01
What changed in biotechnology regulation and policy this week?
Government decisions, new rules and policy shifts reported this week.
02
The European Medicines Agency (EMA) has issued a positive opinion for Incyte's drug Povofortay for the treatment of hidradenitis suppurativa.
Read at citeline.com ↗03
Financial authorities in South Korea tightened delisting requirements for KOSPI and KOSDAQ companies starting in July 2026.
Read at thelec.net ↗04
The U.S. Food and Drug Administration (FDA) granted 510(k) clearance to Aptitude for its next-generation Metrix COVID-19 diagnostic test on September 18, 2026.
Read at fiercebiotech.com ↗05
In June 2026, the FDA launched a pilot program aimed at accelerating early-stage drug trial timelines by integrating real-world data (RWD).
Read at pharmexec.com ↗06
The US Food and Drug Administration (FDA) held a public hearing on September 15, 2026, to discuss safety, access, and administration protocols for potential psychedelic medicines.
Read at fiercehealthcare.com ↗07
The US Food and Drug Administration (FDA) convened a public hearing on September 15, 2026, to discuss the regulatory framework for the potential first approval of a psychedelic medicine.
Read at fiercebiotech.com ↗08
The FDA has approved Scholar Rock's drug Isembyld for the treatment of spinal muscular atrophy (SMA).
Read at biopharmadive.com ↗8 of 16 regulation and policy events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.
What funding rounds and acquisitions happened in biotechnology this week?
The week’s notable investments, financing rounds, acquisitions and strategic deals.
09
Bristol Myers Squibb has terminated its development of a degrader-antibody conjugate asset acquired from Orum Therapeutics for $100 million.
Read at fiercebiotech.com ↗10
The UK government's Sovereign AI Fund is in negotiations to invest in the London-based drug discovery startup Potential Sciences.
Read at sifted.eu ↗11
Venture studio Palomar Labs has spun out its first portfolio company, Ariadne Bio, to develop a non-hallucinogenic serotonin 2A receptor agonist named AB-300.
Read at genengnews.com ↗12
Novo Nordisk has acquired three early-stage obesity drug programs from the New York-based biotech company Kallyope.
Read at fiercebiotech.com ↗13
Electra Therapeutics raised $350 million through an upsized initial public offering on the Nasdaq.
Read at fiercebiotech.com ↗14
Novartis has exercised an option to acquire a brain delivery platform from Sironax for $125 million.
Read at fiercebiotech.com ↗15
GSK has entered into a deal worth up to $750 million with Chimagen Biosciences to develop a trispecific T-cell engager for multiple myeloma.
Read at fiercebiotech.com ↗16
Evvy, a precision medicine company based in the United States, has raised $40 million in a Series B funding round led by Catalio Capital Management.
Read at fiercehealthcare.com ↗8 of 13 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.
17
Goa Therapeutics has emerged from stealth mode on September 17, 2026, with the goal of developing a therapeutic drug designed to rapidly sober up individuals who have consumed excessive alcohol.
Read at fiercebiotech.com ↗18
The FDA has approved Fayuvi, a gene therapy developed by Ultragenyx Pharmaceutical, as the first treatment for Sanfilippo syndrome type A (MPS IIIA).
Read at medcitynews.com ↗19
The U.S. Food and Drug Administration (FDA) has approved Telix Pharmaceuticals' Pixclara, marking the first FET-PET imaging agent for brain cancer.
Read at fiercebiotech.com ↗20
Swedish company Flow Neuroscience has launched its FDA-approved depression treatment headset in the US market.
Read at wired.com ↗21
Cullinan Oncology and Taiho Pharmaceutical are preparing their drug candidate zipalertinib to compete with Johnson & Johnson's Rybrevant in the non-small cell lung cancer (NSCLC) market.
Read at citeline.com ↗22
Michael Polansky, the fiancé of Lady Gaga, has co-founded a biotech company called Outer Bio.
Read at businessinsider.com ↗6 of 7 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.
23
Ultragenyx has set the price for its Sanfilippo syndrome gene therapy at $4 million.
