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A jury has returned a verdict of infringement against Apple Inc., as part of a series of patent disputes with Masimo Corp., producing a damages award of $634...

Breaking news and analysis of the global biotechnology, pharmaceutical, medical device and medical technology sectors. In-depth coverage of innovation,...

Breaking news and analysis of the global biotechnology, pharmaceutical, medical device and medical technology sectors. In-depth coverage of innovation,...

Dexcom Inc. received U.S. FDA clearance for its Smart Basal CGM-integrated basal insulin dosing optimizer. Designed for adults with type 2 diabetes using...

Raqualia Pharma Inc.’s Fimecs Inc. subsidiary has agreed with Astellas Pharma Inc. to add two new targets under their ongoing joint research. Fimecs and...

A disrupted balance between T-effector and T-regulatory cells, together with the activation of autoreactive or alloreactive B cells that generate pathogenic...

The Trump administration has made known that it intends to foster rapid adoption of AI, starting with a repeal of an executive order (EO) issued by the Biden...

Généthon, a nonprofit laboratory created by the AFM-Téléthon, has reported its exclusive, worldwide licensing agreement with Askbio Inc., a subsidiary of...

A new oral HER2-directed breast cancer therapy from Bayer AG, and its companion diagnostic from Thermo Fisher Scientific Inc., have been approved by the U.S....

Cornerstone Robotics Ltd. raised an oversubscribed $200 million series D round to accelerate commercialization of its flagship product, the Sentire Endoscopic...

Breaking news and analysis of the global biotechnology, pharmaceutical, medical device and medical technology sectors. In-depth coverage of innovation,...

Breaking news and analysis of the global biotechnology, pharmaceutical, medical device and medical technology sectors. In-depth coverage of innovation,...

Med-tech financings with reported values reached $23.33 billion through the first three quarters of 2025, putting the sector on pace to surpass last year’s...

Boston Scientific Corp. looked ready to keep steamrolling down the acquisition path, carrying the momentum from last year, with the news that it is acquiring...

Join us for timely and focused one-on-one interviews with the same key sources we typically interview for BioWorld articles such as company founders,...

News about new and emerging companies

Driven by prescription drug prices and oft-repeated claims that nearly every drug developed in the U.S. owes its origins to taxpayer-funded research, watchdog...

Overture Life SLU secured CE mark certification for its Davitri system that automates the vitrification and thawing of oocytes and embryos, making the...

Breaking news and analysis of the global biotechnology, pharmaceutical, medical device and medical technology sectors. In-depth coverage of innovation,...

Over a span of five-and-a-half months this year, 3.5% of the more than 11,000 clinical trials funded by the U.S. NIH had their grants terminated, according to...

Newco Trogenix Ltd. has emerged from incubation and raised £70 million (US$94.1 million) in a series A, as it prepares the ground for a U.S/U.K. clinical...

Daily news focused on drug discovery, delivery and preclinical research. Coverage includes: Congress highlights, key studies from peer-reviewed journals,...

Nectin-4 is a cell-adhesion molecule that is highly expressed in several malignancies, including bladder, colorectal, lung and breast cancers, while exhibiting...

Breaking news and analysis of the global biotechnology, pharmaceutical, medical device and medical technology sectors. In-depth coverage of innovation,...

The European Commission posted a series of proposed legislative updates, including the AI Act, which might not come into force for the med tech industry until...

Breaking news and analysis of the global biotechnology, pharmaceutical, medical device and medical technology sectors. In-depth coverage of innovation,...

Breaking news and analysis of the global biotechnology, pharmaceutical, medical device and medical technology sectors. In-depth coverage of innovation,...

Adolore Biotherapeutics Inc. has announced that the FDA has granted orphan drug designation to the company’s Kv7-activating rdHSV-CA8* gene therapy for...

Patients and their doctors are no fans of long-term use of direct oral anticoagulants (DOACs) after ablation treatment for atrial fibrillation, but three-year...

Ukko Inc. has announced plans to initiate clinical trials with UKK-0018 for peanut allergy in the first half of this year.

GE Healthcare Technologies Inc. agreed to purchase medical imaging company Intelerad Medical Systems Inc. for $2.3 billion in cash, boosting its capabilities...

Triple-negative breast cancer (TNBC) is notoriously difficult to treat because it is quite aggressive and the tumors do not express the three major surface...

