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FDA Drug Approval Decisions

FDA Drug Approval Decisions

Last updated 31 July 2026. Covering target action dates from August to December 2026. The closing stretch of the third quarter has become the busiest regulatory window of 2026. Between early August and the end of September, the US Food and Drug Administration faces...

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Clinical Trials Roundup | 31 July 2026

Clinical Trials Roundup | 31 July 2026

An FDA advisory committee votes against Capricor Therapeutics' deramiocel in Duchenne muscular dystrophy cardiomyopathy, Pfizer's ritlecitinib meets its co-primary endpoints in two Phase 3 nonsegmental vitiligo trials, Karyopharm Therapeutics' selinexor misses its...

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The Security Blind Spot in Life Science Digitalization

The Security Blind Spot in Life Science Digitalization

The life sciences sector is in the midst of a digital transformation that most security teams were not built to handle. AI-driven drug discovery platforms, cloud-connected lab equipment, genomic databases, and real-time patient data pipelines are creating attack...

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Why Biopharma Must Invest in Novel Targets

Why Biopharma Must Invest in Novel Targets

Drug development continues to concentrate on a small set of well-known targets, creating a crowded landscape where many companies pursue similar pathways. While research into novel mechanisms continues, familiar targets often take priority, reflecting a cautious...

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Weekly News Roundup | 18 May 2026

Weekly News Roundup | 18 May 2026

Life science news 18 May 2026: FDA leadership turmoil, a landmark Alzheimer's breakthrough and a $15 billion China licensing deal define a historic week for the global industry. The week of 10 to 17 May 2026 delivered a concentration of high-impact events across...

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Biologics on the Brink: The Patent Cliff Facing Big Pharma

Biologics on the Brink: The Patent Cliff Facing Big Pharma

The global pharmaceutical industry is approaching what many analysts are calling the largest patent cliff biologics in its history. This pharma patent cliff biologics analysts have long anticipated is now arriving in force. Between 2025 and 2030, drugs collectively...

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Clinical Trials Roundup | 15 May 2026

Clinical Trials Roundup | 15 May 2026

AstraZeneca's eneboparatide meets the Phase 3 CALYPSO primary endpoint in chronic hypoparathyroidism with full data presented at the European Congress of Endocrinology, Alkermes' LUMRYZ meets its primary endpoint in the Phase 3 REVITALYZ trial for idiopathic...

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Beyond GLP-1: The Future of Obesity Care is Hybrid

Beyond GLP-1: The Future of Obesity Care is Hybrid

The emergence of GLP-1 receptor agonists has fundamentally reshaped obesity treatment. For the first time, we are seeing consistent, clinically meaningful weight loss at scale, supported by robust clinical programs such as STEP and SURMOUNT (Wilding et al., 2021;...

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Why Biopharma Must Invest in Novel Targets

Why Biopharma Must Invest in Novel Targets

Drug development continues to concentrate on a small set of well-known targets, creating a crowded landscape where many companies pursue similar pathways. While research into novel mechanisms continues, familiar targets often take priority, reflecting a cautious...

read more
Weekly News Roundup | 18 May 2026

Weekly News Roundup | 18 May 2026

Life science news 18 May 2026: FDA leadership turmoil, a landmark Alzheimer's breakthrough and a $15 billion China licensing deal define a historic week for the global industry. The week of 10 to 17 May 2026 delivered a concentration of high-impact events across...

read more
Biologics on the Brink: The Patent Cliff Facing Big Pharma

Biologics on the Brink: The Patent Cliff Facing Big Pharma

The global pharmaceutical industry is approaching what many analysts are calling the largest patent cliff biologics in its history. This pharma patent cliff biologics analysts have long anticipated is now arriving in force. Between 2025 and 2030, drugs collectively...

read more
Clinical Trials Roundup | 15 May 2026

Clinical Trials Roundup | 15 May 2026

AstraZeneca's eneboparatide meets the Phase 3 CALYPSO primary endpoint in chronic hypoparathyroidism with full data presented at the European Congress of Endocrinology, Alkermes' LUMRYZ meets its primary endpoint in the Phase 3 REVITALYZ trial for idiopathic...

