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In today’s Pharmaceutical Executive Daily, we cover the FDA’s new fast-track review program for U.S.-made generics, Novartis’ FDA approval of Rhapsido for chronic spontaneous urticaria, and Halozyme’s $750 million acquisition of Elektrofi to strengthen drug delivery innovation.

Products tested and manufactured exclusively from domestic materials will be eligible for the program.

Roche's Tecentriq and lurbinectedin combo gains FDA approval, significantly improving outcomes for extensive-stage small cell lung cancer patients.

Jazz Pharmaceuticals announces FDA approval of Zepzelca and Atezolizumab for extensive-stage small cell lung cancer, enhancing treatment options and survival rates.

Stay informed on key pharmaceutical news, including tariff updates, FDA shutdown risks, and insights from recent cell and gene therapy reviews.

Takeda shifts focus from cell therapy to innovative drug candidates, aiming for transformative therapies and strategic partnerships in its pipeline.

Vanda Pharmaceuticals collaborates with the FDA to expedite reviews for Hetlioz and Tradipitant, aiming to resolve ongoing disputes and approvals.

FDA continues essential operations during the funding lapse, focusing on public health safety while halting new drug applications and submissions.

This marks the latest change in the President’s strategy.

How cell and gene therapy developers can lessen the chances of receiving FDA complete response letters through the use of proactive chemistry, manufacturing, and controls strategies.

In today’s Pharmaceutical Executive Daily, we cover Novo Nordisk’s resubmission of its BLA for Awiqli, the FDA’s approval of Kedrion’s Qivigy for primary humoral immunodeficiency, and Eli Lilly’s decision to halt development of a muscle-preserving weight-loss therapy.

Novartis gains FDA approval for Rhapsido, the first oral BTK inhibitor for Chronic Spontaneous Urticaria, offering new hope for patients.

Halozyme Therapeutics acquires Elektrofi for $750 million, enhancing drug delivery technology with Hypercon's innovative microparticle approach for biologics.

Details of the agreement are confidential, but it reportedly fulfills the requirements President Trump set forth in a July 31st letter to the company.

In today’s Pharmaceutical Executive Daily, we cover AbbVie’s new API manufacturing site in Illinois, AstraZeneca’s plan to harmonize its global stock exchange listings, and reports that President Trump will announce a government-run direct-to-patient drug purchasing website.

Kedrion Biopharma celebrates FDA approval of Qivigy, enhancing treatment options for primary immunodeficiency while committing to significant U.S. investments.

Novo Nordisk aims to revolutionize diabetes care with Awiqli, a potential once-weekly insulin, resubmitted for FDA approval after addressing previous concerns.

The move will allow stocks to be traded across the US, London, and Stockholm exchanges.

In today’s Pharmaceutical Executive Daily, we cover the impact of Novo Nordisk layoffs on its hometown in Denmark, GSK’s appointment of Luke Miels as its next CEO, and the FDA’s approval of Regeneron’s Evkeeza for children with homozygous familial hypercholesterolemia.

The news comes just days after President Trump’s announcement on 100%-pharma tariffs.

Genmab's acquisition of Merus for $8 billion enhances its oncology portfolio, promising growth and innovative therapies like Petosemtamab for cancer treatment.

GSK appoints Luke Miels as CEO designate, set to lead the company into a pivotal growth phase starting January 2026.

The FDA has expanded Johnson & Johnson’s Tremfya (guselkumab) approval to children six years and older weighing at least 40 kilograms with moderate to severe plaque psoriasis or active psoriatic arthritis, marking the first pediatric approval of an IL-23 inhibitor for these conditions.

In today’s Pharmaceutical Executive Daily, we cover the White House’s push for a Most Favored Nation drug pricing model, the FDA’s approval of Eli Lilly’s Inluriyo for ESR1-mutated metastatic breast cancer, and President Trump’s call for steep tariffs on branded pharmaceuticals.

Crinetics Pharmaceuticals celebrates FDA approval of Palsonify, the first oral treatment for acromegaly, enhancing patient care and outcomes.

Regeneron's Evkeeza gains FDA approval for treating young children with homozygous familial hypercholesterolemia, addressing a critical health need.

Companies that have broken ground or begun construction on US manufacturing sites will be exempt from these tariffs.

Most Favored Nation drug pricing proposal aims to tie US medicine costs to lower European rates, but experts warn this approach could restrict patient access to lifesaving treatments, slow innovation, and jeopardize future drug development by importing flawed foreign price-control models.

Kalundborg is home to a major Novo Nordisk factory which is likely to impacted by layoffs.

FDA approves Eli Lilly’s Inluriyo (imlunestrant) for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer that has progressed after endocrine therapy.