Breaking news and analysis of the global biotechnology, pharmaceutical, medical device and medical technology sectors. In-depth coverage of innovation,...

The U.S. FDA’s September 2022 final guidance for clinical decision support (CDS) systems set a dismal record for pushback, but the new administration at the...

Breaking news and analysis of the global biotechnology, pharmaceutical, medical device and medical technology sectors. In-depth coverage of innovation,...

Venetoclax has shown good results for adult acute myeloid leukemia (AML) in combination with azacitidine, but there is increasing evidence of inherent and...

CSL Ltd. is out-licensing its interleukin-6 (IL-6) monoclonal antibody, clazakizumab, to Eli Lilly and Co. in a deal that brings CSL $100 million in up-front...

Edwards Lifesciences Corp. said it is scrapping plans to acquire Jenavalve Technology Inc. for $945 million after a federal court ruled against the company in...

In an effort to identify stronger and safer α-glucosidase inhibitors, researchers at the Chinese Academy of Sciences prepared a series of diarylpentane...

Siemens AG will deconsolidate its remaining 67% stake in Siemens Healthineers AG to a significant minority as it looks to have greater flexibility in capital...

Kedrion SpA’s investigational plasma-derived treatment for congenital aceruloplasminemia has been awarded European orphan drug designation by the EMA. The...

Surgical robotics maker Shenzhen Edge Medical Co. Ltd. reported its initial public offering on the Hong Kong Stock Exchange to raise HKD$1.19 billion (US$154...

A week after catching Moderna Inc. and its investors off guard with a refuse-to-file letter, the U.S. FDA has reversed course on the company’s BLA submission...

In a big week for W.L. Gore & Associates Inc., the company reported plans to acquire Conformal Medical Inc. and received U.S. FDA approval for its Viabahn...

Breaking news and analysis of the global biotechnology, pharmaceutical, medical device and medical technology sectors. In-depth coverage of innovation,...

Daily news and analysis of the global biotechnology and pharmaceutical industries. In-depth coverage of business, financing, regulation, science, innovation,...

Nektar Therapeutics Inc. has established an academic research collaboration with the University of California, San Francisco (UCSF) to explore the role of...

Researchers from Paratus Sciences Corp. presented the preclinical profile of PS-1001, a novel pan-inflammasome inhibitor designed to prevent IL-1β and IL-18...

Daily news and analysis of the global biotechnology, pharmaceutical and medical technology industries.

Bacillus anthracis is a spore-forming soil bacterium that becomes metabolically active when taken up by a host, causing anthrax. Research efforts are now...

The U.K. National Institute for Health and Care Excellence posted a draft update on its recommendations for ovarian cancer testing, proposing several changes...

Daily news focused on drug discovery, delivery and preclinical research. Coverage includes: Congress highlights, key studies from peer-reviewed journals,...

Head and neck squamous cell carcinoma (HNSCC) accounts for high number of new diagnoses each year. Current management is based on surgery followed by...

Levron Medical Ltd. recently exited stealth mode to advance its cardio-respiratory physiology assist technology, designed to treat heart failure by...

Index of BioWorld infographics

After raising $61 million in a series B round, Vibrant Therapeutics Inc. is gearing up to begin a U.S. phase I trial with its lead program, VIB-305, a masked...

Ventus Therapeutics Inc. has nominated VENT-04, a first-in-class, allosteric caspase-4/5 inhibitor, as a development candidate.

Researchers have explored the effects of human umbilical cord mesenchymal stem cells (hUC-MSCs) on cognitive recovery in anti-N-methyl-D-aspartate receptor...

Scientists in the U.K. are developing glucose-powered bioelectronics to advance the use and capabilities of implantable medical devices. A research team, led...

Nonprofit Finding Hope for Frizzle (FRRS1L) and Apertura Gene Therapy have signed a license agreement for the development of a gene therapy for FRRS1L disease,...

Shanghai Henlius Biotech Inc. has entered into an exclusive global license agreement with U-mab Biopharma (Lianyungang) Co. Ltd., securing rights to a...

NIH researchers report that in severe influenza, survival improves at late stages only when antivirals are combined with therapies that repair lung damage or...