Read at biopharmadive.com ↗24
A biotech company, which held $268 million in cash, announced a 46 percent workforce reduction following a failed drug trial.
Read at inc.com ↗2 of 4 financial results events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.
What research was published in biotechnology this week?
New research findings and studies published this week.
25
Dr. Barbara Bendlin from the University of Wisconsin–Madison and Dr. Federico Ray have conducted over a decade of research into the gut-brain connection.
Read at thestreet.com ↗26
Scientists at Stanford University have successfully implanted human neurons into the brains of mice, creating models where human cells account for nearly half of the brain volume.
Read at futurism.com ↗27
Eli Lilly presented early clinical data at the Psych Congress 2026 in New Orleans on September 18, 2026, regarding its GIP/GLP-1 receptor agonist candidate brenipatide.
Read at genengnews.com ↗28
Anthropic has confirmed the operation of a wet biology lab in San Francisco to conduct physical experiments using its AI models.
Read at techcrunch.com ↗29
Researchers from Stanford Medicine, Caltech, and UCSF have discovered that the human brain develops from two distinct progenitor cells, suggesting it is composed of two independently evolved organs.
Read at genengnews.com ↗30
The Advanced Research Projects Agency for Health (ARPA-H) launched the SPECTRA program on September 17, 2026, to improve autism diagnosis and precision care.
Read at fiercehealthcare.com ↗31
A 3-year-old boy with metastatic hepatoblastoma in Texas achieved complete remission after receiving experimental CAR T cell therapy targeting glypican-3.
Read at gizmodo.com ↗32
At the WCLC 2026 conference held in September 2026, clinical trial results demonstrated that the drug Ivonescimab achieved a superior overall survival (OS) outcome compared to Keytruda in first-line (1L) non-small cell lung cancer (NSCLC) patients with high PD-L1 expression.
Read at citeline.com ↗8 of 39 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.
33
Roche has entered into a partnership with Dualitis to develop novel bispecific antibodies targeting immunology and inflammation (I&I) indications.
Read at citeline.com ↗34
Danish pharmaceutical company Novo Nordisk has announced a partnership with AI firm Anthropic to accelerate drug discovery.
Read at semafor.com ↗35
Molecular Devices and STEMCELL Technologies have launched a validated automated workflow for human intestinal organoid culture using the CellXpress.ai system and IntestiCult Plus medium.
Read at genengnews.com ↗36
Novo Nordisk and Anthropic have entered into a strategic alliance to utilize Anthropic's Claude large language models for drug discovery.
Read at citeline.com ↗37
Novo Nordisk and Anthropic announced a strategic partnership on September 16, 2026, to integrate AI into drug discovery and software development workflows.
Read at pharmexec.com ↗38
Cellares and GenomeFrontier Therapeutics have entered a partnership to evaluate the automated manufacturing of the investigational CAR T-cell therapy GF-CART01 using the Cellares Cell Shuttle platform.
Read at genengnews.com ↗39
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) and Malaysian health officials held high-level discussions in Kuala Lumpur on September 15, 2026.
Read at gov.uk ↗7 of 13 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.
40
Wendy Short Bartie, formerly a senior vice president at Bristol Myers Squibb, transitioned to the role of executive vice president and chief corporate affairs officer in June 2025.
Read at pharmexec.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.
41
Novo Nordisk has rebranded as 'Novo' and introduced a new cultural framework, 'The Novo Way,' under CEO Mike Doustdar.
Read at pharmexec.com ↗42
Kevin Davies has authored a new book titled 'Curved Air' published by Harvard University Press, which explores the history and treatment of sickle cell disease.
Read at genengnews.com ↗43
Roivant Sciences, led by CEO Matt Gline, is transitioning from a drug pipeline-focused company to a commercial-stage entity.
Read at citeline.com ↗44
MIT Technology Review hosted a live roundtable event on September 16, 2026, featuring Will Douglas Heaven and Grace Huckins to discuss existential risks posed by artificial intelligence.
Read at technologyreview.com ↗45
BioSpace data indicates that biopharma job postings in the United States rose by 17% between January and August 2026.
Read at biospace.com ↗5 of 15 other developments events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.