read more
Beyond GLP-1: The Future of Obesity Care is Hybrid

Beyond GLP-1: The Future of Obesity Care is Hybrid

The emergence of GLP-1 receptor agonists has fundamentally reshaped obesity treatment. For the first time, we are seeing consistent, clinically meaningful weight loss at scale, supported by robust clinical programs such as STEP and SURMOUNT (Wilding et al., 2021;...

read more

Featured Articles

FDA building exterior alongside pharmaceutical laboratory setting representing drug approval decisions

FDA Drug Approval Decisions

Last updated 31 July 2026. Covering target action dates from August to December 2026. The closing stretch of the third quarter has become the busiest regulatory window of 2026. Between early August and the end of September, the US Food and Drug Administration faces...
Pipette dispensing into lab vials with glowing DNA helix and genetic sequence data for Life Science Daily News

Life Science Daily News: Eight Months of Growth and a Global Community Taking Shape

Life Science Daily News launched in November 2025 with a simple premise: that researchers, biotech founders, healthcare professionals, communications specialists and industry professionals should be able to publish their own work directly to a specialist audience,...
gloved hands holding a glowing blue sample vial (labelled LOT: 24-B1, SAMPLE: GENO-) with a lab researcher working in the background.

CRISPR Gene Editing 2026: Rare Diseases, Cancer and Autoimmune

CRISPR gene editing in 2026 is no longer a technology to watch. It is a technology delivering results. Across three distinct disease areas, rare inherited conditions, haematologic and solid cancers, and autoimmune disease, clinical programmes are accumulating...
Three GLP-1 drug pipeline injection pens and oral tablets beside a clinical trial efficacy chart on a clipboard

The GLP-1 Drug Pipeline: Every Candidate to Watch in 2026

The GLP-1 drug pipeline has become one of the most consequential and closely watched in modern pharmaceutical history. In 2026, the class of glucagon-like peptide-1 receptor agonists is no longer defined solely by Ozempic and Wegovy. A new generation of oral tablets,...
Sjögren's disease diagnosis: close-up of a dry, irritated eye with eye drops being applied

Anti-Ro52 vs Anti-Ro60: Advancing Sjögren’s Disease Diagnosis

Autoantibody testing is a central part of autoimmune disease diagnosis, including Sjögren’s disease (SjD). The American College of Rheumatology and European Alliance of Associations of Rheumatology (ACR/EULAR) classification criteria for SjD incorporate ocular and...

Further News

Weekly News Roundup | 11 May 2026

Weekly News Roundup | 11 May 2026

Life science news 11 May 2026: M&A momentum, artificial intelligence diagnostics and a record week for deal-making define an active seven days for the global life science industry. The week of 4 to 10 May 2026 produced a dense cluster of major acquisitions, a...

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Orforglipron Approved: Inside the Oral GLP-1 Race

Orforglipron Approved: Inside the Oral GLP-1 Race

The obesity treatment landscape shifted decisively on 1 April 2026, when the US Food and Drug Administration approved Foundayo (orforglipron), an oral once-daily glucagon-like peptide-1 (GLP-1) receptor agonist developed by Eli Lilly. The decision marks the arrival of...

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Clinical Trials Roundup | 8 May 2026

Clinical Trials Roundup | 8 May 2026

Cytokinetics’ aficamten meets dual primary endpoints in the pivotal Phase 3 ACACIA-HCM trial for non-obstructive hypertrophic cardiomyopathy, Axsome Therapeutics secures FDA approval of AUVELITY as the first non-antipsychotic treatment for Alzheimer’s disease...

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GSK Secures $1bn Rights to SiranBio siRNA Therapy

GSK Secures $1bn Rights to SiranBio siRNA Therapy

GSK has entered into an exclusive licensing agreement with Chinese biotech Suzhou Siran Biotechnology (SiranBio), securing global rights to the company's early-stage small interfering RNA (siRNA) therapy, SA030, in a deal worth up to $1.005 billion in potential...

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Paediatric Trials: Why Children Remain Therapeutic Orphans

Paediatric Trials: Why Children Remain Therapeutic Orphans

Children have long been described as therapeutic orphans. It is a term first used by the American paediatrician Harry Shirkey of the Children’s Hospital in Birmingham, Alabama, at a 1963 conference and formally published in 1968. Despite more than five decades of...

