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Viridian Therapeutics’ Lumvoa is the first FDA-approved treatment for thyroid eye disease that includes data for both active and chronic forms of the illness.
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When the variance can’t be modeled, even disciplined biotech investors stop deploying. Here’s the cheapest fix for biotech’s investability problem.
Dual and even triple or quadruple track processes have come roaring back in 2026 thanks to a glut of M&A that has refilled investors’ wallets. Big Pharma is being put on notice that time is critical if they want to acquire.
Policymaking at FDA has been anything but business as usual under the Trump administration, but former regulators cite the agency’s new investigational new drug pilot program as a sign of normalcy.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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Bristol Myers Squibb and Johnson & Johnson will continue to test the asset in stroke and atrial fibrillation.
Bayer has let go of about 13,500 employees, including around 5,000 managers, since implementing a new operating model in early 2024. CEO Bill Anderson said in a recent earnings call that he expects a slower rate of headcount reduction moving forward.
“As the future chair I will attend to the interests of not only the Novo Nordisk Foundation but all shareholders of the company,” incoming chair and former Novo Nordisk CEO Lars Rebien Sørensen said at the meeting held Friday.
A day after Pfizer closed its hotly contested Metsera deal, Lundbeck has made an unsolicited offer to steal Avadel Pharmaceuticals away from Alkermes.
At $9.2 billion, the Cidara acquisition lands among the top 5 largest deals of the year.
Gilead’s investigational drug combo bic/len could help lower the pill burden in patients with virologically suppressed HIV who are on complex treatment regimens, according to BMO Capital Markets.
A BioNTech spokesperson downplayed the news, insisting that the two companies remain “close” and have a “strong collaboration.”
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Speaking at a conference this morning, Pfizer CEO Albert Bourla suggested that Metsera’s therapies could begin hitting the market in 2028.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.