US FDA | HealthCare Middle East & Africa Magazine

FDA removes most doses of Ozempic from drug shortage list after Novo Nordisk resolves supply issues

21 March 202322 March 2023

USA — Novo Nordisk’s Ozempic, a treatment for type 2 diabetes and off-label for weight loss, is no longer on the FDA’s drug shortage list after months of limited supply.…

FDA advisory panel supports full approval of Pfizer’s COVID therapy

17 March 202317 March 2023

USA —Advisers to the U.S. Food and Drug Administration gave strong support for full approval of Pfizer’s oral antiviral COVID-19 treatment, Paxlovid, for adults at high risk of severe disease…

Pfizer’s Zavzpret nasal spray granted FDA approval for migraine treatment

14 March 202314 March 2023

USA — The U.S. Food and Drug Administration (FDA) has approved Pfizer’s Zavzpret (zavegepant) for the acute treatment of migraine in adult patients with or without aura. As the first…

Glenmark, Cediprof ink distribution pact for prescription drugs in the US

9 March 20239 March 2023

INDIA – Glenmark Pharmaceuticals and Cediprof, Inc. have entered into an exclusive supply and distribution agreement for the latter’s prescription drugs in the United States. Glenmark’s current portfolio consists of…

Revolutionary concussion detection blood test from Abbott receives FDA approval

9 March 202310 March 2023

USA— Abbott has received clearance from the U.S. Food and Drug Administration (FDA) for the first commercially available laboratory test for traumatic brain injury (TBI), which will be widely accessible…

Sun Pharma’s acquisition of Concert fuels hopes of deuruxolitinib push to FDA Drug Review

7 March 20238 March 2023

INDIA – Sun Pharma has wrapped up the acquisition of Concert Pharmaceuticals Inc. (Concert) with the desire to accelerate the market entry of deuruxolitinib, a potential best-in-class treatment for alopecia…

FDA encourages adoption of continuous manufacturing to build a resilient pharma sector

6 March 20237 March 2023

USA — The FDA has issued final guidance on the use of continuous manufacturing in drug production, aimed at easing the industry’s transition to these advanced processes. The guidelines cover…

FDA advisory panel to assess broader application of Merck-AstraZeneca cancer medication

5 March 20236 March 2023

USA —Merck & Co Inc and AstraZeneca have announced that an independent committee of advisers to the U.S. Food and Drug Administration (FDA) will evaluate their application for the expanded…

FDA approves once-weekly hemophilia drug from Sobi and Sanofi

24 February 202324 February 2023

USA — The U.S. Food and Drug Administration (FDA) has granted approval for a new hemophilia treatment co-developed by Sanofi and Sobi that has the potential to offer greater convenience…

U.S. and EU regulators to expedite reviews of Pfizer’s RSV vaccine

22 February 202322 February 2023

USA — Pfizer has announced that regulatory authorities in the US and Europe have accepted marketing applications for its RSVpreF vaccine candidate for respiratory syncytial virus (RSV), with decisions expected…