Regulatory

Delivered as a once-daily 30 mg/mL IV bolus injection over 15 seconds, Xifyrm can be used alone or alongside non-NSAID analgesics as part of a multimodal pain strategy.

Regulatory action was based on data from the Phase III IMforte trial, which showed that Zepzelca plus Tecentriq significantly extended both progression-free survival and overall survival in patients with extensive-stage small cell lung cancer.

Approval of Enflonsia was based on data from the Phase IIb/III CLEVER trial, which showed a 60.5% reduction in medically attended lower respiratory infections and an 84.3% reduction in respiratory syncytial virus-related hospitalizations.

Widaplik marks the first and only FDA-approved triple combination medication that can be used as an initial therapy for patients with hypertension who require multiple drugs to reach their blood pressure reduction goals.

FDA concluded that AXS-14’s New Drug Application was not sufficiently complete for substantive review, citing concerns with one of two clinical trials in fibromyalgia patients.

Approval was based on results from the Phase III ARANOTE trial, in which Nubeqa demonstrated a 46% reduction in the risk of radiographic progression or death when combined with androgen deprivation therapy, in patients with metastatic castration-sensitive prostate cancer.

New drug application submission was based on positive data from the Phase III GLISTEN trial, which demonstrated significant and sustained reductions in pruritus and related sleep disruption in patients treated with linerixibat.

The industry is facing challenges from the new administration that could have serious impacts on everything from market access, pricing, and supply chains.

Approval was based on data from the Phase III NextCOVE trial, which demonstrated that mNEXSPIKE met non-inferiority criteria compared to the original Spikevax as a vaccine for COVID-19.

The biopharmaceutical sector is underpinned by a unique ecosystem that combines public funding for basic research, university-led translational science, technology transfers, venture capital funding, partnerships with larger companies, and a relatively transparent and responsive regulatory system.

Approval of Nucala marks the first biologic approved for chronic obstructive pulmonary disease patients with blood eosinophil counts as low as ≥150 cells/μL.

Approval of Susvimo marks the first continuous delivery therapy indicated for diabetic retinopathy.

Clearance of ASC50 paves the way for a Phase I trial in patients with mild-to-moderate plaque psoriasis.

In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.

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.