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Category: Regulations


FDA, Regulations

FDA Approves Drug for Cats With Allergic Skin Disease

March 31, 2023

Via: Drugs.com

Cats constantly licking and chewing because of a skin condition called feline allergic dermatitis may benefit from a new generic treatment approved by the U.S. Food and Drug Administration. The FDA approved Modulis for Cats on March 29, making it […]


FDA, Regulations

FDA approves Narcan for over-the-counter use

March 30, 2023

Via: Biopharma Dive

Despite efforts to curb overdoses, the opioid crisis continue to damage communities throughout the country. Overall, opioid deaths in the U.S. were increasing through 2021. Approved since 2015, Narcan has become an important part of the public health response to […]


FDA, Regulations

Bluebird, awaiting FDA feedback, says it’s likely to miss filing goal for sickle cell gene therapy

March 29, 2023

Via: Biopharma Dive

Bluebird is now several months into launching two rare disease gene therapies for which it won FDA approval last fall. But its progress on that front was overshadowed Wednesday by news of the delay for the company’s sickle cell treatment, […]


FDA, Regulations

BrainStorm files ALS drug application over FDA protest

March 27, 2023

Via: Biopharma Dive

A yearslong disagreement between the Food and Drug Administration and a developer of an experimental medicine for ALS will get a public hearing sometime in the future, setting up another high-profile debate of what amount of evidence merits an approval […]


FDA, Regulations

Pharming Gets FDA Nod for Joenja

March 27, 2023

Via: Contract Pharma

Pharming Group N.V. has received approval from the U.S. FDA for Joenja (leniolisib), for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older. Joenjar, an oral, selective PI3Kδ […]


FDA, Regulations

FDA approves new antifungal as concerns grow over drug-resistant fungus

March 23, 2023

Via: Biopharma Dive

Rezzayo is part of a class of medications known as echinocandins, which are usually the first drugs used to treat patients suffering from bloodstream infections caused by Candida. Unlike the three approved medicines in the class, Rezzayo doesn’t require a […]


FDA, Regulations

FDA advisers support conditional clearance of Biogen’s ALS drug

March 22, 2023

Via: Biopharma Dive

The Food and Drug Administration may have an easier time deciding how to approach a closely watched medicine for ALS it is reviewing, after a group of agency advisers appeared to support a conditional approval during a meeting Wednesday. The […]


FDA, Regulations

FDA reversal sets up high-stakes hearing on Sarepta gene therapy

March 17, 2023

Via: Biopharma Dive

Sarepta’s treatment could become the first gene therapy for Duchenne, a devastating genetic disorder for which the biotechnology company has successfully developed three other drugs. The benefit of those medicines is seen as limited at best, however, and they are […]


FDA, Regulations

FDA Seeks $7.2 Billion to Protect and Advance Public Health

March 14, 2023

Via: Biopharm International

On March 9, 2023, FDA announced that it is requesting $7.2 billion as part of the president’s fiscal year 2024 budget. The request includes an increase of $372 million in budget authority and a $150 million increase in user fees. […]


FDA, Regulations

FDA Approves Daybue, the First Treatment for Rett Syndrome

March 14, 2023

Via: Drugs.com

The U.S. Food and Drug Administration has approved Daybue (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients aged 2 years and older. Approval was based on results from the phase 3 LAVENDER study in which the […]


FDA, Regulations

New Nasal Spray for Migraines Approved by FDA

March 13, 2023

Via: Drugs.com

Migraine sufferers will soon have a new treatment option that works more quickly and may be safer for people at risk of heart attack or stroke. The U.S. Food and Drug Administration has approved Pfizer Inc.’s zavegepant (Zavzpret), a nasal […]


FDA, Regulations

FDA advisers back earlier use of Roche lymphoma drug

March 10, 2023

Via: Biopharma Dive

Outside advisers to the Food and Drug Administration have backed expanding use of Roche’s drug Polivy, voting 11-2 Thursday in favor of approving it for patients newly diagnosed with the most common type of non-Hodgkin lymphoma. If the FDA follows […]


FDA, Regulations

Mammogram Centers Must Notify Patients of Breast Density, FDA Says

March 9, 2023

Via: Drugs.com

New U.S. federal regulations will require mammography facilities to tell women if they have dense breasts, a description of how the tissue looks on the X-ray. It can be more difficult to detect cancer in dense breast tissue on a […]


FDA, Regulations

Eli Lilly/Boehringer’s Jardiance for children with type 2 diabetes accepted by FDA

March 9, 2023

Via: PMLiVE

Initially approved in 2014, Jardiance is a once-daily tablet used alongside diet and exercise to lower blood sugar in adults with type 2 diabetes. The drug, however, is not currently indicated for children. Type 2 diabetes most often develops in […]


FDA, Regulations

FDA-Mandated Tweak to Common Rx Painkillers May Have Saved Lives

March 8, 2023

Via: Drugs.com

Acetaminophen, a popular over-the-counter medication for millions struggling with pain and fever, can also be found in prescription painkillers that combine acetaminophen and an opioid into one pill. The problem? The U.S. Food and Drug Administration has long known that […]


Cell and Gene Therapy, FDA, Industry, Regulations

BioMarin, as expected, sees delay to FDA review of hemophilia gene therapy

March 7, 2023

Via: Biopharma Dive

While not surprising, the delay is a disappointment for BioMarin, which has already spent years trying to win U.S. approval of its gene therapy known as Roctavian. The company appeared on track to bring a long-lasting therapy to patients who […]


FDA, Industry, Regulations, Vaccines

FDA approves intramuscular administration of Merck’s MMRV vaccines

March 7, 2023

Via: PMLiVE

Despite having a long history in the US, the vaccines have previously only been administered via subcutaneous injection, which is given into the fatty tissue just under the skin. Now, healthcare professionals will have the option to choose to administer […]


FDA, Regulations

FDA decision on preterm birth drug’s withdrawal nears, putting spotlight on patients, agency

March 6, 2023

Via: Biopharma Dive

Nicole’s first child was born two months early. Pregnant with her second and fearing another preterm labor, she learned of a hormonal shot that could lower her risk. “After I had my first baby, even the people in the [neonatal] […]


FDA, Regulations

FDA Issues Guidance on Potency for mAbs and Therapeutic Proteins

March 3, 2023

Via: Biopharm International

FDA issued guidance on March 2, 2023 to provide recommendations to sponsors that help in the creation of monoclonal antibodies (mAbs) and other therapeutic proteins that target viral proteins or host cell proteins that interfere with pathogenic mechanisms of infection. […]


FDA, Regulations

FDA Panel Backs Pfizer’s RSV Vaccine for Older Americans

March 1, 2023

Via: Drugs.com

In a tight vote, U.S. Food and Drug Administration advisors on Tuesday recommended the approval of an RSV vaccine that could be used in Americans ages 60 and up. The vaccine, known as RENOIR, was developed by pharmaceutical giant Pfizer […]