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…

“Collaborative discussions” with the FDA encouraged Praxis to submit early next year an approval filing for its epilepsy drug. Elsewhere, Rezolute shares plunged and Centessa announced a new CEO.

Generalized myasthenia gravis is Uplizna’s second new indication this year, after the FDA cleared the anti-CD19 antibody for IgG4-related disease in April.

Blujepa is also approved for uncomplicated urinary tract infection in females 12 years and older.

The 2024–2025 formulations of COVID-19 vaccines had an effectiveness rate of 76% at preventing emergency or urgent care visits in children aged 9 months through four years, according to a new report.

Seven new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2025 meeting.The committee…, CHMP statistics Key figures from the December 2025 CHMP meeting are represented in the graphic below. , CHMP statistics:…, Positive recommendations on new medicines, Anktiva International non-proprietary name (INN) nogapendekin alfa inbakicept  Marketing authorisation applicant Serum Life Science Europe GmbH…, Aumseqa INN aumolertinib  Marketing authorisation applicant SFL Pharmaceuticals Deutschland GmbH Therapeutic indication Treatment of non-small cell lung…, Exdensur INN depemokimab  Marketing authorisation applicant Glaxosmithkline Trading Services Limited Therapeutic indication For severe eosinophilic…, Myqorzo INN aficamten  Marketing authorisation applicant Cytokinetics (Ireland) Limited Therapeutic indication Treatment of symptomatic obstructive…, mNexspike INN COVID-19 mRNA vaccine Marketing authorisation applicant Moderna Biotech Spain S.L. Therapeutic indication Active immunisation to prevent COVID…, Positive recommendations on new biosimilar medicines, Gotenfia INN golimumab  Marketing authorisation applicant STADA Arzneimittel AG Therapeutic indication Treatment of rheumatoid arthritis, juvenile…, Ranluspec INN ranibizumab Marketing authorisation applicant Lupin Europe GmbH Therapeutic indication Treatment of neovascular (wet) age-related macular…, Negative recommendation on new medicine, Blarcamesine Anavex INN blarcamesine  Marketing authorisation applicant Anavex Germany GmbH Therapeutic indication Treatment of Alzheimer’s disease and…, Positive recommendations on extensions of therapeutic indications , Arexvy Common name respiratory syncytial virus (RSV) vaccine (recombinant, adjuvanted) Market authorisation holder GlaxoSmithKline Biologicals More information…, Aspaveli INN pegcetacoplan  Marketing authorisation holder Swedish Orphan Biovitrum AB  More information Aspaveli: pending EC decision, Dovprela INN pretomanid  Marketing authorisation holder Mylan IRE Healthcare Limited More information Dovprela: pending EC decision, Elucirem INN gadopiclenol  Marketing authorisation holder Guerbet More information Elucirem: pending EC decision, Eylea INN aflibercept Marketing authorisation holder Bayer AG More information Eylea: pending EC decision, Mounjaro INN tirzepatide  Marketing authorisation holder Eli Lilly Nederland B.V More information Mounjaro: pending EC decision, Nucala INN mepolizumab  Marketing authorisation holder Glaxosmithkline Trading Services Limited More information Nucala: pending EC decision, Recarbrio INN imipenem / cilastatin / relebactam Marketing authorisation holder Merck Sharp & Dohme B.V.  More information Recarbrio: pending EC…, Simponi INN golimumab Marketing authorisation holder Janssen Cilag International More information Simponi: pending EC decision, Uplizna INN inebilizumab  Marketing authorisation holder Amgen Europe B.V More information Uplizna: pending EC decision, Vueway INN gadopiclenol Marketing authorisation holder Bracco Imaging S.p.A More information Vueway: pending EC decision, Winrevair INN sotatercept  Marketing authorisation holder Merck Sharp & Dohme B.V More information Winrevair: pending EC decision, Withdrawal of initial marketing authorisation application, Jelrix INN autologous cartilage-derived articular chondrocytes, in-vitro expanded Marketing authorisation applicant TETEC Tissue Engineering Technologies AG…, Negative recommendation on extension of therapeutic indications, Hetlioz INN tasimelteon Orphan designation This medicine was designated an orphan medicine. More information Hetlioz: pending EC decision, Article 29(4) referral Melatomed and associated names, Other updates, Vfend INN voriconazole Marketing authorisation holder Pfizer Europe MA EEIG More information Vfend: pending EC decision

Checklist for the submission of Day 215 product information annexes for a post-opinion linguistic review (Word file)

With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.

