Avalyn Pharma found strong investor interest in its inhalable drugs in development for two types of pulmonary fibrosis, enabling the company to upsize its IPO. Data from two mid-stage studies are expected in 2027.

The post Avalyn Pharma Takes a Breath to Raise $300M in IPO Cash for Lung Drug Trials appeared first on MedCity News.

Coultreon Biopharma’s lead drug candidate, acquired from Galapagos, is a small molecule designed to selectively inhibit a novel immunology target called SIK3. The Series A financing will support Phase 2 clinical trials in psoriasis and ulcerative colitis.

The post Immunology-Focused Coultreon Adds $125M for Pills That Pack the Punch of Injectable Biologics appeared first on MedCity News.

The World Health Organization has prequalified Coartem Baby, the first and only antimalarial for babies. Novartis developed this combination drug in partnership with Medicines for Malaria Venture.

The post Novartis Antimalarial Clears Key WHO Review to Get the Combo Drug to Babies appeared first on MedCity News.

Kurma Partners’ new fund is the venture capital firm’s fourth and largest. Previous Kurma investments have led to exits that include the acquisitions of Corlieve Therapeutics, Emergence Therapeutics, and Amolyt Pharma.

The post VC Firm Kurma Partners Closes €215M Fund in Pursuit of ‘Disruptive Therapeutic Solutions’ appeared first on MedCity News.

As radiopharmaceuticals continue to evolve, the convergence of scientific innovation, operational practicality, and clinical expertise is opening new possibilities in oncology.

The post Precision Delivered: How Radiopharmaceuticals Are Reshaping Cancer Care appeared first on MedCity News.

Merck’s HIV drug Idvynso could become a drug choice for patients who need to switch from Gilead Sciences’ Biktarvy for safety or tolerability reasons. The Merck combination drug pairs two molecules that bring different mechanisms of action to suppressing HIV.

The post FDA Nod for Merck HIV Drug Brings Competition to a Gilead Sciences Antiretroviral appeared first on MedCity News.

Tortugas Neurosciences’ two lead programs are in-licensed oral small molecules in development for schizophrenia and tinnitus. The startup is led by veterans of Sage Therapeutics, a neuroscience biotech that was acquired last year.

The post Neuro Startup Tortugas Unveils $106M and a Pipeline of Drugs for the Brain appeared first on MedCity News.

Himanshu Shah, an activist investor and large shareholder of Novavax, whose stock has plummeted over the years, believes the company should cut costs more aggressively, reduce the size of its board, and do more to prop up its financial performance. But are the criticisms valid?

The post Is Shah Capital’s Criticism of Novavax Fair? A Wall Street Analyst Weighs In appeared first on MedCity News.

Obsidian Therapeutics aims to show its TIL cell therapy has advantages over an Iovance Biotherapeutics TIL therapy marketed for treating melanoma. Obsidian’s merger with Galera Therapeutics will give it a public listing and a private placement to support clinical development of the combined company’s cancer drug pipeline.

The post Obsidian, Galera Merger Comes With $350M Infusion for Cancer Drug Trials appeared first on MedCity News.

Eli Lilly is paying up to $300 million for CrossBridge Bio, a startup developing antibody drug conjugates that deliver two drug payloads to cancers. Beyond potentially better efficacy, CrossBio’s dual approach could also fight drug resistance.

The post Eli Lilly Buys Startup CrossBridge Bio to Bring a More Powerful Strike to Tumors appeared first on MedCity News.

To address the clinical burden and enhance R&D, companies are turning to virtual solutions. This involves synthetic data, digital twin models, and AI to speed analysis.

The post Why Synthetic Data is the Antidote to Clinical Trials appeared first on MedCity News.

Sidewinder Therapeutics and Stipple Bio each raised mega-rounds of financing to support their approaches to improving the targeting abilities of antibody drug conjugates for cancer. Both startups are on track to enter the clinic next year.

The post Two New Takes on Making a Type of Targeted Cancer Therapy Even Better appeared first on MedCity News.

Gilead Sciences exercised its option to license a Kymera Therapeutics’ protein-degrading drug designed to eliminate the cancer-driving protein CDK2. Meanwhile, Roche’s new partnership with C4 Therapeutics is focused on developing degrader antibody drug conjugates for undisclosed cancer targets.

The post Gilead and Roche Bet on Protein Degraders for Their Cancer Drug Pipelines appeared first on MedCity News.

Insmed drug Brinsupri failed to beat a placebo in a mid-stage clinical trial testing the daily pill as a treatment for hidradenitis suppurativa, a chronic inflammatory skin disorder. Brinsupri is still projected to become a blockbuster seller in non-cystic fibrosis bronchiectasis, where it is the first approved therapy for this chronic lung condition.

The post Trial Failure in the Skin Does Not Dent Insmed Drug’s Potential in the Lungs appeared first on MedCity News.

Consumers are inundated with false information circulating online about GLP-1 medicines, which causes confusion and can lead to potentially serious health problems resulting from dosing errors and adverse reactions to ingredients in compounded GLP-1 products.

The post It’s Time to Put Guardrails on GLP-1 Compounding appeared first on MedCity News.

