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FDA Announces New Plausible Mechanism PathwayLatest Content

Pharmaceutical Executive Daily: Dr. Richard Pazdur Appointed as Director CDER

FDA Announces New Plausible Mechanism Pathway

WeightWatchers to Offer Novo Nordisk’s Oral Wegovy, if Approved Next Year

Roundup: Ovid Therapeutics and Metagenomi Announce 2025 Third Quarter Results and Leadership Updates

Bristol Myers Squibb Expands its Strategic Collaboration with Sarah Cannon Research Institute

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Following the removal of George Tidmarsh, HHS and FDA has appointed Richard Pazdur, M.D., director of CDER.

How the Metsera deal extends Pfizer’s 25-year blueprint for growth.

In today’s Pharmaceutical Executive Daily, we report on new data showing Wegovy’s potential to reduce liver injury in patients with MASH, Eli Lilly’s latest strategic collaborations in gene therapy, and Novo Nordisk’s decision not to increase its acquisition offer for Metsera following Pfizer’s entry.

The stock increased after positive Q3 earnings and deals with the Trump administration.

The Swiss region hopes to attract pharma companies looking to escape uncertainty in the US market.

Per the FDA's request, HHS is updating hormone therapy labels, removing misleading warnings to empower women in managing menopause and improving their health options.

Novo Nordisk presented the findings at the AASLD 76th annual meeting.

In today’s Pharmaceutical Executive Daily, we cover the FDA’s approval of Darzalex Faspro for adults with high-risk smoldering multiple myeloma, the industry’s growing interest in direct-to-patient wholesale models, and the FDA’s expansion of its National Priority Voucher program to accelerate review of critical therapies.

Eli Lilly is partnering with MeiraGTx to develop and commercialize ophthalmology gene therapies, and with SanegeneBio to advance RNAi-based treatments for metabolic diseases, with the agreements collectively valued at more than $1.6 billion in potential milestone payments.

Launching next year, the new CMS Innovation Center initiative—known as the GENEROUS Model—aims to align Medicaid drug prices with global standards, reduce prescription spending, and strengthen the program’s long-term sustainability through fairer state purchasing and transparent pricing rules.

Metsera finalizes a $10 billion merger with Pfizer after rejecting Novo Nordisk's bids amid legal concerns to ensure shareholder value and regulatory safety.

In today’s Pharmaceutical Executive Daily, we cover Eli Lilly and Novo Nordisk’s plans to bring their leading weight-loss medications to the TrumpRx platform, the State of Texas’ legal move to block Kenvue’s dividend payment, and the FDA approval of Darzalex Faspro for adults with high-risk smoldering multiple myeloma.

The FDA has added six new therapies to its Commissioner’s National Priority Voucher program, bringing the total to 15 products that address major public health needs, including obesity, cancer, sickle cell disease, and drug-resistant tuberculosis.

Johnson & Johnson secures FDA approval for Darzalex Faspro as the first and only treatment for adults with high-risk smoldering multiple myeloma, supported by Phase III Aquila trial data showing a 51% reduction in disease progression or death.

As leading drugmakers launch direct-to-patient platforms with steep discounts and digital care bundles, a new channel dynamic is emerging that gives manufacturers greater control of patient engagement while redefining, but not replacing, the strategic role of traditional wholesalers.






















