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What changed in biotechnology regulation and policy this week?
Government decisions, new rules and policy shifts reported this week.
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Cari-Anne Quinn, CEO of Life Sciences Hub Wales, discusses the role of health innovation in addressing pressures within the Welsh healthcare system.
Read at gov.uk ↗03
The U.S. Food and Drug Administration (FDA) has extended its review period for Capricor Therapeutics' Duchenne muscular dystrophy (DMD) cell therapy candidate.
Read at fiercebiotech.com ↗04
The US Food and Drug Administration (FDA) has updated its guidance to reduce the allotted time and the number of questions permitted for pre-BLA (Biologics License Application) meetings.
Read at citeline.com ↗05
The U.S. Food and Drug Administration (FDA) has granted approval for Implantica's gastroesophageal reflux disease (GERD) implant.
Read at fiercebiotech.com ↗06
The US Food and Drug Administration (FDA) has placed a clinical hold on Regenxbio's gene therapy candidate RGX-121.
Read at fiercebiotech.com ↗07
Spruce Biosciences has completed key manufacturing requirements following successful discussions with the FDA.
Read at fiercebiotech.com ↗08
The US Food and Drug Administration (FDA) proposed a rule on August 11, 2026, that would make GRAS (Generally Recognized As Safe) notification mandatory for food ingredients.
Read at foodnavigator.com ↗What funding rounds and acquisitions happened in biotechnology this week?
The week’s notable investments, financing rounds, acquisitions and strategic deals.
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AusperBio Therapeutics has secured $120 million in a Series C funding round.
Read at fiercebiotech.com ↗10
BioXcel Therapeutics has filed for bankruptcy and entered into an agreement for Teva Pharmaceutical to acquire its neuroscience portfolio.
Read at fiercebiotech.com ↗11
Crunchbase News reports on the top 10 U.S. startup funding rounds for the week ending August 28, 2026.
Read at crunchbase.com ↗12
The Coalition for Epidemic Preparedness Innovations (CEPI) has committed up to $16.5 million to support the clinical development of an Ebola vaccine candidate developed by the Egyptian biotech company Minapharm.
Read at fiercebiotech.com ↗13
The University of California, San Francisco (UCSF) Quantitative Biosciences Institute (QBI) has been awarded $46 million in grant funding from Aligning Research to Impact Autism (ARIA).
Read at genengnews.com ↗14
McKesson has agreed to acquire Precision Medicine Group for $2.25 billion.
Read at fiercebiotech.com ↗15
Melbourne-based biotech startup ImmunoBiota Therapeutics, founded by Dr. Eliana Marino, is seeking to raise $5 million in a Seed funding round to advance clinical trials for its oral type 1 diabetes treatment, IBT-100.
Read at startupdaily.net ↗16
The UK government has awarded funding to nine projects focused on developing animal-free drug testing technologies.
Read at citeline.com ↗8 of 10 funding and m&a events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.
What products launched in biotechnology this week?
Notable product launches, releases and platform updates from the week.
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The FDA has granted approval to Priovant Therapeutics for its drug Lisraya, intended to treat a rare skin disease.
Read at biopharmadive.com ↗18
Italian startup PlantVoice, founded in 2023 by Matteo Beccatellia and Tommaso Beccatellia, has developed an agronomic platform that integrates real-time plant physiological data with environmental metrics.
Read at tech.eu ↗19
The U.S. Food and Drug Administration has approved a new drug for the treatment of pancreatic cancer.
Read at nytimes.com ↗20
The FDA approved Revolution Medicines' oral therapy Rasonque (daraxonrasib) for the treatment of metastatic pancreatic adenocarcinoma in the United States.
Read at genengnews.com ↗21
On August 26, 2026, the U.S. Food and Drug Administration approved Rasonque (daraxonrasib), a daily pill developed by Revolution Medicines for adults with metastatic pancreatic cancer.
Read at thestreet.com ↗22
The U.S. Food and Drug Administration (FDA) granted expedited approval to the drug daraxonrasib, marketed as Rasonque by Revolution Medicines, for treating metastatic pancreatic cancer.
Read at courthousenews.com ↗23
Maxis AI launched MaxisAI Holarchy, a governed institutional memory layer for life sciences enterprises, on August 26, 2026, in Edison, New Jersey.
Read at hpcwire.com ↗24
On Wednesday, August 26, 2026, the US Food and Drug Administration (FDA) approved Rasonque, a new drug developed by RevMed for the treatment of pancreatic cancer.
