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The FDA has four big events in the coming two weeks, including an advisory panel meeting for an ultra-rare disease.
The European Medicines Agency’s Committee for Medicinal Products for Human Use found that Leqembi’s benefits do not outweigh the risks of severe side effects associated with the treatment.
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.
Employed and unemployed biotech and pharma professionals are thinking about job hunting in other fields amidst a challenging labor market.
When you don’t get the promotion you wanted, it’s important to assess your company and yourself so you can improve your odds in the future.
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The company’s candidate, giroctocogene fitelparvovec, met its primary and key secondary objectives of superiority compared to the standard treatment of regular Factor VIII infusions.
A longtime biopharma exec and Moderna shareholder argues in an anonymous email to the companies’ CFOs that they have a fiduciary responsibility to close the deal. Analysts say the proposal is interesting but “too simplistic.”
Biogen and Sage Therapeutics’ investigational neuroactive steroid did not significantly improve upper limb tremors in patients with essential tremor, the companies announced Wednesday.
AstraZeneca is proposing to use Imfinzi for resectable non-small cell lung cancer in the perioperative setting—both before and after surgical resection of the tumor. However, ahead of Thursday’s advisory committee meeting, FDA staffers have expressed concerns.