Canada has approved Amylyx Pharmaceuticals’ treatment for amyotrophic lateral sclerosis (ALS), a neurodegenerative disease, the first such approval for the oral drug. The decision came with certain conditions, including the release of data from its global late-stage study of about 600 patients, which is expected in 2024, as well as additional studies.
Moderna announced that the company’s Omicron-containing COVID-19 booster candidate, mRNA-1273.214, demonstrated superior antibody response against Omicron in its Phase II/III study. The booster contains the original COVID-19 vaccine, Spikevax, as well as a vaccine targeting the Omicron variant.
The U.S. Food and Drug Administration (FDA) approved Dupixent (dupilumab) for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Leaderboard Branding, a Fingerpaint company – the fast-growing global naming and branding firm that delivers strategic insights and world-class creativity to biopharma and healthcare companies as early as clinical phase 1 – announced the hiring of Max Straka, PharmD, FISMP, a former FDA Division of Medication Error Prevention and Analysis (DMEPA) safety evaluator. As a Director of Leaderboard Branding’s Drug Safety Division, Dr. Straka adds to the broad experience of global leaders and innovators in this important area of drug development.
GSK said on Monday the British drugmaker’s vaccine Priorix was approved by the U.S. Food and Drug Administration for the prevention of measles, mumps and rubella (MMR) in those aged 1 year and above.
A federal agency will start a review if the U.S. Food and Drug Administration properly conducted the health regulator’s inspection of Abbott’s Michigan plant and oversaw baby formula recalls that led to severe shortages in the United States.
The U.S. Food and Drug Administration (FDA) is on a mission to recover from the review lag seen through the early years of COVID-19 and has issued special designations for two treatments that could improve the lives of millions diagnosed with recurrent glioblastoma or hemophilia.
New York-based Axsome Therapeutics published results from the pivotal Phase III Gemini trial of AXS-05 (dextromethorphan-bupropion) in major depressive disorder (MDD).
The U.S. Food and Drug Administration said on Wednesday it has withdrawn the health regulator’s approval for TG Therapeutics Inc.’s lymphatic cancer treatment Ukoniq over concerns of higher risk of death in patients receiving the drug.
U.S. President Joe Biden will meet with major infant formula manufacturers on Wednesday as his administration presses ahead with efforts to boost imported supplies to help ease a nationwide shortage.