The U.S. Food and Drug Administration approved Aduhelm for the treatment of Alzheimers, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.

Takeda Pharmaceutical Company Limited announced that the U.S. Food & Drug Administration (FDA) has accepted a New Drug Application (NDA) for maribavir for the treatment of CMV infection in those that are refractory with or without resistance (R/R), in solid organ transplant (SOT) or hematopoietic cell transplant (HCT) recipients.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration has granted the accelerated approval of RYBREVANTTM (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

The U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression. 

Zydus Cadila has received final approval from the USFDA to market Propafenone Hydrochloride Extended- Release Capsules USP, 225 mg, 325 mg, and 425 mg (US RLD: Rythmol Capsules). Propafenone is known as an anti-arrhythmic drug. It works by blocking the activity of certain electrical signals in the heart that can cause an irregular heartbeat.

The U.S. Food and Drug Administration has authorized marketing of the Hominis Surgical System, a new robotically-assisted surgical device (RASD) that can help facilitate transvaginal hysterectomy in certain patients. The Hominis Surgical System is intended for benign hysterectomy (removal of the uterus for non-cancerous conditions) with salpingo-oophorectomy (removal of one or both fallopian tubes and ovaries).

Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.