Korsana Biosciences Inc. has emerged from stealth, with its development of therapeutics to treat neurodegenerative diseases initially focused on Alzheimer’s...

Myrio Therapeutics Pty Ltd. has been able to accomplish something no other company has yet been able to crack: to develop binders where both the affinity and...

Breaking news and analysis of the global biotechnology, pharmaceutical, medical device and medical technology sectors. In-depth coverage of innovation,...

It’s the biological resource that keeps on giving, and now UK Biobank has released the final tranche of data on the levels of 249 metabolites in the blood of...

Smith+Nephew plc (S+N) has agreed to acquire Integrity Orthopaedics Inc. for up to $450 million in a bid to strengthen its shoulder repair portfolio. The move...

UNESCO has adopted the first set of global standards on the ethics of neurotechnology amid the rapid advancement in the development of the technologies and...

Mabloc LLC has established a strategic partnership with Instituto Butantan to co-develop and manufacture MBL-YFV-01, a monoclonal antibody therapy for yellow...

Breaking news and analysis of the global biotechnology, pharmaceutical, medical device and medical technology sectors. In-depth coverage of innovation,...

Minze Health NV signed a three-year agreement with Medtronic plc to bring its Minze Diary Pod, an app-controlled automated urine collection device, to markets...

Total biopharma financings rose to $10.79 billion in January 2026, up from $9.08 billion in December. The monthly total nearly matched the January 2024 record...

The U.S. FDA has endorsed ISO 14971 for risk management for medical device manufacturers, but there’s nothing compulsory about industry’s use of this...

Abbott Laboratories made plans to enter the cancer screening market with its reported acquisition of Exact Sciences Corp. The deal will pay Exact Sciences...

Medtronic plc posted solid fiscal year second-quarter results led by the cardiovascular business with 9.3% growth. The Affera Sphere-9 pulsed field ablation...

Harbour Biomed is stepping up its antibody discovery process by using AI to develop innovative therapeutics. “We have done great through the traditional way...

Results of the Shortcut study, presented last week at the Transcatheter Cardiovascular Therapeutics meeting in San Francisco, indicated that cutting balloon...

Shares of Mountain View, Calif.-based Heartflow Inc. have oscillated significantly over the past three months, but the results of a study of the company’s...

Vivace Therapeutics Inc. reported preclinical efficacy data of VT-3989, a TEAD inhibitor, in in vitro and in vivo models of aggressive meningioma. VT-3989 is...

Breaking news and analysis of the global biotechnology, pharmaceutical, medical device and medical technology sectors. In-depth coverage of innovation,...

China’s National Medical Products Administration (NMPA) has issued guidance governing online sales of medical devices with a focus on inspections of the...

Xeltis BV secured €47.5 million in financing to help bring Axess, its vascular access conduit for hemodialysis, to the market. The funds include a venture...

The U.K. Medicines and Health Care Products Regulatory Agency provided an update of its guidance for clinical investigations for medical devices and is...

Breaking news and analysis of the global biotechnology, pharmaceutical, medical device and medical technology sectors. In-depth coverage of innovation,...

Med-tech financing activity rebounded sharply in 2025, with total reported capital raised climbing to $39.55 billion, nearly doubling from $25.35 billion in...

The Advanced Research Projects Agency for Health (ARPA-H) is taking aim at the shortage of medical services with a program designed to foster development of...

Boston Scientific Corp. recently reported new four-year data on its Farapulse pulsed field ablation platform, which demonstrated that patients with paroxysmal...

Affluent Medical SAS is becoming Carvolix after it entered into binding agreements to acquire Caranx Medical SAS for €16.6 million (US$19.34 million) and...

Prognomiq Inc. reported the launch of its Provue Lung, a novel blood-based laboratory developed test designed to help improve detection of lung cancer at its...

Haemonetics Corp. acquired Vivasure Medical Ltd. for €100 million (US$116 million) cash plus up to an additional €85 million (US$99 million) in contingent...

Daily regulatory developments

Biopharmaceutical deals, M&A, financings and FDA approval data from 1999 to present.

The treatment of Pseudomonas aeruginosa infections is significantly challenged by the pathogen’s diverse resistance mechanisms, with biofilm formation being...

Kakao Healthcare Corp. plans to secure ₩100 billion (US$68 million) through two investment deals with Cha Biomedical Group and outside investors by early...