Regulatory

Positive feedback was based on Phase III AQUILA trial results, which showed a significant clinical benefit with Darzalex Faspro in patients with high-risk smoldering multiple myeloma.

Previously granted Emergency Use Authorization, Nuvaxovid is now available for individuals over 12 years of age.

Zynyz is the first and only FDA-approved first-line treatment for adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal.

Welireg marks the first FDA-approved non-surgical treatment option for locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma in patients over 12 years of age.

Emrelis is the first FDA-approved treatment for previously treated patients with locally advanced or metastatic non-squamous non-small cell lung cancer with high c-Met protein overexpression.

The organization believes that the proposed cuts will be harmful to Americans suffering from mental illnesses.

The decision follows ongoing investigations into serious adverse events primarily reported in elderly individuals who received the Ixchiq chikungunya vaccine.

Groups like PhRMA and the HDA issued statements explaining their stance of the drug-pricing policy.

The order pushes drug companies to reduce drug prices in the United States to fall in line with other countries around the world.

The President plans to sign an executive order on Monday morning to enforce the trade clause.

Proposed cuts to Medicaid could cause serious issues in rural areas of the United States.

Navigating technology and regulatory shifts in pharma revenue management.

The Avmapki Fakzynja Co-Pack marks the first FDA-approved treatment for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who have received prior systemic therapy.

Commissioner Markary announced the plans alongside the results of a generative AI pilot for scientific reviewers.

Pharma companies have opportunities to grow, but they also must plan for a complicated future.

The Refusal to File letter comes despite the FDA’s prior encouragement to submit a supplemental biologics license application for Anktiva in patients with BCG-unresponsive non-muscle invasive bladder cancer with papillary disease.

In the face of potential tariffs, the pharmaceutical industry must find alternative ways to reduce costs.

Selarsdi, a biosimilar to Stelara, is approved for adult and pediatric psoriatic arthritis, plaque psoriasis, Crohn disease, and ulcerative colitis.

The investigation would determine whether excessive imports pose a threat to national security.

AbbVie secures FDA approval for Rinvoq as the first oral Janus kinase inhibitor indicated for giant cell arteritis, expanding its immunology portfolio and signaling strategic growth opportunities in underserved autoimmune markets.

IQVIA’s Doug Long offers a lay of the land, including trends and developing issues that are shaping the current market.

Approval of penpulimab-kcqx marks the company’s US regulatory debut and introduces a new immunotherapy option for advanced nasopharyngeal carcinoma.

The chaotic tariff situation is forcing pharma companies to prepare for multiple outcomes.

The submission is backed by clinical data from over 2,100 patients, including two pivotal Phase III trials in patients treated with trenibotulinumtoxinE for moderate to severe glabellar lines.

The simplified requirements for Camzyos are expected to ease prior contraindications, thereby simplifying treatment and expanding eligibility in patients with symptomatic New York Heart Association Class II-III obstructive hypertrophic cardiomyopathy.

Dupixent is the first new targeted therapy to receive FDA-approval for chronic spontaneous urticaria in adults and adolescents over 12 years of age in over a decade.

Regulatory action was based on data from the Phase III QUASAR trial, which demonstrated that Eylea HD dosed every eight weeks achieved non-inferior visual acuity outcomes compared to Eylea in patients with macular edema following retinal vein occlusion.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted to expand access to Pfizer’s respiratory syncytial virus vaccine Abrysvo for high-risk adults in their 50s and voted in favor of GSK’s meningococcal vaccine, Penmenvy, for streamlined adolescent protection.

Four tips for midsized companies when entering new global markets.

Sonam Dubey, a partner at Beghou Consulting, discusses the potential impact of a possible ban on direct-to-consumer advertising amid policy and government agency overhauls in the US.