modus Therapeutics AB , a company developing innovative treatments for patients with major unmet medical needs, announces positive top-line data from its Phase 1b lipopolysaccharide (LPS) provocati...

Patients with the ultra-rare rare disease CHAPLE could have a first approved treatment in the summer, now that the FDA has started its review of Regeneron’s dug candidate pozelimab. ...

The FDA has accepted for review two supplemental new drug applications (sNDAs) for Merck’s Prevymis (letermovir) for use with adult kidney transplant and stem cell transplant patients. ...

Multiple drugmakers have filed amicus briefs to the U.S. Supreme Court refuting a broad patent claim by Amgen that — if upheld — could have sweeping implications in drug development. ...