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The updated label no longer requires Leqvio (inclisiran) to be used in combination with statins for low-density lipoprotein cholesterol management.

Regeneron has received a second complete response letter from the FDA for odronextamab and anticipates delays for Eylea HD due to inspection findings at a Novo Nordisk-owned manufacturing site, despite continued strong revenue growth and pipeline momentum.

Sources also say that the administration plans to split CBER in two, with one of the section focused entirely on vaccines.

The 15% tariff on pharmaceutical imports from the European Union is not a short term inconvenience, it represents a structural shift in the economics of the US pharmaceutical market.

Biotech firm aims to streamline operations and reinvest in high-growth areas such as oncology and rare diseases as it targets $1.5 billion in savings by 2027.

The actor was diagnosed with the disease at 46-years-old.

Eli Lilly's Mounjaro shows significant cardiovascular benefits in a major trial enhancing treatment options for type 2 diabetes patients.

A monthly roundup of business and people news in the pharmaceutical industry.

The letter states that the companies have 60 days to meet the President's requirements.

Aetna enhances user experience with AI-driven Care Paths, simplifying health navigation and personalizing care for members and providers alike.

The results showed that people started mirroring the eating habits of GLP-1 users even when they weren’t taking the medication themselves.

The transaction brings larsucosterol, an investigational treatment for alcoholic hepatitis, under Bausch Health’s portfolio as the company advances its liver disease research and development efforts.

Following a complete response letter rejecting accelerated approval for RP1 in advanced melanoma, IGNYTE trial investigators are urging the FDA to reevaluate the therapy’s robust survival data, just as agency leadership changes raise new questions.

The FDA’s top vaccine and gene therapy official resigned amid heightened scrutiny over recent drug approval decisions and safety concerns surrounding gene therapies.

Madrigal Pharmaceuticals secures global rights to SYH2086, aiming to enhance MASH treatment with innovative combination therapies for better patient outcomes.

The survey reveals how financial anxiety has become an everyday occurrence affecting everyday health through stress, relationship strain, and lack of sleep.

GSK sponsors the 2025 National Senior Games to raise awareness about RSV risks and prevention for older adults through education and athlete stories.

Vinay Prasad, MD, MPH, departs FDA's Center for Biologics, citing family time and avoiding distraction.

Neha Anand, Analyst, Biopharma Intelligence Services, Citeline, explains how positive Phase III results for Emrelis may position AbbVie as a key player in MET-high non-small cell lung cancer, expanding its presence in precision oncology and antibody-drug conjugates.

Current Novo Nordisk executive vice president of internal operations is named new president and CEO.

The gene therapy will resume shipments for patients who are ambulatory.

The newly formed biotech launches with five promising autoimmune candidates, $300 million in funding, and leadership from industry veterans.

The pact introduces a 15% levy on most EU exports, including pharmaceuticals.

The restructuring includes the elimination of certain roles and a reduction in the company’s global real estate footprint.

The extended review for Elinzanetant is supported by data from the Phase III OASIS 1, 2, and 3 trials, which supported the drug’s efficacy in the treatment of moderate to severe vasomotor symptoms due to menopause.

AI influencers represent the cutting edge of digital storytelling. But when applied to pharmaceutical marketing, innovation must be balanced with integrity.

The Anywhere platform will be available to a wider network of providers and patients.

Boehringer Ingelheim partners with Re-Vana Therapeutics to innovate long-acting eye disease treatments, enhancing patient care and compliance.