The U.S. Food and Drug Administration approved Vyvgart (efgartigimod alfa-fcab) for the treatment of generalized myasthenia gravis (gMG) in adult patients positive for anti-acetylcholine receptor (AChR) antibody.

The U.S. Food and Drug Administration approved Intra-Cellular Therapies Inc.’s Caplyta for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate.

AstraZeneca

The U.S. Food and Drug Administration approved AstraZeneca and Amgen’s drug Tezspire to treat severe asthma for those aged 12 years and older, the companies said on December 17.

Shares of Global Blood Therapeutics were up more than 10 percent in trading on December 17 following regulatory approval of a supplemental New Drug Application for oral Oxbryta (voxelotor) tablets for the treatment of pediatric sickle cell disease (SCD).

AbbVie’s Rinvoq won approval from the U.S. Food and Drug Administration for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or demonstrated an intolerance to one or more tumor necrosis factor (TNF) blockers.

The U.S. Food and Drug Administration approved Merck’s blockbuster checkpoint inhibitor Keytruda (pembrolizumab) for adjuvant treatment of renal cell carcinoma (RCC) patients at intermediate-high or high risk of recurrence after nephrectomy or following nephrectomy and resection of metastatic lesions.

The U.S. Food and Drug Administration approved Seqirus’ Flucelvax Quadrivalent (Influenza Vaccine), the company’s cell-based quadrivalent influenza vaccine, for an expanded age indication for children as young as 6 months old.

Eisai

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.

Two weeks after winning U.S. approval as a treatment for adults with Waldenstrom’s macroglobulinemia, BeiGene’s Brukinsa scored again as a treatment for adult patients with relapsed or refractory marginal zone lymphoma (MZL).

A study published in the BMJ suggests that about one-third of cancer indications receiving approval under an Accelerated Approval pathway are still on product labels even after follow-up studies did not confirm their benefits.