US FDA | HealthCare Middle East & Africa Magazine

Dr. Reddy’s blockbuster drug Difluprednate Ophthalmic Emulsion enters the U.S. market

31 January 20231 February 2023

INDIA – Dr. Reddy’s Laboratories has secured the U.S. Food and Drug Administration (USFDA) approval for its eye drops for post-surgery care, Difluprednate Ophthalmic Emulsion 0.05%. Following the regulatory approval,…

FDA approves Merck’s Keytruda as adjuvant cancer treatment regardless of tumor’s PD-L1 expression levels

30 January 202330 January 2023

USA — The U.S. Food and Drug Administration (FDA) has cleared Merck & Co.’s immunotherapy Keytruda to treat early cases of lung cancer despite mixed results in the main study…

FDA revokes authorization for AstraZeneca’s Covid antibody drug Evusheld citing ineffectiveness

29 January 202330 January 2023

USA — Evusheld, a preventative monoclonal antibody treatment for COVID-19, has lost its emergency use authorization in the United States because it is unlikely to be effective against the coronavirus…

FDA approves Eli Lilly’s drug for advanced mantle cell lymphoma, to retail at US$21,000 per month

29 January 202330 January 2023

USA — The US Food and Drug Administration (FDA) has approved Eli Lilly and Co.’s drug (pirtobrutinib) for the treatment of a rare form of blood cancer. The indication aims…

U.S., Switzerland sign pharmaceutical good manufacturing practices agreement

26 January 202326 January 2023

USA — The U.S. FDA has signed an agreement with Switzerland that will allow each country to rely on the “other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities, avoiding…

Sun Pharma unveils its novel injection for neonatal seizures in the US

25 January 202325 January 2023

INDIA – Sun Pharma has launched its phenobarbital sodium injection for the treatment of neonatal seizures, SEZABY, in the United States (US). The Mumbai-based multinational pharmaceutical company has expanded its…

FDA details approach for finding optimal dosages for new cancer drugs

18 January 202319 January 2023

USA — The US Food and Drug Administration (FDA) has issued a draft guidance to help sponsors identify the optimal dosage for cancer drugs in clinical development and in it,…

Sun Pharma introduces novel anti-cancer drug, FDA issues warning letter to its Halol plant

16 January 202316 January 2023

INDIA – Sun Pharmaceutical Industries Limited (Sun Pharma) has expanded its product portfolio with the launch of its novel anti-cancer drug Palbociclib under brand name ” PALENOTM ” in India.…

FDA approves Novo Nordisk’s diabetes pill as first-line therapy

16 January 202316 January 2023

USA — The US Food and Drug Administration (FDA) has approved a label update for Novo Nordisk’s oral semaglutide (Rybelsus) allowing the agent to be used as an initial treatment…

Dr. Reddy’s nabs trademark rights of high-quality breast cancer drug from Pfizer

16 January 202319 January 2023

INDIA – Dr. Reddy’s Laboratories Ltd. has acquired the domestic sale rights for breast cancer drug PRIMCYV® from Pfizer Products India Pvt Ltd. The trademark rights acquisition will build on…