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…

The landmark Women’s Health Initiative (WHI) will not be defunded after all, according to the latest from the Department of Health and Human Services (HHS).

The rising use of GLP-1 agonists to help manage the obesity epidemic is not only reshaping how consumers taking the medication approach food, but it is also raising awareness among the broader population about the role of nutrition and their health – creating opportunities and challenges for manufacturers and ingredient suppliers

Explore the FDA’s Competitive Generic Therapy Approvals page, offering insights into the program designed to encourage generic drug competition. Access information about approved CGT products and find resources, including a downloadable CGT approvals spreadsheet.

The transaction, which sources say could be agreed upon as soon as Monday, would price SpringWorks at $47 per share, totaling approximately $3.5 billion for the acquisition.

Big compounders will have until May 22 to stop producing and dispensing compounded semaglutide, while smaller, state-run pharmacies must immediately stop making copies of the blockbuster drug.

Despite steep budget and staffing cuts at the FDA in recent weeks and other headwinds, Gilead CEO Daniel O’Day assured investors that the pharma’s plans and preparations for lenacapavir’s launch remain on track.

Presentations at this year’s American Association for Cancer Research meeting could have a broad impact on the treatment landscape for head and neck and lung cancer, and implications for specific drug modalities like TIGIT and VEGF.

Heart Pump Accessory Removal: Abbott Removes HeartMate Mobile Power Unit due to Instances of Sudden Power Loss

This page contains the AADPAC roster, which lists the current members and the current number of vacancies for the committee.

Net sales of Cobenfy, whose success is imperative for Bristol Myers, totaled $27 million in the first quarter, handily beating Wall Street expectations.

FDA is alerting health care providers and lab staff of reports of false positives when using certain Micro Capillary Blood Collection tubes with the LeadCare Testing Systems.

Despite a dip in sales and a recent schizophrenia stumble, the company drew an optimistic outlook for sales for the rest of the year, even as the specter of pharmaceutical tariffs looms.

Merck, Bristol Myers Squibb, Sanofi and Roche had little clarity on the potential impact of President Donald Trump’s pharmaceutical tariffs but many companies are already preparing for what’s to come.

Granite will focus on two antibody therapies, both targeting crucial players in the inflammatory cascade to address autoimmune diseases.

In this episode presented by DIA, BioSpace’s head of insights Lori Ellis discusses how collaboration and investment shape the the future of women’s health with Martin Hodosi, partner at Kearney and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine.

With a new raise provided by Flagship Pioneering, the new company is aiming to find “the silent window” before disease symptoms set in.

The FDA is asking Novavax for a non-mandatory postmarketing commitment to produce additional clinical data for its investigational COVID-19 vaccine.

The tradipitant saga stretches back to September 2024, when the FDA declined to approve Vanda’s drug in gastroparesis, a stomach condition characterized by delayed gastric emptying.

Proquad is rarely a newsmaker from Merck’s earnings, but this time around, the U.S. has had a series of measles outbreaks. Sales of the vaccine were $539 million for the quarter, a 5% decline from the same period in 2024.

Where thousands of former Health and Human Services employees will work next is unknown, but biopharma companies likely aren’t the main destination. Two biopharma executives discuss potential landing spots.

Founded in 2007, Steminent Biotherapeutics specializes in developing innovative stem cell-based therapeutics that offer new hope for patients with rare neurodegenerative diseases

In this discussion, our guests explore how recent regulatory changes are shaping the future of AI in drug development in the US market. Watch now.

Kristi Serena of Mibelle Biochemistry shared her inspiring journey, one that redefines conventional views on education and family structures.

The deal is a blast from the not-too-distant past, when special purpose acquisition companies were an easy way for companies to list on the public market with a bundle of cash to operate on.

The U.S. Food and Drug Administration could be open to leveraging external data from mature dietary supplement audit programs to inform FDA inspectional planning process, a senior agency figure stated recently. The official also outlined FDA’s fact-finding mission around gummies to better understand the dosage form and what comes next

Roche’s Genentech is betting on the Flagship Pioneering–founded company’s discovery platform called DECODE to find new targets for an undisclosed autoimmune disorder.

A late-stage study found Cobenfy wasn’t better than a placebo as an add-on to atypical antipsychotics. Some analysts view the failure as a “significant hit” to the drug’s commercial outlook.

Executives don’t just get paid big bucks to operate a company. Sometimes they get paid millions to walk away.

Biotech was starting to show signs of recovery after years of investor pullback—until new tariffs and economic uncertainty sent fresh shockwaves through an already fragile market.