Scholar Rock SMA drug rejected by FDA over manufacturing concerns

The denial sets back a drug Scholar Rock hopes to become part of a new standard of care for spinal muscular atrophy, treatment for which has changed dramatically over the last decade.

By Ben Fidler • Sept. 23, 2025

FDA clears under-the-skin Keytruda; MBX shares double on study data

The clearance of Keytruda QLEX follows similar approvals for Bristol Myers and Roche. Elsewhere, MBX’s parathyroidism drug impressed investors and Roche claimed success in a breast cancer study.

By Ben Fidler • Sept. 23, 2025

Explore the Trendline➔

Emerging biotech

New biotechs continue to emerge despite a challenging market environment that has forced venture firms to build their drug startups more cautiously.

By BioPharma Dive staff

Why Xoma, a drug royalty firm, is hunting biotech ‘zombies’

The collapse in value of many biotechs over the past few years has created an opportunity for specialists like Xoma to “do the right thing” for the ecosystem and liquidate them, its executives say.

By Gwendolyn Wu • Sept. 23, 2025

MapLight lines up an IPO in bid to challenge Bristol Myers schizophrenia drug

The company, which is developing a competitor to Cobenfy, aims to become one of rare biotechs to price a large IPO of late.

By Gwendolyn Wu • Sept. 22, 2025

Pfizer buys back into obesity drug chase with $4.9B Metsera deal

The deal ends a short run as a publicly traded company for Metsera, which is being sold for more than double its IPO price amid enthusiasm for its weight loss medicines.

By Jonathan Gardner • Sept. 22, 2025

Arvinas reboots, cuts more staff; Porges joins Lazard

Pfizer and Arvinas plan to out-license their partnered drug vepdegestrant. Elsewhere, Novo shared more data for oral Wegovy and Vertex reached a deal in Italy for coverage of its gene editing medicine Casgevy. 

By BioPharma Dive staff • Sept. 19, 2025

A new biotech venture firm emerges, led by Bob Langer’s son

T.Rx Capital was co-founded by Michael Langer, former Pear Therapeutics CEO Corey McCann and Eli Lilly veteran Kwesi Frimpong-Boateng, and raised just shy of $80 million for its first fund.

By Gwendolyn Wu • Sept. 18, 2025

Roivant pill succeeds in rare inflammatory disease trial

A drug licensed from Pfizer will be submitted to the FDA next year after study results showed it reduced dermatomyositis symptoms and steroid use.

By Jonathan Gardner • Sept. 17, 2025

Lilly, Novo showcase new obesity drug data; Fasenra falls short in COPD

Lilly claimed success in a head-to-head trial of oral GLP-1 drugs. Elsewhere, Novo planned a new weight loss trial and an AI-focused startup raised its second “megaround.”

By BioPharma Dive staff • Sept. 17, 2025

Ollin debuts with $100M and plans to challenge top-selling eye drugs

Backed by a trio of top venture firms, Ollin is working on a pair of medicines it believes can one-up Roche’s Vabysmo and Amgen’s Tepezza.

By Gwendolyn Wu • Sept. 17, 2025

Former CinCor execs reunite to helm new biotech startup

Led by former founders of a biotech AstraZeneca acquired in 2023, AllRock Bio is starting out with a drug licensed from Sanofi that’ll be tested against pulmonary arterial hypertension.

By Gwendolyn Wu • Sept. 16, 2025

ATyr shares plunge on trial miss in inflammatory lung disease

The company’s market value was largely wiped out after a therapy it’s been developing for pulmonary sarcoidosis missed its main study goal.

By Jonathan Gardner • Sept. 15, 2025

Novartis dives deeper into protein degraders with second Monte Rosa deal

The company’s new partnership with the "molecular glue” drug developer is broad, focused on immunology and could be worth up to $5.7 billion.

By Ben Fidler • Sept. 15, 2025

Foundation models are medtech’s newest trend. But what are they?

The AI models, which are built on massive datasets and can be adapted to multiple tasks, have become a part of medtech companies’ lexicon in the past few years.

By Elise Reuter • Sept. 15, 2025

Reaching more patients: How AI and data drive better representation in clinical trials

New AI tools are finally helping medical researchers include the diverse patients they've missed for decades.

Sept. 15, 2025

Takeda poaches top Lilly exec; Maze soars on early PKU drug data

Rhonda Pacheco, who oversaw Zepbound’s launch, will run Takeda’s U.S. business. Elsewhere, early data suggested Maze might have a “best-in-class” rare disease drug and Arrowhead challenged Ionis in court.

By BioPharma Dive staff • Sept. 12, 2025

Ozempic for cancer? Signs point to potential benefits of GLP-1s in oncology

Early academic research suggests various ways weight loss drugs could have an impact in cancer care.

By Michael Gibney • Sept. 12, 2025

LB Pharmaceuticals raises $285M in first major biotech IPO since February

LB Pharmaceuticals, which has a schizophrenia medicine headed for late-stage testing, broke one of the longest droughts for large IPOs in years.

By Gwendolyn Wu • Sept. 10, 2025

Kriya, Odyssey secure ‘megarounds’; Amgen boosts R&D leadership

Kriya’s $320 million raise ranks as one of the year’s largest private funding rounds. Elsewhere, a Genentech veteran joined Amgen and Merck and Daiichi touted results for a new kind of antibody-drug conjugate.

By Ben Fidler • Sept. 10, 2025

Novo Nordisk to lay off 9,000 workers in major restructuring

The drugmaker’s new CEO said the moves will help the company be more agile as it deals with competition in the obesity market and a declining stock price. 

By Kristin Jensen • Sept. 10, 2025

Lilly to give biotech startups access to AI tools

Insitro, Firefly Bio and Superluminal Medicines are among the first participants in Lilly’s “TuneLabs” platform, which the pharma says can help young drugmakers while training its own models.

By Gwendolyn Wu • Sept. 9, 2025

A new class of sleep drugs draws Wall Street’s attention

Clinical trial data presented this weekend show drugs from Takeda, Alkermes and Eisai significantly helped people with narcolepsy, heralding a new era of sleep medicine.

By Jacob Bell • Sept. 8, 2025

A UK biotech takes aim at Parkinson’s, ALS by drugging mitochondria

The venture arms of Merck KGaA and Novartis are among the investors involved in raising $67 million for NRG Therapeutics, which aims to bring its first medicine into clinical testing next year.

By Gwendolyn Wu • Sept. 8, 2025

Driving precision oncology development: Integrated biomarker testing solutions that deliver impact

Driving precision oncology with integrated biomarker testing that delivers results.

Sept. 8, 2025

FDA to publish CRLs in real time; PEPFAR to distribute Gilead’s Yeztugo

The FDA also unveiled a batch of 89 previously unpublished complete response letters, including rejection notices to Capricor and Replimune.

By BioPharma Dive staff • Sept. 5, 2025