Pfizer Inc. and BioNTech SE on Sept. 28 submitted initial trial data for their Covid-19 vaccine in 5-11 year olds and said they would make a formal request with U.S. regulators for emergency use in the coming weeks.
Eisai Co. on Sept. 27 began the application process for the Japanese drugmaker’s experimental drug lecanemab for early Alzheimer’s disease using an accelerated approval pathway, the same path that helped Eisai’s development partner Biogen Inc. win U.S. approval of its medication in June.
Booster shots to bolster immunity against the coronavirus would be free and accessible, U.S. President Joe Biden said on Friday, one day after federal health agencies backed a booster rollout.
Incyte announced Sept. 22 that the Food and Drug Administration approved the company’s Jakafi (ruxolitinib) to treat chronic graft-versus-host disease, one day after the U.S. regulator gave the green light to the cream Opzelura (ruxolinitib) for the short-term and non-continuous chronic treatment of mild-to-moderate atopic dermatitis.
The U.S. Food and Drug Administration on Sept. 21 approved Incyte Corp.’s cream Opzelura for treating the inflammatory skin condition atopic dermatitis, commonly called eczema, in adolescents and adults with boxed warnings.
Shares of Verrica Pharmaceuticals plunged after the company received a Complete Response Letter from the U.S. Food and Drug Administration for an experimental treatment for molluscum contagiosum (molluscum).
Positive final results from the Phase III COSMIC-311 trial for Cabometyx (cabozantinib) were reported by Exelixis for patients diagnosed with previously treated radioactive iodine-refractory differentiated thyroid cancer.
Genmab A/S and Seagen Inc. announced that the U.S. Food and Drug Administration granted accelerated approval to Tivdak (tisotumab vedotin-tftv), the first approved antibody-drug conjugate for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Initial results from a vaccine trial reported Sept. 20 showed that Pfizer and BioNTech’s Covid-19 vaccine might be safe for use in children under 12 years old.
The U.S. Food and Drug Administration on Sept. 20 approved South Korean drugmaker Samsung Bioepis Co. Ltd. and Biogen Inc.’s biosimilar rival to Roche Holding AG’s blockbuster eye medicine Lucentis.
