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After the FDA’s decision to reject a review of Moderna’s mRNA-1010 flu shot, executives explain what Americans will miss out on as other nations embrace the technology.
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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.
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.
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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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Despite their initial kicking and screaming, drugmakers seem confident the Inflation Reduction Act’s Medicare Drug Price Negotiation Program will not greatly impact their bottom lines.
Bristol Myers Squibb on Friday reported strong second-quarter results, led by the blood thinner Eliquis and cancer therapy Opdivo, as it looks to cut $1.5 billion in costs by 2025.
Encouraged by the potential of the weight-loss candidates acquired from Carmot Therapeutics, Roche will speed up the development of its obesity programs, seeking to differentiate itself in the market.
The FDA’s Oncologic Drugs Advisory Committee on Thursday strongly supported changing clinical trials for non-small cell lung cancer drugs given in the perioperative setting, pointing out the need for a more nuanced approached to treatments before and after surgery.
The company’s FcRn inhibitor Vyvgart grew 17% quarter-over-quarter, reigniting confidence it will hit its ambitious goals despite a string of clinical setbacks in recent months.
While Humira sales were impacted by cheaper biosimilars, AbbVie reported in its second-quarter earnings results Thursday that revenues jumped nearly 45% for Skyrizi and almost 56% for Rinvoq year over year, respectively.
The three companies raised their respective full-year earnings forecasts on Thursday, buoyed by robust sales in the second quarter and their continued dominant market positions.
With promising Phase II data in hand, Viking Therapeutics is pushing its subcutaneous GLP-1/GIP receptor dual agonist into late-stage development, the company announced on Wednesday.
Novartis continues its dealmaking spree with a bet on Dren Bio’s Targeted Myeloid Engager and Phagocytosis platform to develop bispecific antibodies in oncology.
The regulator on Wednesday provided recommendations to drugmakers for assessing the use of electronic health records and medical claims data to support their applications.