News
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
FEATURED STORIES
Dual and even triple or quadruple track processes have come roaring back in 2026 thanks to a glut of M&A that has refilled investors’ wallets. Big Pharma is being put on notice that time is critical if they want to acquire.
Policymaking at FDA has been anything but business as usual under the Trump administration, but former regulators cite the agency’s new investigational new drug pilot program as a sign of normalcy.
The FDA’s recently altered outlook on the evidence required for approval of rare disease drugs could have immediate benefits for companies including Skyhawk Therapeutics, Capricor Therapeutics and Biohaven.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
THE LATEST
The U.S. Equal Employment Opportunity Commission settled with Eli Lilly for $2.4 million after filing a suit in September over the company’s recruitment of younger workers.
Citing issues with a third-party contractor, the FDA rejected Regeneron’s regulatory application for a higher-dose regimen of Eylea, the company’s blockbuster eye injection treatment.
Despite a challenging economic climate and gloomy forecast, 2023 has still notched some mega-deals for biopharmas. BioSpace highlights the biggest deals in the industry this year.
The biopharma’s monoclonal antibody is the first to win approval for the two most common forms of generalized myasthenia gravis, a rare autoimmune and neuromuscular disorder.
Phase II results of MoonLake’s sonelokimab suggest superiority to the competition. Funds raised in the stock offering will support Phase III trials with an anticipated launch in 2027.
Though the topline data were sparse, Sanofi’s potentially first-in-class candidate amlitelimab improved Eczema Area and Severity Index scores in patients with moderate-to-severe atopic dermatitis.
An FDA advisory committee voted Wednesday that Ipsen’s fibrodysplasia ossificans progressive candidate palovarotene was effective and the benefits of the drug outweighed its risks.
Patients treated in a Phase II study with Lilly’s retatrutide saw up to 24% weight loss at 48 weeks, driven by a triagonist mode of action that can bind and activate the GLP-1, GIP and glucagon receptors.
Here are 10 career paths to consider that don’t include bench work, along with role descriptions and links to jobs available now on BioSpace’s job board.
Recent changes in the board of directors at Biogen has garnered attention due to potential conflicts of interest. Such conflicts vary widely, but one thing is clear: perception matters.