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Further News

Atacicept FDA Approval: Trutakna Cleared for IgAN

The atacicept FDA approval that the nephrology community had been anticipating since January arrived on schedule on 7 July 2026, when the US Food and Drug Administration granted accelerated approval to Vera Therapeutics' atacicept-vymj, to be marketed as Trutakna, for...

AI Trust in Healthcare Starts with the People in the Room

Healthcare is on an accelerated path to digitisation, creating real opportunity to reduce administrative burden, improve risk detection, support prioritisation, and help people access the right care sooner. But without deliberate design, these same systems risk...

The Regulatory Window for AI in Pharmacovigilance Is Open

In more than two decades of working with global CROs, pharmaceutical companies, and biotech organizations, I have watched pharmacovigilance teams absorb wave after wave of increasing complexity. More products on the market. More data sources to monitor. More...

Webinar: Decoding Neurodegeneration via iPSC-Derived Human Brain Models

The human brain presents an intricate evolutionary paradox. While its sophisticated neural networks govern complex cognition, its architecture is uniquely susceptible to progressive degradation. For decades, the biomedical community has grappled with an uncomfortable...

Why the Immune System Is Becoming the New Battlefield in Cancer Care

The Old Paradigm For more than a century, cancer treatment has been defined by a straightforward objective: find the tumor and destroy it. Surgery removes it, radiation damages it. Chemotherapy attacks rapidly dividing cells. These approaches have saved countless...

CE Marking Is Not Enough: Three Layers for Connected Medical Devices

If your device connects to a network and runs AI, CE marking under MDR or IVDR is only the first layer for connected medical devices. Two further EU frameworks, the AI Act and the Cyber Resilience Act, can also apply, each with obligations that go beyond what MDR...

When Months Become Days: AI’s Edge in Patient Engagement

Every therapy that reaches a patient first has to clear a quieter hurdle that rarely makes headlines: finding enough of the right people to test it. That hurdle is where most clinical programs stumble. Roughly 80% of clinical trials fail to meet their enrollment...

What My Stroke Recovery Taught Me About Mobility and Safer Care

After more than three decades in nursing, I have had the privilege of caring for patients during some of the most vulnerable moments of their lives. I have worked alongside extraordinary nurses, therapists, physicians, and support staff who dedicate themselves to...

Tregzi (Orca Bio): Inside the First Regulatory T-Cell Therapy for Blood Cancer

The US Food and Drug Administration has approved Tregzi, a regulatory T-cell therapy developed by Orca Bio. It is the first treatment built from highly purified regulatory T cells to reach the American market. The FDA cleared Tregzi on 30 June 2026. It is designed to...

Workforce Capability Standardization in Medical Affairs

For decades, the pharmaceutical industry has invested heavily in scientific innovation, regulatory rigor, clinical development, manufacturing quality, and commercial excellence. Yet one of the most important links between innovation and patient impact has remained...

Weekly News Roundup | 06 July 2026

Life science news 6 July 2026: the FDA expands the world’s first CRISPR gene therapy to children as young as two, Ipsen commits up to $1.75 billion for a late-stage blood cancer drug, and two first-in-class FDA approvals reshape the cell therapy landscape in a busy...

Atacicept IgA Nephropathy: FDA Decision Due 7 July

Four days from now, the US Food and Drug Administration is due to hand down its atacicept IgA nephropathy decision, ruling on whether the experimental Vera Therapeutics drug becomes the first therapy to target both BAFF and APRIL in adults with the disease. The...

Want to Be Part of the Next Chapter in Life Sciences Media?

 

LifeScienceDaily.news is building a new kind of platform where innovators, researchers, and industry leaders tell their own stories and shape the narrative of what’s next in life sciences. Share your story and lead the conversation.

 

 

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See More Articles

Want to Be Part of the Next Chapter in Life Sciences Media?

 

LifeScienceDaily.news is building a new kind of platform where innovators, researchers, and industry leaders tell their own stories and shape the narrative of what’s next in life sciences. Share your story and lead the conversation.

 

 

Don’t wait for the media to pick up your story. Be the media.