Category: Regulations

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On Sept. 15, 2023, FDA announced the publication of a draft guidance to assist sponsors of biosimilars and interchangeable biosimilars develop draft labeling.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 […]

September 1, 2023

The Food and Drug Administration’s decision last month not to approve a new treatment for one of the most common forms of depression was, in part, due to safety concerns, according to newly released documents detailing the agency’s review process. […]

August 30, 2023

The Biden administration has picked the first 10 high-priced prescription drugs subject to federal price negotiations, taking a swipe at the powerful pharmaceutical industry. It marks a major turning point in a long-fought battle to control ever-rising drug prices for […]

August 29, 2023

The Food and Drug Administration on Monday approved wider use of a drug important to Bristol Myers Squibb’s future, clearing the medicine for people newly diagnosed with a cancer-like disease of the bone marrow. Called Reblozyl, the drug has been […]

August 17, 2023

The road to the U.S. market has been a winding one for Sohonos and Ipsen. Roche originally developed the medicine as a treatment for chronic obstructive pulmonary disease, but it failed in testing. The Canadian biotech Clementia Pharmaceuticals then licensed […]

August 11, 2023

On Aug. 4, 2023, FDA released a guidance document, Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs). The guidance gives both applicants and manufacturers of drugs recommendations for estimating the mutagenic and carcinogenic potential of NDSRIs that could […]

August 9, 2023

The U.S. Food and Drug Administration has approved Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy secondary to age-related macular degeneration. The approval was based on two phase 3 clinical trials, in which patients received 2 mg […]

August 8, 2023

Shares of Sage Therapeutics are worth less than half of what they were late last week, after an approval decision for the company’s most closely watched medicine sharply limited its potential market. On Friday, the Food and Drug Administration cleared […]

August 1, 2023

The acquisition is a quiet end for EQRx, which was launched three years ago by biotech venture capitalist Alexis Borisy and quickly became one of the sector’s most closely watched startups. EQRx formed with an unusual mission to develop lower-cost […]

July 31, 2023

The FDA’s decision means that RiVive stands as the second non-prescription, OTC naloxone nasal spray product that the agency has approved. FDA commissioner, Robert Califf, said: “We know naloxone is a powerful tool to help quickly reverse the effects of […]

July 20, 2023

FDA published a draft guidance document on July 13, 2023 outlining recommendations for manufacturing of products related to human cellular therapy or gene therapy (CGT). Recommendations included product compatibility and manufacturing changes regarding investigational and licensed CGT products. The draft […]

July 20, 2023

On July 17, 2023, FDA approved nirsevimab-alip for newborns and infants born during or entering their first season of Respiratory Syncytial Virus (RSV), and children up to 24 months during their second RSV season who are vulnerable to severe RSV […]

July 19, 2023

The U.S. has long been the most lucrative market for pharmaceutical makers, in part because there are no mechanisms such as price negotiations to control the cost of medicines. As a result, Americans pay more than three times as much […]

July 17, 2023

The drug is already approved in the US to treat COVID-19 in adults and paediatric patients who are hospitalised or have mild-to-moderate COVID-19 and are at high risk for progression to severe illness. However, its use has previously been limited […]

July 13, 2023

The Food and Drug Administration on Thursday approved the first birth control pill to be used without a prescription, potentially expanding access to contraception in the U.S. Called Opill, the once-daily pill will be available over the country in drug, […]

July 7, 2023

The drug, Leqembi (lecanemab-irmb), was authorised for use in patients with mild cognitive impairment (MCI) or early-stage Alzheimer’s disease earlier this year through the accelerated approval pathway, under which the FDA may approve drugs for serious conditions where there is […]

July 5, 2023

A new blood test approved by the U.S. Food and Drug Administration can predict imminent preeclampsia, helping pregnant women who are at risk of this severe and sometimes deadly form of high blood pressure. The test can identify with 96% […]