The Latest
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Zepbound, Mounjaro shortages are resolved, FDA confirms
The FDA’s decision will close a lucrative market opportunity for compounding pharmacies, although the agency will give a limited grace period before taking any enforcement actions.
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Merck’s RSV antibody could soon paddle into the rough waters of a crowded market
A new antibody from Merck would join a market teeming with new entries, but plenty of regulatory and financial uncertainty.
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Maternal mortality trends remain dire — and researchers face an uphill battle to solve them
Rising maternal mortality, particularly among vulnerable populations, stems in part from a lack of research in pregnant women.
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Big Pharma’s new DTC play: partnering with digital health providers
The pharma giant is looking for another edge in the competitive weight loss market through DTC expansion.
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A biotech’s race to tackle the most severe hepatitis
Bluejay Therapeutics is one of just a handful of companies developing treatments for hepatitis D.
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3 closely watched drugs that failed in the clinic
How recent setbacks and scattered successes could impact various sectors of the industry.
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Oncology, obesity and more: Where pharma R&D is headed in 2025
With a little more certainty coming to the market, the R&D environment in 2025 will be about pipeline prioritization and accelerating M&A.
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Will the ‘anti-woke’ movement derail DEI efforts in pharma?
Amid the DEI backlash in corporate America, pharma leaders are quietly adjusting tactics.
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Q&A
Regeneron’s R&D approach scores dual wins against Alexion’s Ultomiris and in lymphoma
At this year’s ASH conference, Regeneron posted results for treatments that could disrupt the standards of care in two blood-related diseases.
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GLP-1 compounding is still in limbo. Will the FDA leave it for the next administration?
The agency has yet to make a decision about keeping tirzepatide on or off of its shortage list — letting compound pharmacies continue their lucrative operations for now.
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Deep Dive
Endometriosis drug research, long underfunded, confronts familiar problems in women’s health
Despite the disease’s prevalence, endometriosis remains misunderstood, and research into drugs that might treat it draws scant funding — problems that have deep roots.
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What’s next for 23andMe?
Amid its plummeting stock value, layoffs and cuts to its drug R&D program, the battered company is carrying on.
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GSK’s multiple myeloma ADC Blenrep was pulled from the market. Now, it’s poised for a comeback.
GSK’s cancer drug failed a confirmatory trial two years after an accelerated approval, but impressive new survival data could change the tide.
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Psychedelics haven’t fulfilled clinical expectations, but new trial strategies could turn the tide
Leading companies in the psychedelics space have had trouble crossing the regulatory threshold. Here’s where they’re going wrong — and how to fix it.
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A drug for fewer than 1,000 patients? Awareness and diagnosis are key.
Zevra Therapeutics is building a commercial strategy for an ultra-small patient pool.
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Trump’s tariffs could put more pressure on the U.S. to produce generic drugs. Are we ready?
The push to bring generic drug production back home has failed to reach a critical mass.
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GSK taps a startup for shot at Alzheimer’s drug
The collaboration deal, which could be worth hundreds of millions of dollars, is a “pivotal moment” for Muna Therapeutics, a startup that launched less than four years ago.
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Q&A
How Astellas juggles the moving parts of cancer precision medicine development
While developing its first-in-class gastric cancer drug Vyloy, Astellas had to coordinate with another pharma giant to usher the precision med into the market.
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With Makary set to face FDA commissioner hearings, how deep do his industry ties run?
Dr. Marty Makary’s conflicts of interest could come into question before he is confirmed as the next FDA commissioner.
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The big rebrand: Why these 4 biopharmas changed their name this year
Four companies that refreshed their mission and public persona with a new look.
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Can the girl power of Arrivo’s depression drug help reverse its fortunes?
After failing a mid-stage trial, the biotech shifted course and is now targeting females with the goal of proving gender can play a role in depression outcomes.
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Note from the Editor-in-Chief
A change in ownership and what it means for our readers.
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How Alexion markets a rare disease drug by ‘starting with the end in mind’
The biopharma, now an arm of AstraZeneca, needs to build the plane while flying it to be first in rare diseases with no other option.
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Milk-based therapies could be coming. This biotech CEO is aiming to lead the way.
Intrinsic Medicine is entering phase 2 trials in Parkinson’s disease and IBS for its human milk oligosaccharide drug candidates next year.
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Specialized CROs aim to boost participation among women and other underrepresented groups
Lindus Health’s women-focused CRO is the latest in a handful of research efforts to target specialized — and underrepresented — populations.