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Regeneron Pharmaceuticals announced FDA extended review timelines to Q4 2025 for two regulatory submissions related to Eylea HD due to a major amendment stemming from a third-party manufacturing inspection. Despite the delay, Eylea HD remains available in the U.S., and Regeneron anticipates a swift resolution as they address manufacturing concerns and continue expanding treatment options.

The collaboration will leverage Boehringer Ingelheim’s manufacturing expertise to accelerate AnGes’ HGF gene therapy toward regulatory approval and patient access.

A joint statement lays out the framework for a potential trade agreement.

The company will be heavily investing over the next decade to build a new biopharmaceutical plant in Holly Springs, NC, creating 120 jobs and reinforcing its $55 billion pledge to strengthen US manufacturing, R&D, and innovation.

Johnson & Johnson assures no impact on current treatments for multiple myeloma.

Staff members published an open letter to the HHS Secretary following a deadly shooting earlier this month.

Rob Abbott, CEO, ISPOR, highlights how uniting regulators, payers, and academic leaders worldwide can accelerate access to innovative treatments and strengthen evidence-based healthcare.

The company is downsizing its gene therapy operations following reduced demand from a major client, even as industry reliance on CDMOs and CMOs for capacity and expertise continues to grow.

Jazz Pharmaceuticals partners with Saniona to develop SAN2355, a promising epilepsy treatment, enhancing options for neurological disorders.

The clinical hold is due to questions about BX004’s nebulizer device, temporarily pausing US enrollment in the cystic fibrosis Phase IIb trial (NCT06998043) while European dosing continues.

The regulatory body determined that PTC Therapeutics’ New Drug Application for vatiquinone did not provide sufficient evidence of efficacy in patients with Friedreich’s ataxia.

The comments came after the AAP announced its vaccine recommendations, which go against those of the CDC.

The move is likely part of the company’s goal to reduce costs as it faces increased competition in the GLP-1 space.

Ron Lanton, partner, Lanton Law, warns that ongoing lawsuits targeting vaccine policy could create ripple effects across FDA decision-making and reshape how future emergency use authorizations are granted.

Ron Lanton, partner, Lanton Law, warns that recent changes to federal vaccine recommendations could trigger extensive litigation as insurers, providers, and patients face new access and coverage challenges.

Rob Abbott, CEO, ISPOR, highlights how AI is streamlining research and improving patient care while stressing the importance of human oversight.

The AAP diverges from CDC guidelines, advocating for Covid-19 vaccines in young children, igniting debate over vaccine policy and public health integrity.

The disease doesn’t have any FDA approved treatments, leaving families desperate for FDA to approve the treatment.

The global biotherapeutics company announced that it will seek to streamline operations as part of a broader transformation to boost efficiency, refocus on core businesses, and reinvest in high-priority programs.

The collaboration will explore RNA-based small molecule drug candidates aimed at neurological conditions where existing treatment options remain limited.

Monument Therapeutics partners with FNIH to advance MT1988, a promising treatment for cognitive impairment in schizophrenia, through a groundbreaking clinical trial.

Whole genome sequencing market is projected to grow significantly, driven by advancements in technology and personalized medicine, reaching $6.1 billion by 2030.

Rob Abbott, CEO, ISPOR, highlights that the United States excels in areas like cancer screening and advanced medical technology while facing challenges such as rising costs, lack of universal coverage, and health outcomes that lag behind other high-income nations.

Novo Nordisk reduces Ozempic's price to $499/month for self-paying patients, enhancing access to essential diabetes treatment and ensuring patient safety.

Tomnya is the first new fibromyalgia therapy approved by the FDA in over 15 years.

The latest decision will give Vanda the opportunity to have a hearing with FDA over the sNDA’s status.

NIH's new strategy emphasizes transparency, prioritizes urgent health needs, and shifts focus to domestic research and innovative health solutions.

Expanded approval of Wegovy was based on results from the Phase III ESSENCE trial (NCT04822181), which demonstrated significant improvements in patients with metabolic dysfunction-associated steatohepatitis and liver fibrosis compared to placebo at 72 weeks.

The report details the administration’s potential plans for a variety of issues that will directly impact pharma.

Pfizer's inclacumab fails Phase III study for sickle cell disease, disappointing the community while the company remains committed to future treatments.