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Celltrion's Avtozma IV gains FDA approval for treating cytokine release syndrome, enhancing treatment options for patients aged 2 and older.

Ajovy becomes the first-and-only calcitonin gene-related peptide agonist approved for pediatric patients aged six to 17 years with episodic migraine who weigh at least 99 lbs.

The deal brings the FDA-approved neuroblastoma therapy Danyelza (naxitamab-gqgk) to SERB Pharmaceuticals and advances its expansion in rare and pediatric oncology.

The move comes amidst a turbulent time at HHS.

The Regeneron litigation highlights that donations routed through independent entities are not immune from challenge, especially if the government believes they are effectively covering a patient’s co-pay for a specific product.

Explore how Wounded Warrior Project and advocates like Morgan Fox promote mental health awareness and support for veterans facing PTSD and depression.

The choice reflects the company's aims to revolutionize chronic care and expand global health solutions through innovative technology.

Gene Mack, CEO, GAIN Therapeutics, highlights early Phase Ib data showing GT-02287 may enhance neuroprotection across a wider spectrum of Parkinson’s patients regardless of genetic status.

The AI-driven collaboration will use Syntekabio’s DeepMatcher platform to identify new therapeutic targets for MetaVia’s DA-1241 following promising Phase IIa trial (NCT06054815) results in patients with presumed metabolic dysfunction-associated steatohepatitis.

Company opts not to advance VX-993 into pivotal development after Phase II data show no statistically significant benefit over placebo in post-bunionectomy surgical pain relief.

The supplemental New Drug Application is supported by data from the Phase II TRANSCEND FL trial (NCT04245839), which showed that patients treated with Breyanzi for relapsed or refractory marginal zone lymphoma demonstrated strong and lasting responses.

A Harvard Business School Healthcare Alumni Association Q&A with Stephanie J. Creary, Assistant Professor of Management at The Wharton School of The University of Pennsylvania.

Despite missing the primary endpoint, SB-01 demonstrated durable clinical improvements and consistent results in the Phase III MODEL trial (NCT05516992), reinforcing its potential as a non-surgical treatment for chronic low back pain associated with degenerative disc disease.

Following the discontinuation of ALLO-647 due to a treatment-related death, Allogene will move forward with a streamlined outpatient regimen aimed at accelerating enrollment and regulatory review in the Phase II ALPHA3 trial (NCT06500273).

Gene Mack, CEO, GAIN Therapeutics, outlines how early trial results for GT-02287 are shaping the company’s strategy for advancing a potential new treatment for Parkinson’s disease.

Organizations commonly navigate outdated systems that make collaboration harder and breakthroughs slower, causing delays, missed insights, and costly rework.

Gene Mack, CEO, GAIN Therapeutics, shares how growing clinician confidence and strong early experiences helped accelerate enrollment in the company’s Phase Ib Parkinson’s disease trial.

Members of the industry believe the US should remain an innovation-friendly market.

FDA mandates new opioid labeling to highlight long-term risks, aiming to combat addiction and improve patient safety in pain management.

Facing patent expiration for its blockbuster Keytruda, Merck aims to streamline operations with significant job cuts and continued R&D investments.

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.

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.