News
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
FEATURED STORIES
The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
A rapturous response to data published last year for Pelage’s hair loss candidate overwhelmed the biotech. Now, the company is ready to show the world the science behind the breakthrough.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
THE LATEST
The Swiss pharma has set up its challenge to AbbVie’s blockbuster immunosuppressive drug Humira with a label expansion for Cosentyx in hidradenitis suppurativa, a painful long-term skin condition.
Ahead of the Inflation Reduction Act’s drug price negotiations, the regulator has approved Amgen’s biosimilar challenge to Johnson & Johnson’s Stelara—with an interchangeable designation to boot.
The biotech venture capital firm, led by former Andreessen Horowitz senior partner Kouki Harasaki, emerged from stealth on Wednesday focused on investing in companies with first-in-class or best-in-class therapies.
The British biopharma and Arrowhead Pharmaceuticals have reached an agreement with J&J’s Janssen to transfer worldwide rights to develop and commercialize JNJ-3989 to GSK.
The biopharma industry is moving toward using AI to try to determine how well a given person would perform in a role, with applications that go beyond recruiting.
The investment in the French biotech is one of many the pharma giant has made this year to advance cell and gene therapy development. Cellectis shares skyrocketed over 180% in premarket trading Wednesday.
The British biopharma company reported 10% sales growth in the third quarter, driven mainly by robust sales of its respiratory syncytial virus shot Arexvy and shingles vaccine Shingrix.
The regulator has released Mersana Therapeutics’ antibody-drug conjugate XMT-2056 from its clinical hold, allowing the biotech to proceed with Phase I studies of the candidate with a lower starting dose.
The regulator’s advisory committee on Tuesday found Vertex Pharmaceuticals and CRISPR Therapeutics’ off-target analysis for its sickle cell disease candidate exa-cel to be sufficient.
Third-quarter revenues for antiviral treatment Paxlovid dropped 97% operationally compared with the prior-year period, while vaccine Comirnaty revenues declined 70% in the quarter.