Category: Regulations

July 26, 2024

A Federal Register notice issued by FDA on July 24, 2024, entitled “Biosimilar Product Development Guidance; Establishment of a Public Docket; Request for Information and Comments,” seeks input from interested parties as to whether biosimilar product development would be better […]

July 23, 2024

Pharmacist Mark Mikhael has lost 50 pounds over the past 12 months. He no longer has diabetes and finds himself “at my ideal body weight,” with his cholesterol below 200 for the first time in 20 years. “I feel fantastic,” […]

July 19, 2024

The U.S. Food and Drug Administration on Thursday authorized the sale of the country’s best-selling e-cigarette. The agency’s decision only applies to several tobacco-flavored versions of the reusable product, sold as Vuse. In January 2023, the FDA rejected R.J. Reynold’s […]

July 11, 2024

Novo is one of the world’s premier manufacturers, along with Indianapolis-based Eli Lilly. Both have been working for years to offer patients a more convenient option than the once-daily injections of insulin that many diabetics require. Lilly in May announced positive […]

July 11, 2024

The FDA sent the Danish drugmaker a complete response letter (CRL) declining to approve the drug, insulin icodec, saying that it needs more information on its manufacturing process, as well as more data on how well it performs in people with […]

July 3, 2024

The US regulator has cleared donanemab as Kisunla for use in patients with mild cognitive impairment or the mild dementia stage of Alzheimer’s with confirmed amyloid plaques, becoming the third drug in the class after Eisai/Biogen’s short-lived Aduhelm (aducanumab) and current rival Leqembi (lecanemab). The Alzheimer’s […]

July 2, 2024

For patients with gout who cannot get relief using standard therapies, daily life can be a painful, debilitating experience. The disease is a painful form of inflammatory arthritis caused by elevated levels of uric acid in the blood resulting in […]

June 27, 2024

On June 24, 2024, FDA posted a conversation on its website with Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs, regarding the progress of the modernization of the New Drug Regulatory Program (NDRP). […]

June 24, 2024

The FDA has given accelerated approval to Krazati (adagrasib) as a combination with Eli Lilly’s anti-EGFR-antibody Erbitux (cetuximab) to treat patients with KRAS G12C-mutated, locally advanced, or metastatic CRC who have previously received chemotherapy. At the moment there are two KRAS inhibitors on the […]

June 21, 2024

FDA published a final guidance document on June 18, 2024 that provides applicants with information on FDA’s policy for assigning a goal date for a facility’s inspection readiness as certified on Form FDA 356h, submitted as part of an original […]

June 20, 2024

The Food and Drug Administration has substantially loosened limits on the first gene therapy for Duchenne muscular dystrophy in a decision that could greatly expand its use even as questions remain about its effectiveness. The agency on Thursday made the therapy, called […]

June 19, 2024

Affecting more than one million people in the US, UC is a type of inflammatory bowel disease (IBD) that causes inflammation in the digestive tract and can result in damage to the colon lining. Patients often experience a range of […]

June 18, 2024

Global healthcare company, Grifols, announced on June 17, 2024 that its subsidiary Biotest has garnered its first FDA approval with the intravenous immunoglobulin (Ig) therapeutic, Yimmugo, which Grifols hopes to launch commercially in the United States in the second half […]

June 18, 2024

The clearance covers Roche’s Ventana DP 200 slide scanner, digital pathology workflow software, and a display that can be used to review and interpret digital images of scanned pathology slides. Proponents of digital pathology technologies say that having this image data in […]

June 17, 2024

The therapy has been authorised for use in patients with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukaemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status. With more than 6,500 new cases diagnosed in the US […]

June 14, 2024

COVID vaccine makers will be advised to update their shots to target the KP.2 variant, an offshoot of the JN.1 variant that spread widely last winter, the U.S. Food and Drug Administration announced Thursday. It’s a turnaround for the agency: […]

June 14, 2024

Augtyro (repotrectinib), which first got a green light from the FDA as a treatment for ROS1-positive non-small-cell lung cancer (NSCLC) last November, has now had its label extended to include all solid tumours that have NTRK gene fusions. The NSCLC approval was […]

June 11, 2024

A U.S. Food and Drug Administration advisory panel voted unanimously on Monday to recommend that the benefits of a new drug for Alzheimer’s outweigh its harms, which can include brain swelling and bleeding. Eli Lilly’s donanemab did slow declines in thinking skills […]

June 10, 2024

The U.S. Food and Drug Administration on Friday has for the first time approved the use of a respiratory syncytial virus (RSV) vaccine for people in their 50s who are at increased risk for the illness. Drugmaker GSK’s Arexvy vaccine, […]

June 10, 2024

First approved in 2020, first-in-class microtubule inhibitor Klisyri (tirbanibulin 1%) reached the market in early 2021, joining a short list of therapies in the US that are available for AK, which is a major public health concern as it can […]