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The FDA in February formally declared the end of the semaglutide shortage, which Novo Nordisk expects will help improve the market position of Wegovy. But Eli Lilly’s Zepbound is quickly gaining ground, with sales just $300 million behind Wegovy in Q1.

MassBio’s new report outlines several concerns, including NIH cuts undermining the research engine, FDA reductions delaying innovation and trade barriers disrupting supply chains.

Imports of pharmaceutical products surged in March, most of which came from Ireland, historically one of the biggest exporters of medicines to the U.S.

A new executive order aims to smooth the path for getting U.S. manufacturing facilities up and running; HHS says it will require placebo-controlled trials for all vaccine approvals; tariff threats hit BioNTech; Novo Nordisk’s FDA application for an oral version of Wegovy is accepted; and more.

Keytruda is set to lose exclusivity in 2028, meaning Summit may face competition from cheaper biosimilars. Meanwhile, other branded drugmakers are also seeking to improve on the blockbuster checkpoint inhibitor.

M&A and IPOs got off to a quick start in 2025 only to crash into a wall of policy challenges. Upfront payment for licensing transactions, however, grew as pharmas looked for less-risky deals.

The oncologist and former University of California, San Francisco, professor has long been critical of COVID-19 mandates and the accelerated approval of cancer drugs.

A new executive order from President Donald Trump aims to cut down the 5-to-10-year timeline to build new facilities while stepping up the rigor of inspections on foreign plants.

Biopharma venture capital fundraising declined from $8.1 billion in the first quarter of 2024 to $6.5 billion in the first three months of this year, headlined by a clutch of massive funding rounds.

The Alchemab deal will further strengthen Lilly’s early-stage pipeline for amyotrophic lateral sclerosis, coming less than a year after the pharma licensed QurAlis’ antisense oligonucleotide to correct a specific protein alteration in ALS.

In light of President Donald Trump’s impending pharma tariffs, several big companies have made massive manufacturing investments in the U.S., including Eli Lilly, Johnson & Johnson and Novartis. BMS is the latest to make a multibillion-dollar push.

Twenty attorneys general allege that the recent workforce reduction at the Department of Health and Human Services is unlawful and could have potentially irreversible consequences.

66.6% of OST-HER2 treated patients achieved 2-year overall survival compared with 40% in the historical control group (p = 0.0046) FDA issues Biologics Licensing Application (BLA) number for OST-HER2 in preparation for anticipated BLA filing for the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma following August 27, 2025 End of Phase 2 Meeting Company responds to FDA correspondences seeking to align approval metrics for Regenerative Medicine Advanced Therapy (RMAT) designation, Breakthrough Therapy designation (BTD) and Biologics Licensing Application via Accelerated Approval Program Company’s NYSE American listing included in the Russell Microcap, Russell Microcap Value and Russell Microcap Growth indexes

MHRA seeks to harmonize UK & US regulatory review via Project Orbis EMA Rapporteur Scientific Advice Meeting scheduled for October 2025

Investment accelerates Maxwell’s path toward FDA trials and global market readiness