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Jefferies analysts said the approval was largely expected and an “incremental positive” for Moderna amid questions about the FDA’s attitude toward mRNA and COVID-19 vaccines that have investors worried.
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While the last decade has brought considerable progress for patients with DMD, substantial unmet need remains. Several companies including Wave, Dyne and Avidity are looking to answer the call with investigational therapies targeting greater efficacy and broader reach.
Less than a day into his second term, President Donald Trump ordered a freeze on communications at major public health agencies, among other moves that have sent waves through the biopharma industry.
At J.P. Morgan, most biopharma executives expressed a neutral stance on the incoming administration, but just days later, President Trump issued multiple executive orders that concern the industry.
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Poseida Therapeutics, Inc., a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, announced that the Compensation Committee of its Board of Directors granted an inducement award to an employee.
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Read our takes on the biggest stories happening in the industry.
The HHS secretary recently canceled $500 million worth of BARDA contracts around mRNA vaccine research. But the U.S. government has already spent billions on this work, which has saved millions of lives.
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As Marty Makary nears the end of his first month on the job, the FDA Commissioner sat down for two interviews, offering statements that alternatively contradict and jibe with reported events.
While AbbVie handily beat expectations this quarter, the company faces declining Humira sales and a challenged aesthetics business, plus the same macro headwinds blowing against the entire industry.
The hold, placed by the FDA on an early-stage clinical trial of an experimental BET inhibitor, stems from a recent observation of testicular toxicity in canines given the treatment.
Big compounders will have until May 22 to stop producing and dispensing compounded semaglutide, while smaller, state-run pharmacies must immediately stop making copies of the blockbuster drug.
Despite steep budget and staffing cuts at the FDA in recent weeks and other headwinds, Gilead CEO Daniel O’Day assured investors that the pharma’s plans and preparations for lenacapavir’s launch remain on track.
Presentations at this year’s American Association for Cancer Research meeting could have a broad impact on the treatment landscape for head and neck and lung cancer, and implications for specific drug modalities like TIGIT and VEGF.
Despite a dip in sales and a recent schizophrenia stumble, the company drew an optimistic outlook for sales for the rest of the year, even as the specter of pharmaceutical tariffs looms.
Merck, Bristol Myers Squibb, Sanofi and Roche had little clarity on the potential impact of President Donald Trump’s pharmaceutical tariffs but many companies are already preparing for what’s to come.
Granite will focus on two antibody therapies, both targeting crucial players in the inflammatory cascade to address autoimmune diseases.
In this episode presented by DIA, BioSpace’s head of insights Lori Ellis discusses how collaboration and investment shape the the future of women’s health with Martin Hodosi, partner at Kearney and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine.