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 CDC’s changes threaten to cut vaccine sales for makers including Pfizer, Moderna, Merck and more, but a legal expert suspects affected manufacturers will stay on the sidelines rather than back a push to declare the revised schedule unlawful.

This week’s Capitol Hill meetings come on the heels of rejections of ultra-rare disease drugs developed by Biohaven and Saol Therapeutics. Physicians and patient groups implored the FDA to expedite these treatments.

FDA Commissioner Marty Makary presented a new idea to staff this week: bonus payments for employees that complete regulatory review processes faster than expected.

Hernexeos is the second drug to secure an FDA approval under the agency’s priority voucher scheme, following in the footsteps of USAntibiotics’ Augmentin XR, which was granted the ticket in December 2025.

Aside from creating a toxic work environment, CBER Director Vinay Prasad has also been accused of berating his staff and retaliating against reviewers who questioned his decisions.

Without naming a specific product, Commissioner Marty Makary referred to an investigational therapy, delivered surgically into the brain, that the FDA was “pressured” to approve even after finding no clinical benefit to patients.

Drug Trials Snapshots: EXDENSUR

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12 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its February 2026 meeting.The committee recommended…, CHMP statistics Key figures from the February 2026 CHMP meeting are represented in the graphic below. , CHMP statistics:…, Positive recommendations on new medicines, mCombriax Common name Influenza and COVID 19, mRNA vaccine Marketing authorisation applicant Moderna Biotech Spain S.L. Therapeutic indication Immunisation…, Ojemda INN tovorafenib  Marketing authorisation applicant Ipsen Pharma  Therapeutic indication Treatment of paediatric low-grade glioma (LGG).…, Onerji INN levodopa / carbidopa  Marketing authorisation applicant Tanabe Pharma GmbH Therapeutic indication Treatment of motor fluctuations in patients…, Palsonify INN paltusotine Marketing authorisation applicant Crinetics Pharmaceuticals Europe GmbH Therapeutic indication Medical treatment of adult patients…, Rhapsido INN remibrutinib Marketing authorisation applicant Novartis Europharm Limited Therapeutic indication Treatment of chronic spontaneous urticaria (CSU…, Xolremdi INN mavorixafor Marketing authorisation applicant X4 Pharmaceuticals (Austria) GmbH Therapeutic indication Treatment of WHIM syndrome. More…, Positive recommendations on new biosimilar medicines, Bysumlog INN insulin lispro  Marketing authorisation holder Gan & Lee Pharmaceuticals Europe GmbH Therapeutic indication Treatment of diabetes…, Dazparda INN insulin aspart  Marketing authorisation applicant Gan & Lee Pharmaceuticals Europe GmbH Therapeutic indication Treatment of diabetes…, Fubelv INN etanercept  Marketing authorisation holder Biosimilar Collaborations Ireland Limited Therapeutic indication Treatment of rheumatoid arthritis…, Poherdy INN pertuzumab Marketing authorisation holder Organon N.V. Therapeutic indication Treatment of breast cancer in adults.  More information…, Tuyory INN tocilizumab  Marketing authorisation holder Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.) Therapeutic indication Treatment of…, Zandoriah INN teriparatide  Marketing authorisation holder Cinnagen Co Unipessoal Lda. Therapeutic indication Treatment of osteoporosis. More…, Positive opinions for medicines intended for use outside EU, Acoziborole Winthrop International non-proprietary name (INN) acoziborole  Marketing authorisation applicant Sanofi Winthrop Industrie  Therapeutic…, Negative recommendation on new medicines, Daybu INN trofinetide Marketing authorisation holder Acadia Pharmaceuticals (Netherlands) B.V. Orphan designation This medicine was designated an orphan…, Iloperidone Vanda Pharmaceuticals INN iloperidone  Marketing authorisation holder Vanda Pharmaceuticals Netherlands B.V. More information Iloperidone…, Positive recommendations on extensions of therapeutic indications , Dupixent INN dupilumab  Marketing authorisation holder Sanofi Winthrop Industrie More information Dupixent : pending EC decision, Jorveza INN budesonide  Market authorisation holder Dr. Falk Pharma GmbH More information Jorveza : pending EC decision, Keytruda INN pembrolizumab Market authorisation holder Merck Sharp & Dohme B.V. More information Keytruda : pending EC decision, Olumiant INN baricitinib Market authorisation holder Eli Lilly Nederland B.V. More information Olumiant : pending EC decision, Scemblix INN asciminib Market authorisation holder Novartis Europharm Limited More information Scemblix : pending EC decision, Stelara INN ustekinumab Market authorisation holder Janssen-Cilag International NV More information Stelara : pending EC decision, Withdrawals of initial marketing authorisation application, Zumrad INN sasanlimab  Marketing authorisation applicant Pfizer Europe MA EEIG More information Zumrad : pending EC decision

