FDA steps up enforcement of import rules because of Salmonella, pesticides and more

FDA plans unusual warning on COVID vaccines

The US Food and Drug Administration is planning an unusual and controversial step: adding a black box warning to COVID vaccines, the most severe regulatory warning in the FDA’s arsenal, according to a report Friday by CNN. The plan, which could be unveiled …

The FDA Rarely Forces Manufacturers to Recall Dangerous Medical Devices, Watchdog Report Finds

The Food and Drug Administration rarely uses its authority to pull dangerous medical devices off the market and is so poorly staffed that it’s sometimes unable to make sure companies are taking critical steps to protect patients during health emergencies, …

FDA moves to update sunscreen standards with the addition of bemotrizinol

Amid push to modernize OTC standards in the U.S., the FDA has proposed on Thursday, December 11, to add bemotrizinol [1] as a permitted active ingredient for use in sunscreen products. This broad-spectrum UV filter is widely used worldwide to protect …

FDA Considers Black Box Warning for COVID-19 Vaccines Amid Safety Debates

The U.S. Food and Drug Administration (FDA) plans to require a ‘black box’ warning for Covid-19 vaccines, according to two sources familiar with the agency’s plans. Such a warning is the highest level of precaution that appears at the top of information …

<![CDATA[FDA Clears Pivotal Phase 3 PREVAiLS Study of Pridopidine in Early, Rapidly Progressive ALS]]>

According to a new announcement, the FDA has cleared the iniatation of a pivotal, 500-patient, randomized, placebo-controlled phase 3 trial dubbed PREVAiLS, which will assess the efficacy and safety of pridopidine (Prilenia Therapeutics/Ferrer) in …

Aurobindo Pharma’s subsidiary receives US FDA Form 483 with three procedural observations after Telangana facility ...

Aurobindo Pharma has recently informed exchanges that the United States Food and Drug Administration (US FDA) completed an inspection of Unit-V, the API manufacturing facility of Apitoria Pharma Private Limited, its wholly owned subsidiary located in the …

FDA Grants Orphan Drug Status to Ajax’s AJ1-11095 for Myelofibrosis

Ajax Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to AJ1-11095, the company’s next-generation JAK inhibitor being developed for patients with myelofibrosis. The rare, debilitating blood cancer …

FDA Approves First New Oral Antibiotic Class for Gonorrhea in 30+ Years

The FDA has approved GSK's gepotidacin (Blujepa), the first new antibiotic class for gonorrhea in over three decades, offering a crucial option amid rising drug resistance. Phase 3 EAGLE-1 trial results showed a 92.6% success rate, comparable to …

Florida and Texas sue FDA over abortion drugs, claim decisions violate state laws

TALLAHASSEE, Fla. (CBS12) — A lawsuit filed by Florida and Texas is challenging more than two decades of federal government decisions that have cleared the way for the use of abortion drugs, CBS12's News partners the South Florida Sun Sentinel states. …