Pharma News, 2023

The FDA has lifted a clinical hold on Inhibikase Therapeutics’ clinical trial evaluating IkT-148009, its drug candidate for treatment of Parkinson’s disease. ...

The FDA has approved Merck’s blockbuster drug Keytruda (pembrolizumab) as a single agent for adjuvant treatment in adult patients with stage IB, II or IIIA nonsmall-cell lung cancer (NSCLC) follo...

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most sub...

Eloxx Pharmaceuticals, Inc., a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today announced that the first patients have now been enrolled in its Phase 2 study of ELX-02 fo...

The FDA granted Syros Pharmaceuticals Fast Track status for its drug candidate tamibarotene for the treatment of higher-risk myelodysplastic syndrome, a group of disorders caused by a disruption i...

The US Food and Drug Administration (FDA) has granted clearance for Neurogene’s investigational new drug (IND) application for NGN-401 to treat Rett syndrome....

Eli Lilly is leaving nothing to chance when it comes to making the most of its fast-growing diabetes therapy Mounjaro – it is investing another $450million at a facility in North Carolina that wi...

The FDA has finalized guidance on trials of human drugs containing cannabis and cannabis-derived compounds, offering updated direction on federally authorized sources for cannabis.

TheracosBio today announced that the U.S. Food and Drug Administration (FDA) has approved Brenzavvy™ (bexagliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor.  ...

Takeda will pay Hutchmed $400 million upfront to license an experimental cancer drug for use outside of China, with plans to complete a submission for U.S. approval in the first half of the year. ...

The FDA has declined to grant Accelerated Approval for donanemab — Eli Lilly’s entry into the antiamyloid antibody race — saying there isn’t enough long-term data to support such a move. ...

Cadrenal Therapeutics (Nasdaq: CVKD), a biopharmaceutical company focused on developing tecarfarin, a clinical-stage novel cardiorenal therapy with orphan drug designation, announced today that the...