Takeda Pharmaceutical’s therapy for an allergic inflammation of the esophagus has received approval from the U.S. FDA, the Japanese drugmaker said on Monday, capping a years-long regulatory process.

The CEOs of Bristol Myers Squibb, Johnson & Johnson and Merck testified Thursday before the Senate health committee, defending the high U.S. prices that Americans pay for prescription drugs compared to other countries based on patient value and the need to fund innovation and R&D costs.  

FDA

The U.S. Food and Drug Administration has placed a clinical hold on Iovance Biotherapeutics’ lung cancer therapy trial after a patient death, the company said on Wednesday.

Apple on Tuesday appealed a decision to ban imports of its watches based on a complaint from medical monitoring technology company Masimo (MASI.O), after U.S. President Joe Biden’s administration declined to veto a government tribunal.

Zealand Pharma said on Saturday that the U.S. Food and Drug Administration (FDA) had declined to approve its drug for preventing and treating low blood sugar in children with a genetic disorder after finding deficiencies at a third-party manufacturing facility.

FDA

In a watershed U.S. regulatory milestone, the MAPS Public Benefit Corporation announced Tuesday that it has submitted a New Drug Application to the FDA for an investigational MDMA-assisted therapy for individuals with post-traumatic stress disorder.

Takeda

The FDA on Thursday approved Takeda’s recombinant ADAMTS13, now to be marketed as Adzynma, for the treatment of the rare blood disorder congenital thrombotic thrombocytopenic purpura—the biopharma company’s second approval in as many days.

Valneva

French drugmaker Valneva said on Friday the U.S. Food and Drug Administration (FDA) has approved its Chikungunya single-dose vaccine in individuals aged 18 and above.

The FDA on Wednesday approved Takeda’s fruquintinib for previously treated adults patients with metastatic colorectal cancer. The oral targeted therapy of the VEGF-1, -2 and -3 receptors will carry the brand name Fruzaqla.

In its second-quarter earnings report for fiscal year 2023, Eisai touted a sharp increase in the number of patients being treated with its Alzheimer’s disease therapy Leqembi (lecanemab).