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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 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.

Paul Stoffels left his perch as J&J’s chief scientific officer in 2022 to replace Galapagos’ founding CEO Onno van de Stolpe, inheriting a company that had suffered a series of clinical failures since its 1999 creation.

The big pharma joined several of its peers in committing to invest billions of dollars in new and expanded manufacturing facilities in the U.S. 

Alnylam and BridgeBio are competing for people who are switching from Pfizer’s blockbuster ATTR amyloidosis drug tafamidis while all three companies are fighting for new patients.

Analysts at Leerink Partners said in a Monday note that DESTIN-Breast09’s findings “could support an approval” for Enhertu in first-line HER2+ metastatic breast cancer.

Novo Nordisk filed for approval of an oral, 25-mg formulation of its weight loss blockbuster “earlier this year,” according to a company spokesperson.

FDA is soliciting general comments on GDUFA II Program Fee: List of Abbreviated New Drug Application Sponsors and Application Numbers. The information gathered from public comments will assist FDA in accurately assessing FY 2018 GDUFA Program Fees in a timely manner.

A spokesperson confirmed the Danish drugmaker has asked U.S. regulators to clear an oral version of its weight loss drug Wegovy two years after reporting initial Phase 3 results.  

FDA Commissioner Marty Makary last week announced a directive that would limit industry participation in the agency’s advisory committees. But not only do company reps serve only as non-voting members, a 1997 law actually requires industry involvement.

California-based Tempest Therapeutics is laying off 21 of its 26 full-time employees. The cuts come while the biotech is exploring strategic alternatives, including a merger or acquisition, as it tries to move its investigational PPARα antagonist into late-stage development.

Disruptive conditions are typical in non-Western markets. The U.S. industry, thrown into a period of significant change as the Trump administration overhauls HHS and considers implementing tariffs, could learn a thing or two by looking overseas.

Dupixent, which was rejected by the FDA for chronic spontaneous urticaria in October 2023, is now approved as the first new targeted therapy for the indication in more than 10 years.

Alis Biosciences says its goal is to return to investors billions of dollars stuck on the balance sheets of “moribund” biotech companies that have suffered significant setbacks.  

The partners overcame an earlier rejection to win a seventh use for Dupixent, though some analysts are skeptical of its sales potential compared to other emerging medicines for the condition.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Commissioner Martin Makary said the agency would, whenever possible, restrict drug company employees from participating as industry representatives on advisory committees.

U.K. regulators cleared a multiple myeloma drug GSK withdrew from market three years ago. Elsewhere, an investment firm pressed Elevation Oncology to liquidate and the FDA relaxed risk monitoring requirements for Camzyos.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Consumer surveys have been around for over a century, with documented examples dating back as far as the late 1800s. But that approach can only go so far. What if you could push behavioral research boundaries by tapping into the subconscious? That’s exactly what InsightsNow is doing to truly understand ingredient preferences.