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The FDA placed a clinical hold on the program due to a determination that there is insufficient information to support dose escalation with the product.
Orphalan announced the FDA has granted full approval to Cuvrior (trientine tetrahydrochloride) for the treatment of Wilson’s Disease, a rare genetic disorder.
Hutchmed failed to secure FDA approval for its proposed drug for pancreatic cancer. The company will have to go through another trial if they want U.S. approval.
Arguments regarding the Purdue Pharma opioid settlement continue to be heard in court, Natera battles a class-action lawsuit, Walgreens is involved in a public nuisance suit and more.
Speculations that Biogen might appeal the decision after reports of the company hiring several lobbyists, including Clyburn Consulting and Federal Street Strategies.
Emergent BioSolutions Founder and former chief executive officer Fuad El-Hibri has died, the company reported.
Enavate Sciences launched with an initial capital investment of $300 million from health care investment firm Patient Square Capital. Enavate is a new biotech investment firm.
Gilead and Dragonfly announced their collaboration today, with an end goal of bringing the DF7001 NK engager program designed for patients with cancer or inflammatory diseases.
Tarsus announced positive topline data from its Phase III clinical trial of TP-03 Demodex blepharitis, along with the commencement of an underwritten public offering of $50 million of shares of its common stock.
Public health officials are seeing a notable rise in cases and expressing concerns over more subvariants of the SARS-CoV-2 virus. For those stories and more, continue reading.
Pfizer vaccine head Kathrin Jansen is stepping down from the pharma giant after spearheading the development of the COVID-19 vaccine Comirnaty.
The FDA is quickly catching up after COVID-19 disrupted typical review timelines and planned inspections and Monday morning held bad news for Coherus, Junshi and Axsome.