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Tag: FDA


FDA, Regulations

FDA Allows Marketing of Vuse Tobacco-Flavored Vapes

July 19, 2024

Via: Drugs.com

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 […]


FDA, Regulations

Novo’s once-weekly insulin rejected by FDA

July 11, 2024

Via: Biopharma Dive

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 […]


FDA, Regulations

FDA rejects Novo Nordisk’s weekly basal insulin

July 11, 2024

Via: Pharmaphorum

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 […]


FDA, Regulations

Lilly gets FDA OK for Alzheimer’s drug, cites cost advantage

July 3, 2024

Via: Pharmaphorum

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 […]


FDA, Regulations

Sobi starts rolling FDA filing for chronic gout drug

July 2, 2024

Via: Pharmaphorum

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 […]


FDA, Regulations

FDA Provides Update on New Drugs Regulatory Program

June 27, 2024

Via: Biopharm International

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). […]


FDA, Regulations

BMS gets FDA approval for Krazati in colorectal cancer

June 24, 2024

Via: Pharmaphorum

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 […]


FDA, Regulations

FDA Releases Facility Readiness Guidance

June 21, 2024

Via: Biopharm International

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 […]


News

AbbVie breaks new ground for IL-23 drug Skyrizi in IBD

June 20, 2024

Via: Pharmaphorum

Skyrizi (risankizumab) was previously already cleared by the FDA for adults with moderately to severely active Crohn’s disease, active psoriatic arthritis, and moderate to severe plaque psoriasis. The approval in UC is based on the results of a 12-week induction study called […]


Cell and Gene Therapy, FDA, Industry, Regulations

Sarepta Duchenne gene therapy wins broader use from FDA

June 20, 2024

Via: Biopharma Dive

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 […]


FDA, Regulations

AbbVie’s IL-23 inhibitor Skyrizi approved by FDA to treat ulcerative colitis in adults

June 19, 2024

Via: PMLiVE

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 […]


FDA, Regulations

FDA Approves Immunoglobulin Therapeutic to Treat Primary Immunodeficiencies

June 18, 2024

Via: Biopharm International

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 […]


FDA, Regulations

FDA clears Roche digital pathology platform for diagnosis

June 18, 2024

Via: Pharmaphorum

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 […]


FDA, Regulations

Amgen’s Blincyto approved by FDA for new acute lymphoblastic leukaemia indication

June 17, 2024

Via: PMLiVE

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 […]


FDA, Industry, Regulations, Vaccines

FDA Tells Vaccine Makers to Target New COVID Variant for Fall

June 14, 2024

Via: Drugs.com

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: […]


FDA, Regulations

FDA widens label for BMS’ cancer drug Augtyro

June 14, 2024

Via: Pharmaphorum

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 […]


FDA, Regulations

FDA Advisors Support New Alzheimer’s Drug, Donanemab

June 11, 2024

Via: Drugs.com

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 […]


FDA, Industry, Regulations, Vaccines

FDA Gives Nod to RSV Vaccine for People in Their 50s

June 10, 2024

Via: Drugs.com

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, […]


FDA, Regulations

FDA OKs wider use of Almirall’s actinic keratosis drug

June 10, 2024

Via: Pharmaphorum

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 […]


FDA, Regulations

With Bird Flu a Threat, FDA Asks Some States to Curb Sales of Raw Milk

June 7, 2024

Via: Drugs.com

The U.S. Food and Drug Administration on Thursday asked states to work harder to protect the public from the risks of raw milk as a bird flu outbreak continues to spread among dairy cows. In an open letter to state […]