The BioSpace team hit the ground running at the J.P. Morgan Healthcare Conference earlier this month to bring you the news from the streets of San Francisco.

The Food and Drug Administration is advising consumers not to purchase or use ULTRA ADVANC3 sold on www.amazon.com or ULTRA ADVANC3 GOLD sold on www.naturistarex.com. These products are promoted and sold for joint pain on various other websites and possibly in some retail stores.

After a rocky 2025, Sarepta Therapeutics’ executives admit they have work to do to bring patients back into the fold as sales of Duchenne muscular dystrophy gene therapy Elevidys continue to decline.

Last week, the FDA made its one pivotal trial policy official, sparking myriad questions from industry leaders, including around specific evidence required for the single study and why it hasn’t been implemented across all therapeutic areas before now.

In this episode of Denatured, you’ll be listening to Indu Navar, CEO and founder of EverythingALS and Dr. Olga Uspenskaya, chief medical officer at VectorY Therapeutics. We’ll be speaking about patient-pharma collaborations accelerating trials and hope, advances in ALS biology understanding and biomarker-driven endpoints.

While Boehringer Ingelheim hasn’t yet revealed what diseases it will go after, Sitryx’s oral drug candidate could potentially be disease-modifying for a variety of autoimmune and inflammatory conditions.

Novo Nordisk reported a loss in a head-to-head trial of CagriSema against Lilly’s Zepbound earlier this week. This time around, Lilly’s orforglipron bested Novo’s oral semaglutide in blood sugar control and weight reduction—albeit with a few extra discontinuations as compared to its rival.

The rejection of Atara Biotherapeutics’ Ebvallo in January was a “complete reversal” of the conesensus FDA reviewers had come to, according to a former agency employee, who said manufacturing problems were the only approvability barrier for the drug.

At the 2026 Conference on Retroviruses and Opportunistic Infections, Gilead and Merck demonstrated that their respective daily oral HIV drugs can match current therapies in keeping the virus at bay.

Pfizer will be responsible for all global clinical and regulatory activities for Beam Therapeutics’ liver-directed gene editor.

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Looking for a biopharma job in San Francisco or South San Francisco? Check out the BioSpace list of 10 companies hiring life sciences professionals like you.

When Doug Ingram became Sarepta Therapeutics’ CEO in 2017, he didn’t have a connection to muscular dystrophy, but he has developed a fierce passion for the therapeutic area. He will step aside from his role to dedicate more time to his family.

This listing includes accelerated approvals (AAs) for non-malignant hematological, neurological, and other disorder indications with postmarketing trials that have been subsequently withdrawn, and are therefore, no longer FDA-approved.

The Denton site is part of a network of manufacturing plants Novartis is building across the U.S. to make cancer drugs that must be shipped to patients quickly.

After its next-generation obesity asset CagriSema lost a head-to-head matchup with Eli Lilly’s Zepbound, Novo Nordisk is throwing more money into the obesity space, striking a deal with Vivtex to advance novel weight loss pills.

In his State of the Union address on Tuesday evening, President Donald Trump urged Republican leaders to pass legislation cementing his new drug pricing initiatives as he touted his efforts to lower healthcare costs for Americans.

LB Pharma needed $350 million to advance a promising schizophrenia candidate at a time when the biotech markets were locked up tight. Fortunately, it wasn’t CEO Heather Turner’s first rodeo.

Regulators overseeing rare disease treatments need better tools to weigh competing risks in real time. Sarepta Therapeutics’ Elevidys is a prime example of why.

Impella Generation 1 Purge Cassettes have an increased risk of purge leaks. Purge leaks can lead to low pump pressure and pump stops