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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.
Notably, Qelbree is the first novel FDA approval of a novel non-stimulant treatment for ADHD in adults in 20 years.
Since its $63 billion acquisition of Allergan in 2019, AbbVie has become one of the leading companies developing therapies for migraine.
Shares of Praxis Precision Medicines are falling after the company announced the FDA has placed a clinical hold on the company’s IND Application for its experimental epilepsy drug, Prax-222.
As May gets off to a slow start for the FDA calendar, a few companies have important target action dates.
A roundup of last week’s top clinical trial updates and news.
Several biopharma companies are closing out the month of April with expansions to facilities, including a $3 billion investment to develop next-generation life science ecosystems.
Gilead’s Veklury made massive profits, but as more vaccine boosters arrive and more people become immune to the virus, the future of the antiviral is in question.
AbbVie is off to a strong start for 2022 driven by success from Skyrizi and Rinvoq, as well as the company’s neuroscience platform. Abbvie also won FDA approval for a new indication for Rinvoq.