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…

Leerink Partners previews the drugs likely to be subject to the Inflation Reduction Act’s next price negotiations as the program expands to Medicare Part B and smaller biotechs.

Creatine and guanidinoacetic acid (GAA) supplementation may improve esports performance in experienced male gamers, according to new research.

A February executive order on pharmaceutical price transparency does nothing to change the incentives that keep costs opaque. But drug companies and other stakeholders would reap the benefits of such disclosures.

InflaRx’s vilobelimab met the bar for futility in a Phase III trial for the rare skin disease pyoderma gangrenosum.

In a video posted to social media on Tuesday, HHS Secretary Robert F. Kennedy, Jr. claimed that there is a lack of clinical data to support the repeat COVID-19 booster strategy in children.

The European Medicines Agency (EMA) is closed from 18:00 on Wednesday 28 May 2025 until 08:30 on Monday 2 June 2025.The product emergency hotline is available outside working…

Nearly two years in with Zurzuvae, Biogen tackles an ‘all of the above market’ to find patients and battle stigma in postpartum depression.

R&D spending across the global pharmaceutical sector climbed 1.5% in 2024, according to unreleased data from Evaluate Pharma.

List of Active RDRC Sites

The acquisition of SiteOne provides a bit of diversification for Lilly, which has burrowed into the obesity and diabetes space with mega-blockbuster tirzepatide and several follow-on molecules.

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.

In addition to a $140 million series D, GRIN Therapeutics has signed a global licensing deal for the epilepsy disorder drug radiprodil worth $50 million upfront.

Pharmavite recently unveiled its state-of-the-art $250 million gummy production facility in New Albany, Ohio. The massive investment, part of the company’s remarkable 90% growth since 2019, promises to produce billions of gummies annually while creating 225 new jobs.

Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2025

As the World Health Organization initiates a new agreement for coordinating global responses to future pandemics, the future of vaccine development in the U.S. faces growing challenges, including waning funding and regulatory changes, that threaten next-gen COVID-19 vaccine candidates and pandemic preparedness more broadly.

Beginning this week in Chicago, the American Association for Cancer Research’s annual conference will feature presentations that could have far-reaching implications for breast and blood cancers and more.

Information on patents and suitability petitions that impact the availability of generic drugs.

The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.

Information related to FDA’s preparation for the seventh reauthorization of PDUFA.

Find descriptions of some of the documents and actions, such as warning letters, recalls, Form 483 and inspection warrant, involved in DA oversight of compounding facilities.

The report takes from HHS Secretary Robert F. Kennedy Jr’s playbook, calling out rising autism rates, the vaccine schedule and over medication of children as reasons for chronic diseases.

In an opinion issued late Thursday night, U.S. District Judge Susan Illston wrote that the president and department agency heads do not have the authority to reorganize the government without Congress’ input.

Ten new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended ten medicines for approval at its May 2025 meeting.The committee recommended granting…, Positive recommendations on new medicines , Aucatzyl International non-proprietary name (INN) obecabtagene autoleucel…, Blenrep INN belantamab mafodotin  Marketing-authorisation applicant…, Ezmekly INN mirdametinib Marketing-authorisation applicant…, Itovebi INN inavolisib Marketing-authorisation applicant…, Maapliv INN amino acids Marketing-authorisation applicant…, Positive recommendations on new biosimilar medicines , Bomyntra INN denosumab  Marketing-authorisation applicant…, Conexxence INN denosumab Marketing-authorisation applicant…, Rolcya INN denosumab Marketing-authorisation applicant…, Positive recommendation on new hybrid medicine , Riulvy INN tegomil fumarate  Marketing-authorisation applicant…, Positive recommendation on new generic medicine , Emtricitabine/Tenofovir alafenamide Viatris INN emtricitabine / tenofovir alafenamide…, Withdrawal of initial marketing authorisation application , Teriparatide Ascend INN teriparatide Marketing-authorisation applicant…, Negative opinion of initial marketing authorisation application , Atropine sulfate FGK INN atropine Marketing-authorisation applicant…, Kinselby INN resminostat mesilate Marketing-authorisation applicant…, Positive recommendations on extensions of therapeutic indications , Imfinzi INN durvalumab Marketing-authorisation holder…, Rezolsta INN darunavir / cobicistat  Marketing-authorisation holder…, Saxenda INN liraglutide Marketing-authorisation holder…, Tevimbra INN tislelizumab Marketing-authorisation holder…, Withdrawal of extension of indication , Lutathera INN lutetium Marketing-authorisation applicant…, Re-examination of recommendations , Aplidin INN plitidepsin  More information…, Winlevi INN clascoterone More information Winlevi…, Start of referral procedure , Ipidacrine INN ipidacrine More information EMA…, Outcome of referral procedure , Azithromycin containing medicinal products for systemic use INN various More…, Other updates , Start of Union reviews adopted during the CHMP meeting of 19-22 May 2025AdoptedReference Number: EMA/170235/2025 English (EN…

Analysts were effusive about Merus’ new HNSCC data, writing that petosemtamab could “become the standard of care” in the first-line setting for this indication.

EudraVigilance registration manual

The approval tees GSK up to challenge Sanofi and Regeneron, which in September 2024 won the first biologic approval for COPD for their blockbuster antibody Dupixent.

The “One Big Beautiful Bill Act” includes negotiation exemptions for orphan drugs approved to treat more than one rare disease and has implications for PBMs. Also on Thursday, the White House released its MAHA report with a mission to “make our children healthy again.”

The advisory committee meeting comes days after the FDA unveiled a new risk-based approval framework for COVID-19 vaccines.

EMA’s human medicines committee (CHMP) has started a review of medicines containing ipidacrine. These medicines have been authorised in several EU countries through national…