CGMP/Finished Pharmaceuticals/Adulterated

Shares of AC Immune rose by double-digits on news that the company, encouraged by new data, now intends to ask drug regulators for feedback to “potentially accelerate” the time to an approval filing. 

An unusual tussle over the availability of funds for Apple Tree’s startups led the firm to seek protection from creditors while it restructures.

In a first for the Parkinson’s field, AC Immune’s immunotherapy has stabilized key biomarkers that suggest an effect on the disease’s course.

EMA welcomes the landmark political agreement reached by the European Commission, the European Parliament and the Council of the European Union on the comprehensive reform of…, Today marks a historic milestone for European medicines regulation and for patients across the EU. The revamp of the pharmaceutical legislation will enable EMA and the…, The new legislation will modernise how medicines are developed, authorised and made available to patients across the EU. It is expected to simplify structures and…

Analysts were hoping for a safety profile similar to what was achieved in Phase II but an abnormal sense of touch, called dysesthesia, has emerged in the late-stage TRIUMPH-4 trial.

The FDA is becoming deeply compromised and increasingly at risk of being permanently transformed in ways contrary to its mission, history and culture.

While new late-stage data point to some liver toxicity signals, analysts at BMO Capital Markets said Tukysa’s efficacy outcomes “appear to more than make up for any safety concerns.”

Also on Thursday, Zealand held its Capital Markets Day in London, outlining the strategy for its weight management franchise in the near-term, including launching five products by 2030.

While overall survival remains immature, results so far show a clear trend in favor of Roche’s giredestrant.

Pfizer is in the midst of an aggressive, multi-year cost-cutting effort, which so far has left nearly 2,000 people jobless.

In this episode of Denatured presented by AnaptysBio, Jennifer Smith-Parker speaks to Dr. Joe Murray, Mayo Clinic; Marilyn Geller, the Celiac Disease Foundation; and Dr. Paul Lizzul, AnaptysBio, about the challenges and opportunities facing celiac disease treatment.

The difference between a job and a career is what you walk away with when it ends. Here’s how to evaluate if your role and environment are enabling capability building–and if your title is holding you back.

The guidance addresses questions that manufacturers, packers, distributors, and their representatives (firms) may have when developing FDA-regulated promotional labeling and advertisements for prescription reference products, biosimilar products, and interchangeable biosimilar products.

Backed by Italy-based Fondazione Telethon ETS, Waskyra, for Wiskott-Aldrich syndrome, is the first gene therapy from a non-profit sponsor to win FDA approval.

The FDA has informed Merck, Sanofi and AstraZeneca of the safety investigation into their RSV antibodies, though it remains unclear what regulatory action, if any, will be taken.

The Commissioner’s National Priority Voucher program was launched in June to shorten review times for companies that align with various national priorities, such as improving domestic drug production and supply.

Pfizer deals again in obesity space as Wave and Structure drop splashy weight loss results; what CDER Director Richard Pazdur’s sudden retirement means for biopharma; neuro diseases take center stage at CTAD; and more.

With $6 billion left in firepower, Pfizer is planning transactions in the hundreds of millions to the low-billions range, particularly in internal medicine and immunology and inflammation, Guggenheim reported.

Long a quieter, locally focused industry, Japanese pharma giants are increasingly looking to the rest of the world for deals.

GE HealthCare issues updated use instructions for certain Carestation 600 and 700 series Anesthesia Systems

FOR IMMEDIATE RELEASE – December 10, 2025 – Albuquerque, New Mexico, MediNatura New Mexico, Inc. is voluntarily recalling one lot of ReBoost Nasal Spray to the consumer level. The product has been found to contain yeast/mold and microbial contamination with one species identified as Achromobacter, a