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.

Viridian Therapeutics partners with Kissei Pharmaceutical to advance treatments for thyroid eye disease in Japan, enhancing patient care and market potential.

Approval is based on results from the Phase III VALIANT trial (NCT05067127), in which Empaveli demonstrated a 68% reduction in proteinuria, stabilization of kidney function, and a significant reduction in C3 deposits in patients with C3 glomerulopathy or primary immune complex membranoproliferative glomerulonephritis.

Gen Li discusses when the industry can expect to start seeing technological advancements implemented.

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.

In many plants, the full expression of therapeutic value only emerges when their components are allowed to work in concert.

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.

Zura Bio’s CEO and director Robert Lisicki discusses how his path to leadership taught him the importance of building a team that can deliver even when the goals don’t seem to be achievable.

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.