FDA Issues EUA for Booster of Pfizer’s COVID-19 Vaccine

September 23rd 2021

People over the age 65 and those at high risk of severe COVID-19, including health care workers and those with occupational exposure, are eligible for the booster.

Par Launches Generic of Smoking Cessation Drug Chantix

September 22nd 2021

Dr. Reddy’s has also launched a generic of Librax. Recent generic approvals include clindamycin phosphate foam and sodium acetate.

FDA Approves Topical JAK inhibitor for Atopic Dermatitis

September 22nd 2021

Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States.

FDA Approves Tivdak for Advanced Cervical Cancer

September 22nd 2021

Tivdak is the first approved antibody-drug conjugate for the treatment of adult patients with recurrent or metastatic cervical cancer.

FDA has Accepted Application for Rare Epilepsy

September 21st 2021

The FDA assigned a PDUFA action date of March 20, 2022, for ganaxolone.