The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) over Acadia Pharmaceuticals’ supplemental New Drug Application (sNDA) for Nuplazid for hallucinations and delusions associated with dementia-related psychosis.

The U.S. Food and Drug Administration accepted AbbVie’s New Drug Application for atogepant, an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist for the preventive treatment of migraine in adults who meet criteria for episodic migraine.

Copenhagen, Denmark-based Orphazyme announced the company’s Phase II/III clinical trial of arimoclomal for inclusion body myositis (IBM) failed to hit primary and secondary endpoints.

Oyster Point’s New Drug Application (NDA) for the dry eye disease therapy OC-01 was accepted for FDA regulatory review on the back of positive Phase III data.

Bristol Myers Squibb announced positive data from POETYK PSO-2, the second Phase III trial of deucravacitinib for moderate to severe plaque psoriasis, evaluated against placebo and Amgen’s Otezla (apremilast).

Positive high-level results from the ELEVATE-RR Phase III trial showed AstraZeneca’s Calquence (acalabrutinib) met the primary endpoint demonstrating non-inferior progression-free survival for adults with previously treated, high-risk chronic lymphocytic leukemia (CLL) compared to ibrutinib.

An investigational oral MK2 inhibitor from clinical-stage biopharmaceutical company Aclaris Therapeutics was safe and associated with promising reductions in inflammatory markers in a 12-week, Phase II study of patients with moderate to severe rheumatoid arthritis (RA).

A small trial of Eli Lilly’s donanemab showed the experimental Alzheimer’s drug slowed by about a third the rate of decline in a combined measure of cognition and function in patients at an early stage of the mind-wasting disease.

AbbVie’s Phase III induction study, U-ACHIEVE, of Rinvoq (upadacitinib) in moderate to severe ulcerative colitis hit the primary endpoint of clinical remission at week 8 and also met all ranked secondary endpoints.

Moderna announced plans to submit the company’s request to the U.S. Food and Drug Administration for an Emergency Use Authorization (EUA) for the Covid-19 vaccine mRNA-1273 on Nov. 30.