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While Daiichi Sankyo brought in $13.4 billion in 2025, setbacks forced the company to update its antibody-drug conjugate forecast, pushing demand below the minimum supply agreed upon with CMOs and prompting the cancellation of an in-house investment.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.
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The precision neuroscience startup has notched $109 million in seed, Series A and B financing as it looks to further develop a Phase I candidate to treat a rare X-linked neuromuscular disorder.
The company’s second antibody-drug conjugate deal of 2023, with Shanghai-based LaNova Medicines, adds a potential first-in-class GPRC5D-directed ADC for multiple myeloma.
Veozah, an oral once-daily medication, is the first FDA-approved NK3 receptor antagonist for hot flashes, a common symptom of menopause that can affect health and quality of life.
Preliminary trial results show the GSK five-in-one meningitis vaccine is immunologically effective against the most common strains, as the FDA decision date for Pfizer’s candidate looms.
Nirsevimab lowered hospitalizations due to RSV-related lower respiratory tract disease by 83.21%. Friday’s data drop comes ahead of next week’s advisory committee meeting for Pfizer’s RSV hopeful.
Despite concerns regarding neffy’s lack of clinical evidence, the panel of experts voted in favor of the nasal spray’s approval for the emergency treatment of type 1 allergic reactions.
Lawmakers on Thursday voted 18–3 to increase oversight of pharmacy benefit managers and limit their practice of spread pricing, when PBMs charge payers for drugs more than they pay pharmacies.
The FDA has four events lined up this week, including a target action date for Krystal Biotech’s gene therapy for a rare skin disease and an adcomm meeting for Pfizer’s RSV vaccine candidate.
The regulator in a Complete Response Letter rejected ImmunityBio’s bladder cancer hopeful due to deficiencies with the company’s third-party contract manufacturer.
The Chapter 11 bankruptcy was driven by increasing generic competition, declining profits and the unrelenting legal woes of its head Martin Shkreli, dubbed “Pharma Bro” in the media.