News & Updates

MIAMI, FL — The FGC2.3: Feline Vocalization Classification and Cat Translation Project, authored by Dr. Vladislav Reznikov, has crossed a critical scientific milestone — surpassing 14,000 reads on ResearchGate and rapidly climbing toward record-setting levels in the field of animal communication and artificial intelligence. This pioneering work aims to develop the world’s first scientifically grounded…

EU, China, and more are now in the crosshairs. How’s next? It’s time to act. The Trump administration has announced sweeping tariff hikes, as high as 50%, on imports from the European Union, China, and other major markets. Affected industries? Pharmaceuticals, Biotech, Medical Devices, IVD, and Food Supplements — core sectors now facing crippling costs,…

This study presents the GDP Matrix by Dr. Vlad Reznikov, a bubble chart designed to clarify the complex relationships between GDP, PPP, and population data by categorizing countries into four quadrants—ROCKSTARS, HONEYBEES, MAVERICKS, and UNDERDOGS depending on National Regulatory Authorities (NRAs) Maturity Level (ML) of the regulatory affairs requirements for healthcare products. Find more details…

PRIME eligibility requests: 2026 deadlines for submission and timetable for assessment

As Novo Nordisk cuts 9,000 people from its organization in a restructuring effort, BioSpace looks back on the Danish pharma company’s rise.

These 27 markets, comprising countries across Asia, Europe and South America, together contributed some 12% of Lundbeck’s earnings in 2024.

EMA’s Management Board has unanimously approved the renewal of the mandate of the Agency’s Executive Director Emer Cooke, extending her tenure until 30 April 2027.The Board’s…

Jefferies analysts expect a regulatory filing for rocatinlimab later this year, with a product launch in 2026.

Cullinan Therapeutics and Taiho Oncology’s zipalertinib elicited promising response rates in two mid-stage studies of non-small cell lung cancer patients with typical and uncommon EGFR mutations.

Former CDC director Susan Monarez and former chief medical officer Debra Houry will appear in front of the Senate HELP Committee on Sept. 17.

ocial media Influencer-turned-entrepreneur Demi Schweers said she first took to Instagram to share content centered around DIY projects, fashion and pets. But after some health complications, Demi, the other half of ‘Demi and Tom’ on TikTok, began posting a more personal side and quickly garnered millions of followers on TikTok.

Novo Nordisk also lowered its full-year profit growth guidance in connection with the restructuring effort. The pharma now anticipates operating profit to grow from 4% to 10%, down from its prior projection of 10% to 16%.

The U.S. Department of Health and Human Services and the Food and Drug Administration today announced sweeping reforms to rein in misleading direct-to-consumer pharmaceutical advertisements.

In a livestreamed meeting Tuesday afternoon, Health Secretary Robert F. Kennedy Jr. drew a dark portrait of the state of America’s health while addressing the MAHA Commission’s most recent report, which includes plans to research potential links between vaccines and rising rates of chronic disease.

The FDA is considering changes to the Generally Recognized as Safe (GRAS) regulations, potentially eliminating the self-affirmed GRAS pathway, which allows companies to independently determine and affirm the safety of food additives without notifying the FDA. This move, directed by Health and Human Services Secretary Robert F. Kennedy, Jr., aims to increase transparency and efficiency but raises concerns about FDA resources and potential legal challenges. Stakeholders, including industry representatives and legal experts, are wary of the impact on the food and dietary supplement sectors, emphasizing the need for stakeholder consultation to avoid market disruptions. The proposed changes have prompted discussions on alternative approaches, such as using AI to streamline the review process, though the lack of statutory authority for mandatory GRAS notifications remains a contentious issue.

Insitro, Firefly Bio and Superluminal Medicines are among the first participants in Lilly’s “TuneLabs” platform, which the pharma says can help young drugmakers while training its own models.

Webpage providing notices of updates to FDA’s STIC webpages for antibacterial and antifungal drugs.

Executives at Novartis have not been shy about a desire to buy more companies, with cardiovascular a big focus. In total, the Swiss pharma has put $17.23 billion on the line in M&A and licensing deals this year.

After receiving a complete response letter for its pyruvate dehydrogenase complex deficiency candidate, Saol Therapeutics anticipates it will need “several years” and “significant financial resources” to address the FDA’s concerns.

Truist Securities called pumitamig’s data on Monday “very reassuring,” given the consistency between its performance in Chinese and global patient populations.

Ori Biotech’s CEO said the prioritization of review by FDA, coupled to the impact of the technology, could shave up to three years off development timelines.

With two late-stage programs set to read out in the next 48 months, Biogen is translating its wealth of experience in multiple sclerosis to lupus—developing a pipeline BMO Capital Markets analysts called “thoughtful.”

The Bristol Myers-partnered bispecific antibody kept small cell lung cancer under control in participants enrolled in a Phase 2 trial.

Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(o)(4)) authorizes FDA to require application holders for certain drugs to make labeling changes based on new safety information. Learn more.

Health Canada and the Public Health Agency of Canada have conducted a broad review of regulations and program administration to identify outdated, inefficient or duplicate regulations that hinder economic growth and create unnecessary burden for businesses and people in Canada.

The 2025 Bioprocessing Summit revealed knowledge gaps and changing mindsets. As some companies look towards the future, others struggle with the present and past.

The companies said their updated shot spurred an increase in neutralizing antibodies against currently circulating strains, answering calls for more corroborating evidence.

Presenting at the World Sleep Congress 2025, the Dublin-based company’s Phase II study bested Takeda drug in both efficacy and safety.

The Trump administration enacted tariffs against India 10 days ago that will impact the country’s botanical sector.

New FDA expert panels, such as recent meetings on SSRI use during pregnancy and on hormone replacement therapy during menopause, are drawing criticism for being one-sided. One leader says such panels are designed to reach a specific conclusion.

Amid an unprecedented turnover in leadership at the FDA and mass layoffs of staff, communication has crumbled and uncertainty runs rampant, leaving small and medium biopharma companies without a clear path forward for their therapies.

The U.S. Food and Drug Administration today approved expanded use of Vonvendi [von Willebrand factor (Recombinant)] for routine preventative (prophylactic) use in adults (age 18 years and older) with all types of von Willebrand disease (VWD) and on-demand and treatment of bleeding episodes and perio

Since the passage of the Biosimilar User Fee Act (BsUFA) in 2012, user fees have played an important role in expediting the process for the review of biosimilar products.