Category: Regulations

October 25, 2023

The US Food and Drug Administration (FDA) has granted clearance for Endogena Therapeutics’ investigational new drug application to treat geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD). The FDA clearance will enable Endogena to progress with the […]

October 19, 2023

A Senate committee finally held a hearing Wednesday on President Joe Biden’s pick to lead the National Institutes of Health. But the panel’s chair, Sen. Bernie Sanders (I-Vt.), was focused on drug prices — an issue over which the NIH […]

October 18, 2023

Typically, an FDA rejection is the end of the regulatory road for an experimental drug. With Tuesday’s approval of Xphozah, Ardelyx is the rare company to overcome such a hurdle, some two years after it received a complete response letter […]

October 17, 2023

The U.S. Food and Drug Administration approved Velsipity (etrasimod) for adults with moderately to severely active ulcerative colitis (UC). The approval was based on results from the ELEVATE UC phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12) […]

October 13, 2023

In clinical trials, Velsipity helped 27% of patients taking it go into remission at 12 weeks and 32% at 52 weeks, significantly higher than the 7% of patients who received placebos at both time points. The pill also showed a […]

October 12, 2023

Care Access had disagreed with Pfizer and Valneva’s decision to remove more than 3,000 participants from the study over alleged violations of Good Clinical Practice, an international ethical and scientific standard clinical researchers must follow during trials. But the setback […]

October 11, 2023

The U.S. Food and Drug Administration is warning consumers about risks of using compounded versions of the drug ketamine, often taken for psychiatric disorders. Compounded products are not evaluated by the FDA for safety and effectiveness. They’re also not regulated […]

October 11, 2023

The regulator said it is currently seeking nominations of individuals with “technical and scientific expertise from diverse disciplines and backgrounds” who can advise it on the benefits, risks, and clinical outcomes associated with the use of digital health technologies (DHTs). […]

October 9, 2023

Onpattro (patisiran) has been approved in the US since 2018 as a treatment for polyneuropathy caused by ATTR, but Alnylam was hoping to expand its use to include patients with the disease who are experiencing cardiac complications of the disease. […]

October 6, 2023

The negative panel vote is a setback in Amgen’s efforts to cement Lumakras’ U.S. approval, but doesn’t appear likely to result in the drug’s withdrawal from market. Many of the advisers, in explaining their “no” votes, indicated they were ruling […]

October 3, 2023

Federal regulators are cautioning doctors not to give probiotics to preterm infants. An infant given probiotics at an undisclosed hospital has died, U.S. Food and Drug Administration officials said in a recent warning letter. Preterm infants given probiotics are at […]

October 2, 2023

It is common knowledge that messenger RNA (mRNA) advances saved lives and limited the extent of the COVID-19 pandemic. Far less recognized, even in the science and technology community, is the decade-long nurture and support governmental organizations provided the mRNA […]

October 2, 2023

The complete response letter (CRL) from the US regulator did not mention any concerns about the clinical data package, safety or label for lebrikizumab, raising the hope that any delay will not be too long – assuming the issues at […]

September 29, 2023

Faced with growing reports of inaccurate clinical lab tests, the U.S. Food and Drug Administration on Friday announced that it will for the first time regulate these vital diagnostic tools. Many Americans might have assumed that the FDA already had […]

September 27, 2023

Ozempic, a type 2 diabetes drug that has increasingly been used to help with weight loss, will now be labeled as having the potential to block intestines. The U.S. Food and Drug Administration recently made the label update for the […]

September 26, 2023

On Sept. 21, 2023, FDA released a new guidance on how the agency plans to utilize alternative tools to remotely evaluate drug manufacturing facilities identified in a marketing application. The application may be a new drug application, an abbreviated new […]

September 18, 2023

On Sept. 15, 2023, FDA announced the publication of a draft guidance to assist sponsors of biosimilars and interchangeable biosimilars develop draft labeling. The labeling recommendations are only for prescribing information, “except for certain recommendations in section V, FDA-Approved Patient […]

September 15, 2023

The US is currently experiencing a shortage of 15 cancer drugs as a result of manufacturing and supply chain issues. Three of these drugs – cisplatin, carboplatin and methotrexate – have been staples of cancer treatment for decades, but their […]

September 13, 2023

Advisers to the Food and Drug Administration on Wednesday endorsed Alnylam Pharmaceuticals’ drug Onpattro for a rare heart condition, despite questions from agency scientists over the degree of benefit offered by the RNA-based therapy. The advisory committee’s 9-3 vote sets […]

September 8, 2023

Lotronex (alosetron hydrochloride) and approved generics are FDA approved for the treatment of irritable bowel syndrome in women whose predominant bowel symptom is diarrhea. Although safety risks for Lotronex (alosetron hydrochloride) and approved generics still exist, FDA has determined the […]