Read at semafor.com ↗8 of 14 product launches events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.
What financial results were reported in biotechnology this week?
Earnings, guidance and other financial results reported this week.
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Bank of America initiated coverage of the biotech company Apnimed with a Buy rating and a $41 price objective.
Read at thestreet.com ↗26
The FDA approved three new therapies this week: Priovant Therapeutics' Lisraya for dermatomyositis, Gilead Sciences' Bixlenvo for HIV, and an expanded indication for Eli Lilly's Mounjaro.
Read at pharmexec.com ↗27
Alex Zhavoronkov, the Founder and CEO of Insilico Medicine, discussed the company's financial performance and business outlook on Bloomberg: The China Show on August 27, 2026.
Read at bloomberg.com ↗28
Immatics, a Germany-based biotechnology company, has secured additional financing to support the advancement of its cancer drug pipeline.
Read at citeline.com ↗29
A report by MassBio indicates that seed round and Series A financing trends for Massachusetts biotech startups are diverging.
Read at biopharmadive.com ↗30
The U.S. Food and Drug Administration (FDA) has extended its review period for Capricor Therapeutics' cell therapy candidate, deramiocel, following the submission of an updated application with a refined indication.
Read at biopharmadive.com ↗31
Hansa Biopharma is exploring a potential US stock market listing.
Read at citeline.com ↗What research was published in biotechnology this week?
New research findings and studies published this week.
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Researchers at Boston University’s Center for Regenerative Medicine and Boston Medical Center have developed a scalable method to generate CD4+ helper T cells from induced pluripotent stem cells (iPSCs).
Read at genengnews.com ↗33
Researchers at the Institute for Systems Biology (ISB), led by Jim Heath, have identified that atypical memory B cells are responsible for producing autoantibodies following SARS-CoV-2 infection.
Read at genengnews.com ↗34
A small gene-editing study conducted by researchers has demonstrated that a single-time treatment can significantly reduce LDL cholesterol levels.
Read at nytimes.com ↗35
Researchers at the Chinese Academy of Sciences have developed injectable 'myografts' that form self-contracting muscle structures under the skin.
Read at futurism.com ↗36
A Phase 1 clinical trial at Charité—Universitätsmedizin Berlin involving six patients with severe, treatment-refractory rheumatoid arthritis demonstrated that CD19-CAR T-cell therapy (mivocabtagene autoleucel) significantly reduced disease activity.
Read at genengnews.com ↗37
AstraZeneca and Amgen's drug Tezspire has achieved positive results in a clinical trial for Eosinophilic Esophagitis (EoE).
Read at citeline.com ↗38
Neurosurgeons at the National Hospital for Neurology and Neurosurgery in London performed the world's first successful AI-assisted brain tumour removal in May 2026.
Read at theguardian.com ↗39
Researchers at Southern Illinois University Carbondale have developed 'µBites,' cookies created from polyethylene terephthalate (PET) plastic bottles using engineered microbes and yeasts.
Read at gizmodo.com ↗8 of 28 research events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.
What partnerships were announced in biotechnology this week?
Partnerships, integrations and joint projects announced this week.
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Abu Dhabi-based healthcare company M42 has signed a 10-year contract with the Botswana Ministry of Health to implement a national genomics program and digitize health records.
Read at semafor.com ↗1 of 8 partnerships events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.
What people moved in and out of biotechnology roles this week?
Executive appointments and departures reported this week.
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Cellares, a cell therapy manufacturing company, announced it will lay off 100 employees.
Read at biopharmadive.com ↗1 of 3 people moves events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.
What else happened in biotechnology this week?
Developments from the week that fit none of the other sections.
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An investigation by the Financial Times has identified a growing market for unproven stem cell therapies in the United States.
Read at ft.com ↗43
Biopharmaceutical manufacturers experience batch failures on average every 40 weeks due to factors like contamination, operator error, and equipment failure.
Read at pharmexec.com ↗44
A BioSpace LinkedIn poll indicates that nearly 25% of biopharma professionals unemployed for at least six months have ceased their job searches in 2026.
Read at biospace.com ↗45
The US FDA has approved Johnson & Johnson's drug Imaavy (nipocalimab-aahu) for treating warm autoimmune hemolytic anemia in patients aged 12 and older.
Read at pharmexec.com ↗4 of 17 other developments events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.