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With Siran Biotechnology under its fold, GSK will have access to a long-acting siRNA therapy that could induce weight loss while preserving lean mass, in addition to addressing other weight-related comorbidities.
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Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.
Biogen’s Qalsody won FDA approval in 2023 to treat a rare, genetic form of amyotrophic lateral sclerosis. On Tuesday, QurAlis presented interim Phase 2 data showing the potential of a similar drug to more broadly treat the neurodegenerative disease.
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The FDA in a complete response letter to Replimune maintained its original objection to the single-arm trial the biotech used to support the application for RP1.
Novo Nordisk’s oral Wegovy has a few months’ head start on Eli Lilly’s newly approved pill. While the Indianapolis pharma has come from behind the Danish rival in the weight loss space before, last time it clearly had the better drug.
In the future of AI-driven biopharma, reusable data is the most undervalued asset.
GSK discontinued Wellcovorin in 1999, but the FDA in September last year asked the pharma to refile an application, pointing to its potential to treat cerebral folate deficiency with “autistic features.”
A Louisiana court on April 7 asked the FDA to complete its internal review of mifepristone’s safety and gave the agency six months to provide the court with an update on the investigation.
The license, which Innovent’s Altruist business said is the first of its kind, positions the CDMO to support commercial clients as it works to expand the plant’s capacity to 172,000 liters.
Roche is jumping into degrader-antibody conjugates, a modality that in recent years has attracted investments from Merck KGaA and Bristol Myers Squibb.
BioSpace’s Biopharma Job Market Report reveals early signs of recovery for 2026. A rise in job postings, a surge in contract roles and strong M&A and IPO activity point to future hiring growth and shifts in hiring strategy.
Sidewinder Therapeutics’ bispecific antibody-drug conjugates target pairs of receptors found on cancer cells, which the company claims improves their specificity and minimizes off-target effects.
Industry leader Steve Ubl has served as PhRMA’s CEO for more than a decade, the longest tenure of any head of the trade group.