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FDA grants approval for Amylyx’s Relyvrio to treat ALS

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Amylyx Pharmaceuticals’ Relyvrio (sodium phenylbutyrate and taurursodiol) to treat adult patients with amyotrophic lateral sclerosis (ALS). The FDA approval is based on findings from the multicentre Phase II CENTAUR clinical trial that enrolled 137 ALS patients.

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FDA Authorizes Marketing of MISHA™ Knee System for People Suffering from Knee Osteoarthritis

Legacy MEDSearch

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. Chief, Hip and Knee Division of Sports Medicine Institute, Hospital for Special Surgery in New York. This system fills that void for both surgeons and patients.”

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Alzheimer’s disease not forgotten as FDA oversees record number of designations awarded

Pharmaceutical Technology

The FDA has seen a record surge in review designations being awarded over the last two years for Alzheimer’s indications, with 12 review designations being awarded to drugs between 2020 and 2022. The development of novel and effective drugs is of special importance. Note: drugs can be awarded multiple review designations. ©GlobalData.

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CDC and FDA Recommendations for SARS-CoV-2 Booster Shots

Pharmacy Times

Experts in the management of SARS-CoV-2 educate on CDC and FDA recommendations for approaching administration of booster vaccines, including those for special patient populations.

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A scientific approach to irrational consumer choices

World of DTC Marketing

GOOD MORNING: The FDA is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on measuring consumer perceptions of the information presented in ads. ” So, are we supposed to believe that better images in DTC ads lead to patients asking for an Rx? ” Uh…no.

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US FDA grants approval for Azurity’s Konvomep to treat gastric ulcer

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Azurity Pharmaceuticals’ Konvomep (omeprazole and sodium bicarbonate for oral suspension) to treat active benign gastric ulcer. Konvomep is also indicated for lowering the upper gastrointestinal bleeding risk in critically ill patients.

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alveoair® has received U.S. FDA clearance, marking a significant advancement in respiratory care

Legacy MEDSearch

FDA clearance for distribution in the United States. Specializing in digital therapeutics for respiratory care, the company is committed to delivering affordable and interoperable lung health solutions. FDA-cleared, portable digital spirometer, alveoair® is part of alveofit’s ecosystem. and emerging economies.

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