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 settlement agreement will extend market exclusivity for AbbVie’s JAK inhibitor in the U.S. until 2037—providing pediatric exclusivity is granted.

This page provides drug and nonvaccine biological product manufacturers, distributors, packers, outsourcing facilities, and other interested parties with information about FDA Adverse Event Reporting System (FAERS) electronic submissions and instructions on how to electronically submit postmarketing

Ocaliva won accelerated approval for primary biliary cholangitis in 2016, which the FDA refused to upgrade to full approval last year after an advisory committee was unable to verify a favorable risk/benefit profile.

President Donald Trump is considering tariff exemptions for certain “non-patented” pharmaceuticals, though the White House has yet to release specific guidelines.

CVMP opinions on veterinary medicinal productsThe Committee adopted, by majority, a positive opinion for a marketing authorisation from Zoetis Belgium for Portela (…

DreamStation devices may deliver incorrect therapy due to programming errors. Continued use could cause ineffective treatment or harm.

Dexcom is correcting G7 & ONE+ Apps that fail to alert users when sensors fail, potentially causing missed alerts and delayed treatment of hypo/hyperglycemia.

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

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

DreamStation devices may deliver incorrect therapy due to programming errors. Continued use could cause ineffective treatment or harm.

An HHS spokesperson confirmed Prasad's reappointment as chief medical and scientific officer, one month after his surprising return to the agency as CBER director.

Capsida is investigating the root cause of the death, which occurred in the first patient treated in a trial of the company’s therapy for a rare neurodevelopmental disorder.

LB Pharma landed on the Nasdaq Thursday, with 3 million additional shares sold than expected.

A draft executive order obtained by The New York Times purports to clamp down on the pharmaceutical industry’s ability to buy new molecules from biotechs based in China, along with a number of other proposed reforms.

Ixoreal Biomed is launching SRI-81 Shatavari, an Ayurvedic herb known as the “Queen of Herbs,” to support women’s health. The launch at SupplySide Global 2025 in Las Vegas marks a significant entry into the U.S. market, aiming to establish SRI-81 as a global standard for shatavari extract. The company emphasizes science, quality and sustainability, with SRI-81 backed by 10 clinical trials focusing on women’s health issues like menopause and hormonal balance. Ixoreal’s vertically integrated approach ensures complete supply chain control, reflecting their commitment to both product quality and ethical farming practices.

The biopharma job market remains challenging, based on BioSpace data. In August, job postings live on the website dropped 32% year over year. In addition, during the first eight months of 2025, over 26,000 people were laid off or projected to be laid off.

Stories illustrating how regulatory science impacts the lives and health of people

New York City has seen increased life sciences employment during the past decade as public funding and key projects like JLABS @ NYC have given the area a boost. A Partnership Fund for New York City executive discusses the city’s strengths and a notable challenge facing businesses.

Capsida has yet to disclose the exact cause of death. The patient had received the gene therapy CAP-002 for a type of epilepsy.

Analysts at BMO Capital Markets expect the lack of other exon-44-skiping therapies to facilitate a “smooth” approval process for Avidity’s del-zota.

New draft guidelines suggest the FDA is open to exercising regulatory flexibility for non-opioid drugs being developed for chronic pain.

Claiming that the domestic market undervalues pharma innovation, Merck has decided to pull the plug on all of its R&D efforts in the U.K.

The future of robotics is being shaped by powerful technologies like AI, edge computing, and high-speed connectivity, driving smarter, more responsive machines across industries. Robots are no longer confined to static environments—they are evolving to interact dynamically with humans and their surroundings.

This eBook explores the impact of robotics in diverse fields, from home automation and medical technology to automotive, data centers, and industrial applications. It highlights challenges like power efficiency, miniaturization, and ruggedization, while showcasing Molex’s innovative solutions tailored for each domain.

Additionally, the eBook covers:

• Ruggedized connectors for harsh industrial settings
• Advanced power management for home robots
• Miniaturized systems for precision medical robotics
• 5G/6G-enabled autonomous vehicles
• High-speed data solutions for cloud infrastructure

LB Pharmaceuticals, which has a schizophrenia medicine headed for late-stage testing, broke one of the longest droughts for large IPOs in years.

Establishing trust through thought leadership is no longer optional in today’s cautious biopharma market. This webinar will show leaders how strategic insights and targeted outreach can turn awareness into high-converting leads. Watch now.

J&J executives have said they expect the therapy, Inlexzo, to become a future blockbuster and generate sales that significantly outstrip Wall Street forecasts.

The autoimmune and inflammatory disease–focused company canceled plans to go public earlier this year as the IPO window slammed shut.

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.