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Moderna will not commit to previous 2028 breakeven guidance as the ripple effects of the FDA’s refusal-to-file decision spread through its pipeline.
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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.
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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.
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AstraZeneca last week set another ambitious goal, this time with plans to nearly double its total revenue by the end of the decade. However, it’s easier said than done, according to analysts.
The FDA currently does not recommend using changes in lean mass as an endpoint in clinical trials for weight loss drugs. Should it?
AstraZeneca targets $80 billion in revenue by 2030, layoffs at Bayer, BMS and Pfizer continue to generate attention across the biopharma industry, Takeda takes a deep dive into the molecular glue space and conference season is in full swing.
Johnson & Johnson’s deal for Numab Therapeutics’ bispecific antibody NM26, slated to enter Phase II studies, comes on the heels of J&J’s $850 million Proteologix bispecific antibody acquisition.
The potential purchase by the Japanese conglomerate could secure access to Calliditas’ IgA nephropathy therapy Tarpeyo, which won the FDA’s full approval in December 2023.
NS Pharma, a subsidiary of Nippon Shinyaku, announced Monday that its Duchenne muscular dystrophy candidate Viltepso failed a late-stage confirmatory trial, showing no significant motor function improvements over placebo.
Flagging a risk of hypoglycemia, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Friday did not recommend the approval of Novo Nordisk’s once-weekly insulin icodec for type 1 diabetes.
With back-to-back victories in IgA nephropathy and C3 glomerulopathy, Novartis on Saturday said it is planning to make regulatory submissions for the rare kidney diseases this year.
AstraZeneca and Daiichi Sankyo’s investigational antibody-drug conjugate Dato-DXd failed to significantly improve overall survival in non-small cell lung cancer patients versus docetaxel.
While NK cell therapies can potentially avoid the serious side effects sometimes seen with CAR T cell therapies, experts say durability may stall their path to the market.