Pharmaceutical industry news

Indonesia’s BPOM Visits Daewoong Pharmaceutical’s Magok R&D Center to Expand Regulatory Cooperation

FDA orders immediate recall of Arcan Bitters over drug adulteration

Robotics & AI in Pharmaceutical Manufacturing

Eisai and Biogen Announce China Approval of LEQEMBI SC-AI for Initiation Treatment of Early Alzheimer’s Disease

FDA outbreak table is showing 17 active investigations

LEQEMBI® (lecanemab) Subcutaneous Formulation as an Initiation Treatment for Early Alzheimer’s Disease Approved in China

America’s New Drug Dealers Have Moved from Street Corners to the Internet – and the FDA is Letting Them

B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container Due to the Presence of Particulate Matter

FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is volunta...

Spinal Cord Stimulator Recall: Boston Scientific Removes Infinion CX Lead

Infinion CX Lead bodies may experience mechanical stress at the anchor site resulting in inadequate...

Monitoring System Correction: GE HealthCare Updates Use Instructions for Portrait Core Services Software

Patients monitored on Portrait Mobile devices may be discharged (removed) from the Portrait monitori...

Early Alert: Heart Pump Controller Purge Cassette Issue from Abiomed

Abiomed is removing Automated Impella Controllers due to purge cassette recognition failures that ma...

Early Alert: Breathing Circuit Issue from Draeger

Removal of VentStar Resus Neo hoses due to the potential for cracks resulting in restricted ventilat...

Israeli ag-biotech company to set up North American HQ in Indiana

Russian Far East universities and pharma group partner on marine‑based biotech

Brandon Capital’s $60m taypayer-funded biotech bets

[SHINSA]English Translation of Review Report: Akuugo (Partial Change Approval)

[SHINSA]Points to Consider for the Evaluation of the Effects of Food on the Pharmacokinetics of Oral Drug Products (Early Consideration) posted.

Ivonescimab Monotherapy Demonstrates Statistically Significant Overall Survival Benefit Compared to Pembrolizumab Monotherapy in PD-L1-Positive Advanced NSCLC in HARMONi-2 Study Conducted by Akeso in China

OncoSil pursues a reimbursement pathway as it prepares for US rollout

China Biotech Services Enters Cooperation Agreement

Onconic Therapeutics wins South Korea approval to begin phase 3 H. pylori trial - CHOSUNBIZ

¿Un túnel que cruce el Estrecho de Magallanes? Académicos UC evaluarán su factibilidad

AbbVie filed Form 8-K

"E-walleting the sun": Challenges of affordability and justice for South Africa’s energy transition

Agency Information Collection Request. 30-Day Public Comment Request

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secreta...

Determination That PHENAPHEN WITH CODEINE NO. 3 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 30 Milligrams, and PHENAPHEN WITH CODEINE NO. 4 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety

The Food and Drug Administration (FDA or Agency) has determined that PHENAPHEN WITH CODEINE NO. 3 (a...

Emergency Use Authorization Declaration

The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of t...

National Institute of Mental Health; Notice of Meeting

Drug label update: unspecified product

Official structured record identifier: 112f1002-c007-4363-ade6-8dfbc61f4b64.

Dopaminergic therapy selectively amplifies hallucination susceptibility in patients with Parkinson’s disease with cortico-striatal hyperconnectivity

QFR-guided versus IVUS-guided with QFR confirmation for drug-coated balloon treatment of non-complex coronary lesions: a single-centre pilot randomised trial

May 2025 therapeutic delivery: industry update

PrEgabalin for Treatment Resistant generalised Anxiety disorder (PETRA): study protocol for a double-blind randomised controlled trial set in the UK.

Counterintuitive: reducing regression-to-the-mean worsens efficiency in simulated clinical trials.

First-in-Human Phase I Trial of HRS-2129, a Selective Nav1.8 Inhibitor: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Subjects.

Assessment: An Unresolved Intercurrent Event in a Randomized Trial of Ciprofol versus Propofol [Response to Letter].

Ultrasound-Guided Infraspinatus-Teres Minor Interfascial Block versus Interscalene Brachial Plexus Block for Analgesia After Arthroscopic Shoulder Surgery: A Randomized Non-Inferiority Clinical Trial.

Corrigendum to "Brief mindfulness intervention for adults with cannabis use disorder: A randomised clinical trial" [Drug Alcohol Depend. 277 (2025) 112909].

Adaptive imatinib regimens can mitigate cumulative toxicity while sustaining hemodynamic benefit: A model-based simulation of the positioning imatinib for pulmonary arterial hypertension trial.

Pharmacokinetic properties of the clinical drug candidate PRI-002 with regard to genotype, sex, age, dose-dependence and food effects in mice.

Bicistronic CD19/CD22 CAR T-Cell Therapy in Pediatric B-Cell Acute Lymphoblastic Leukemia: A Nonrandomized Clinical Trial.

Nanotherapeutics in osteosarcoma: Advances in miRNA nanocarriers and targeted drug delivery.

Effect of operator experience level on clinical outcomes of indirect- and direct-bonding techniques: A single-center, open-label, quasi-randomized controlled clinical trial.

Comparative efficacy and safety of pharmacokinetically guided and body surface area-based 5-fluorouracil dosing in colorectal cancer: a systematic review and meta-analysis.

Symptom Control Proportion Using Patient-Reported Outcomes by Palliative Care Teams as Indicators for the Fourth Basic Plan for Promotion of Cancer Control in Japan.

Association of PR Interval with Illness Duration and Lymphocyte Count in Asian Adults with Bipolar Disorder

Hydrogen Peroxide–Driven Electrophysiological Remodeling: ROS-Mediated Voltage-Gated Ion Channel Expression and Digital Twin Modeling of Malignant Transformation

Therapy challenges and child cohorts: Where the need to treat is the only option

Sleep apnea–hypopnea in children: Evidence that Lize Tongqi decoction with acupuncture, moxibustion, and Xinwu acupoint stimulation is superior to standard Western treatment using montelucast/mometasone furoate

Pharmacotherapy of heart failure: Impact of the 2021 guideline update on guideline-directed medical therapy assessed using a Japanese employee health insurance claims database

Effect of operator experience level on clinical outcomes of indirect- and direct-bonding techniques: A single-center, open-label, quasi-randomized controlled clinical trial

Bioimpedance: From Body Composition Assessment to Emerging Technologies in Clinical Nutrition

Transcranial Direct Current Stimulation in Anorexia Nervosa: A Randomized Sham-Controlled Trial

A Cumulative Electrical Risk Score Is Associated with Appropriate ICD Therapy in Primary-Prevention Patients with Reduced Ejection Fraction: A Single-Center Retrospective Study

Clinical Significance of Maternal Anti-D Antibody Titers in Severe RhD Alloimmunization Requiring Intrauterine Transfusion: A Tertiary Referral Center Experience

Limited Predictability of Traumatic Intracranial Hemorrhage from Routine Pre-CT Clinical Variables in Older Adults with Low-Energy Falls: A Systematic Benchmarking Study in a Retrospective Bicentric Cohort

Clinical Assessment of Obesity Beyond Body Mass Index: Adiposity Evaluation, Body-Composition Phenotyping and Disease Staging: A Narrative Review

Co-Directional Chromosomal Clustering of Metabolic Pathway Genes as a Layout Prior for Synthetic Construct Design

Fenofibrate in ophthalmology: therapeutic efficacy and mechanisms

Validation of a commercial intraoral auto-segmentation algorithm against expert-annotated clinical data with comparison to a transparent algorithm