Soleno Therapeutics brings Neurocrine Biosciences Vykat XR, a drug commercialized for treating the rare genetic disease Prader-Willi syndrome. This blockbuster prospect complements Crenessity, a Neurocrine drug approved for treating a rare endocrine disorder called congenital adrenal hyperplasia.

The post Neurocrine’s $2.9B Soleno Buyout Brings What Could Become Its Next Blockbuster Drug appeared first on MedCity News.

Biogen’s Apellis Pharmaceuticals acquisition comes nearly two years after the drugmaker purchased immunology startup Human Immunology Biosciences. CEO Chris Viehbacher said Apellis accelerates Biogen’s expansion in nephrology, supporting a HI-Bio drug currently in pivotal testing for three kidney conditions.

The post Why Biogen Is Paying $5.6B to Buy Apellis Pharma appeared first on MedCity News.

More therapeutic options times more data per option times the same number of clinical hours equals something that breaks. The practices that will thrive when the next wave of longevity therapeutics arrives are the ones that have already solved this.

The post AI Drug Discovery Is Reshaping Longevity Medicine. Is Your Practice Ready? appeared first on MedCity News.

Centessa Pharmaceuticals’ cleminorexton is part of the orexin agonist drug class, which could introduce a new approach to the treatment of narcolepsy and other sleep disorders. Acquiring Centessa brings Eli Lilly into a group of clinical-stage orexin agonist drug developers that includes Takeda Pharmaceutical, Alkermes, and Eisai.

The post Eli Lilly’s Neuro Prospects Expand to Sleep Science With $6.3B Centessa Acquisition appeared first on MedCity News.

Kailera Therapeutics’ planned IPO will fund ongoing clinical development of a pipeline led by a drug that could rival Eli Lilly’s Zepbound in both efficacy and tolerability. Meanwhile, Renaissance Capital’s recap of first quarter 2026 IPOs shows slowing activity amid market turbulence from tariffs and war.

The post Kailera Plans IPO for Obesity Drug That Could Top Lilly’s Zepbound appeared first on MedCity News.

Fujifilm went from being the no. 1 camera film company to seeing sales tumble as consumers switched to digital cameras. Lars Petersen, CEO of the company’s biotechnologies business, explains how the company pivoted to becoming a partner of the life sciences industry.

The post MedCity Pivot Podcast: How Fujifilm Tackled An Existential Crisis appeared first on MedCity News.

Rocket Pharmaceuticals received FDA approval for Kresladi, a gene therapy developed to treat leukocyte-adhesion deficiency type 1, an inherited immunodeficiency that can become fatal to infants and young children. Kresladi is the first gene therapy for this ultra-rare disease and the first commercial product for Rocket.

The post FDA Approval Makes Rocket Pharma Gene Therapy the First for Ultra-Rare Immune Disorder appeared first on MedCity News.

Denali Therapeutics’ Avlayah received FDA approval for treating Hunter syndrome, a rare neurological disorder. The biologic medicine uses Denali’s proprietary drug delivery technology to cross the protective blood-brain barrier.

The post FDA Approval for Denali Therapeutics Blazes a New Trail for Brain-Penetrating Drugs appeared first on MedCity News.

We don’t have a shortage of willing patients — instead we have a shortage of scalable ways to identify and engage them responsibly. AI, used meaningfully offers a reliable path forward.

The post AI Won’t Replace Clinical Trial Teams, But It Fixes the Bottlenecks That Keep Patients Out appeared first on MedCity News.

Here are four perspectives from providers, patients, life science executives and healthcare technologists about ways to boost trust at a time of rapid AI deployments.

The post How to Boost Trust in Tech? 4 Perspectives from SXSW appeared first on MedCity News.

Aldeyra said the FDA did not ask for another clinical trial for reproxalap in dry eye disease, but there is a “lack of substantial evidence” that warrants exploration about the reasons for trial failures to identify the appropriate patients for the eye drop. AbbVie holds an option to collaborate on reproxalab’s commercialization.

The post Lacking Evidence, FDA Rejects Aldeyra Dry Eye Disease Drug appeared first on MedCity News.

At SXSW, two FDA observers said stability is returning to the agency after painful DOGE personnel cuts last year, though it’s not equal across divisions. And now, AI tools are being adopted across the board to improve efficiency.

The post Which FDA Division Has the Most Stability As AI Tools Get Adopted Across the Agency? appeared first on MedCity News.

Every life sciences organization needs to consider how best to apply machine learning (ML) to RWE to support better patient outcomes. Here’s how they can ensure RWE is “ML-ready.”

The post Real-World Evidence Meets Machine Learning: What It Takes to Future-Proof Evidence Generation appeared first on MedCity News.

Leucovorin is now approved for cerebral folate deficiency months after FDA Commissioner Marty Makary claimed the decades-old generic drug had promise for treating autism. The FDA’s review was based on published literature and real-world evidence.

The post FDA Drug Approval Marks a First for a Disease — But It’s Not Autism appeared first on MedCity News.

Congress has already granted the FDA flexibility in evaluating therapies for rare diseases, including the use of real-world evidence and natural history data when traditional large-scale trials are not feasible. The question before the FDA now is not if those tools can be applied – they can – but if the agency has the courage to use them before more patients lose their autonomy, and ultimately, their lives, to rare disease.

The post The Lethal Cost of Regulatory Perfection in Rare Disease appeared first on MedCity News.