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 company is looking to the highly anticipated launch of a closely watched HIV medicine to offset weakening demand for Trodelvy and its cancer cell therapies.

The cell and gene therapy company is cutting 47 employees and its entire lupus program to focus resources on two CAR Ts. The move follows a reconfiguration last year to move into immunology.

As Marty Makary nears the end of his first month on the job, the FDA Commissioner sat down for two interviews, offering statements that alternatively contradict and jibe with reported events.

Halozyme claims Merck infringed on patents in developing a subcutaneous form of Keytruda. Elsewhere, Vanda’s challenge to an FDA rejection dragged on, while Sanofi revealed an immune drug setback. 

The Food and Drug Administration is advising consumers not to purchase or use Artrifan King, a product promoted and sold for joint pain on various websites, including www.artriking.us, and possibly in some retail stores.

While AbbVie handily beat expectations this quarter, the company faces declining Humira sales and a challenged aesthetics business, plus the same macro headwinds blowing against the entire industry.

16 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 16 medicines for approval at its April 2025 meeting.The CHMP recommended granting a…, Positive recommendations on new medicines , Alyftrek International non-proprietary name (INN) deutivacaftor / tezacaftor / vanzacaftor…, Attrogy INN diflunisal Marketing-authorisation applicant…, Duvyzat INN givinostat Marketing-authorisation applicant…, Sephience INN sepiapterin Marketing-authorisation applicant…, Tepezza INN teprotumumab Marketing-authorisation applicant…, Ziihera INN zanidatamab Marketing-authorisation applicant…, Positive recommendations on new biosimilar medicines , Dazublys INN trastuzumab Marketing-authorisation applicant…, Denbrayce INN denosumab Marketing-authorisation applicant…, Denosumab BBL INN denosumab Marketing-authorisation applicant…, Enwylma INN denosumab Marketing-authorisation applicant…, Izamby INN denosumab Marketing-authorisation applicant…, Junod INN denosumab Marketing-authorisation applicant…, Vevzuo INN denosumab Marketing-authorisation applicant…, Yaxwer INN denosumab Marketing-authorisation applicant…, Zadenvi INN denosumab Marketing-authorisation applicant…, Positive recommendation on new hybrid medicine , Oczyesa INN octreotide Marketing-authorisation applicant…, Positive recommendations on extensions of therapeutic indications , Adcetris INN brentuximab vedotin Marketing-authorisation holder…, Adempas INN riociguat Marketing-authorisation holder…, Amvuttra INN vutrisiran Marketing-authorisation holder…, Calquence INN acalabrutinib Marketing-authorisation holder…, Cystadrops INN mercaptamine Marketing-authorisation holder…, Jivi INN damoctocog alfa pegol Marketing-authorisation holder…, Veklury INN remdesivir Marketing-authorisation holder…, Vyvgart INN efgartigimod alfa Marketing-authorisation holder…, Xofluza INN baloxavir marboxil Marketing-authorisation holder…, Zoonotic Influenza Vaccine Seqirus Common name zoonotic influenza vaccine (H5N8) (surface antigen, inactivated,…, Re-examination of initial marketing authorisation application , Kisunla INN donanemab Marketing-authorisation applicant…, Withdrawal of initial marketing authorisation application , Dazluma INN troriluzole Marketing-authorisation applicant…, Withdrawal of application to change the marketing authorisation , Ngenla INN somatrogon Marketing-authorisation holder…

The hold, placed by the FDA on an early-stage clinical trial of an experimental BET inhibitor, stems from a recent observation of testicular toxicity in canines given the treatment.

McKinsey’s ‘Future of Wellness’ report found that nearly one in five consumers and one in three millennials in the United States prefer personalized wellness solutions. Pelin Thorogood of Radicle Science says that today, more than ever, advanced technologies like AI are accelerating a seismic shift toward personalization.

A 60-day study found that daily supplementation with Somin-On, a standardized ashwagandha extract, significantly improved memory, attention and processing speed in adults with mild cognitive impairment, offering a safe, natural option for age-related cognitive decline.

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.