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In patients stricken with ulcerative colitis for less than five years, AMT-101 was nearly three times more effective in inducing clinical remission than the placebo after eight weeks.
Findings from a study support the claim that the risk of developing a serious issue, such as respiratory or cardiac issues, is much more probable in the first 30 days following infection from COVID-19.
Eisai and Biogen’s BLA for lecanemab for Alzheimer’s disease received FDA Priority Review with a target action date of January 6, 2023, while Roche’s lymphoma drug scored the same designation.
CureVac has filed a lawsuit against BioNTech and two of its subsidiaries for allegedly infringing on its intellectual property rights over mRNA technology used in the COVID-19 vaccine.
The Phase II study, conducted in the Netherlands, evaluated the single-dose ANEB-001 in treating healthy participants affected by THC. Anebulo plans to file an IND with the FDA by the end of 2022.
As the calendar pages continue to turn, the FDA has a slew of novel drugs awaiting approval, several of which are likely to become game-changers for patients and key assets for companies.
The FDA lifted the clinical hold on Dyne Therapeutics’ clinical study of DYNE-251 in Duchenne muscular dystrophy (DMD) patients amenable to skipping exon 51. A Phase I/II trial is expected by mid-year.
Even though the COVID-19 pandemic appears to be under control, it’s clear that it’s not over, with the rise of more subvariants. Read on for more details.
Many healthcare, pharmaceutical and biotech companies continue to place their bets on China, bringing fresh rounds of investments to and forging new partnerships with local firms.
Following the Supreme Court’s decision to overturn Roe v. Wade, abortion rights activists are calling for the FDA to consider making abortion medication Mifeprex an over-the-counter option for patients.
The transaction, expected to close in the third quarter of this year, includes TeneoTwo’s proposed drug for relapsed and refractory B-cell non-Hodgkin lymphoma TNB-486.
Seagen announced positive data from its Phase II trial in colorectal cancer, and the FDA provided positive feedback supporting a Phase IIIb trial for ANeuroTech’s MDD drug.
