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…

Small and large drugmakers alike have made big, proactive moves to secure the production capacity that will be vital to serving the weight loss market.

FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure Issues

FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure Issues

The FDA is enhancing its inspection processes in the dietary supplement industry, focusing on compliance and self-regulation to improve food safety. New initiatives include the use of AI for data analysis and unannounced inspections, along with a push for transparency in ingredient safety. The agency is also considering reforms to the GRAS rule to close existing loopholes, while industry experts discuss potential impacts on innovation and regulatory processes.

The company, which is developing a competitor to Cobenfy, aims to become one of rare biotechs to price a large IPO of late.

The company was expecting a decision from the FDA by Sept. 28 for its oral drug tolebrutinib, but an update to the drug’s application package convinced the agency to take more time to review.

Join us for the 2025 Advancing Generic Drug Development Workshop! FDA experts will demonstrate the FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program’s transformative impact on generic drug development, regulation, and approval.

In Summer 2025, the dietary supplement industry saw significant leadership changes, with companies like The Vitamin Shoppe, MeriCal, and Shaklee appointing seasoned executives to drive digital transformation, innovation and market expansion. Key appointments include Mike Forbes at The Vitamin Shoppe, Susan Hazels Mitmesser at MeriCal, and Asma Ishaq at Shaklee. The legal landscape also evolves with Amin Wasserman Gurnani expanding its litigation practice, and the FDA appointing Sean Keveney as chief counsel. These changes mark a period of strategic growth and regulatory focus across the industry.

EMA welcomes the publication of the European Commission’s (EC) new Variations Guidelines, which streamline the lifecycle management of medicines (see EC news). These guidelines…

The FDA’s proposed Rare Disease Evidence Principles review process is a starting point for getting rare disease therapies across the finish line, but industry leaders say there are more concrete steps the regulator could take to help patients.

With AbbVie’s $1.2 billion acquisition of Gilgamesh Pharmaceuticals’ lead depression drug, the psychedelic therapeutics space has soundly rebounded from Lykos’ rejection last year. There are now seven programs in Phase III trials across the sector, with multiple companies vying for that first approval.

CENTER VALLEY, Pa., (September 19, 2025) — Olympus Corporation has announced a voluntary, global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles (“ViziShot 2 FLEX”) manufactured prior to May 12, 2025, after receiving reports of device components detaching during procedures

A decade-long journey has come to an end for Stealth BioTherapeutics and the Barth syndrome community with the first-ever treatment for this uncommon mitochondrial disease. CEO Reenie McCarthy called it a “pivotal victory” that “offers hope for expedited regulatory attention to other ultra-rare diseases.”

MIDD Pilot Program Frequently Asked Questions (FAQs)

After a tumultuous two-day meeting marked by confusion and missteps, an advisory committee endorsed guidelines that would urge people discuss vaccination's benefits and risks with their physician.

FDA scientists carry out laboratory, clinical and analytical research to address knowledge gaps in drug development, healthcare technologies and post-market drug monitoring. Spotlight on CDER Science features noteworthy scientific and research-oriented activities conducted within CDER.

After a tension-packed two days that saw recommended changes to the MMRV vaccine schedule and COVID-19 vaccine access, as well as a delayed hepatitis B vaccine vote, policy experts expressed concern with the reconstituted committee’s dearth of previous experience and understanding of their role.

Pfizer and Arvinas plan to out-license their partnered drug vepdegestrant. Elsewhere, Novo shared more data for oral Wegovy and Vertex reached a deal in Italy for coverage of its gene editing medicine Casgevy. 

The American Herbal Products Association held its annual congress to discuss topics like trade, wildcrafting and herb market trends.

Bluebird bio has re-emerged after a private equity buyout as Genetix Biotherapeutics, marking a return to its roots and a new path forward for manufacturing.

A study published in the journal *Nutrients* examined the effects of pomegranate extract on IGF-1 levels and telomere length in older adults. The study found that supplementation with pomegranate extract increased IGF-1 levels, which may support healthy aging, although it did not significantly affect telomere length. The researchers suggest that the increase in IGF-1 could be beneficial for musculoskeletal health and oxidative stress reduction, but emphasize the need for further long-term studies to fully understand the implications for longevity.

A study published in *Frontiers in Nutrition* assessed the bioavailability of Lipo CoQ-10 using LipoVantage technology compared to standard CoQ10 and a placebo. The liposomal formulation showed significantly higher absorption, with a 31.3% increase in Cmax and 22.6% increase in AUC0-24h. The study, involving 18 participants, highlighted the potential for improved absorption with liposomal CoQ-10, although it noted that single-dose administration did not significantly affect systemic oxidative stress or inflammation. Future research is suggested to explore long-term benefits across various populations.

Members of ACIP voted to table a planned vote on withholding some infants’ first hepatitis B vaccine dose, adding more confusion to an already muddied meeting.

BMO Capital Markets analysts said the first day of the CDC vaccine advisory committee meeting Thursday had anti-vaccine overtones as the panel, which was revamped by Health Secretary Robert F. Kennedy, Jr. in June, voted to recommend that children under four receive the measles, mumps, rubella (MMR) vaccine separately from a chickenpox vaccine. Today the advisors will vote on changing the childhood schedule for the hepatitis B and COVID-19 vaccines.

Investors had been “holding out hope” that there remained a regulatory path forward for RP1, but results of Replimune’s Type A meeting with the FDA do not appear to support this, according to BMO Capital Markets.

The House Committee on Energy and Commerce has cleared proposed legislation that could bring back the FDA’s rare pediatric priority review voucher program, which allows for expedited drug reviews.

Nektar Therapeutics still needs to establish what differentiates rezpeg from other atopic dermatitis therapies, according to analysts at William Blair.

EMA’s human medicines committee (CHMP) has recommended extending the therapeutic indication of Uplizna (inebilizumab) to include the treatment of adult patients with active…

Procedural advice on appointment and responsibilities of the CVMP rapporteur and co-rapporteur in accordance with Article 140(6) of Regulation (EU) 2019/6, and peer reviewer