Category: FDA

May 25, 2023

AbbVie announced on May 19, 2023 that FDA has approved EPKINLY (epcoritamab-bysp), a T-cell engaging bispecific antibody for treating relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The bispecific is particularly indicated for treating adult patients with R/R DLBCL, […]

May 24, 2023

The Food and Drug Administration has delayed its review of a closely watched gene therapy for Duchenne muscular dystrophy by one month, taking more time to consider whether approval should be initially limited to children who are most likely to […]

May 23, 2023

The launch of Ayvakit in indolent systemic mastocytosis, or ISM, is being closely watched by investors and analysts. Blueprint brought two drugs to market in recent years — Ayvakit and the cancer drug Gavreto — and since expanded use of […]

May 19, 2023

The vaccine, if approved, would be the first available for protecting infants from a pathogen that each year kills hundreds of young children. It is one of a recent wave of drugmaker successes against the disease after decades of effort. […]

May 19, 2023

Patients with Crohn’s disease have a new treatment option, following U.S. Food and Drug Administration approval of a pill called Rinvoq (upadacitinib). Rinvoq is meant to treat adults with moderately to severely active Crohn’s disease who have not had success […]

May 18, 2023

While the world may have marched on from the halcyon days of the mid-20th century where the United States was the undisputed center of the global economy, the country’s continual impact should not be understated. Particularly as it concerns the […]

May 17, 2023

Food and Drug Administration scientists reviewing what could become the first medicine for the fatty liver disease NASH are skeptical the treatment’s safety risks outweigh its “modest” benefits, according to documents made public Wednesday. The documents were posted online ahead […]

May 16, 2023

Bayer today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational drug asundexian (BAY2433334) as a potential treatment to prevent stroke and systemic embolism in people with atrial fibrillation (AF). This news […]

May 15, 2023

The U.S. Food and Drug Administration on Friday approved the first nonhormonal medication aimed at easing menopause hot flashes. The new pill, called Veozah (fezolinetant), is a neurokinin 3 (NK3) receptor antagonist. “It works by binding to and blocking the […]

May 11, 2023

Today, the U.S. Food and Drug Administration is announcing the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication. “Agitation […]

May 9, 2023

As a U.S. Food Drug Administration advisory panel prepares to weigh whether to recommend that a birth control pill be sold over the counter in this country, a coalition of advocates on Monday called attention to the safety and effectiveness […]

May 8, 2023

Man’s aging best friend has a new treatment to dull osteoarthritis pain as the U.S. Food and Drug Administration (FDA) announced approval Friday of the first monoclonal antibody for dogs. Called Librela, the bedinvetmab shot controls pain from the most […]

May 2, 2023

FDA released a new draft guidance that provides recommendations aimed at sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. This specific guidance refers to a DCT as a clinical […]

April 28, 2023

While vaccines for the bacterial infection are widely available, thousands of cases still lead to hospitalization and death in the U.S. each year. In response, Pfizer, Merck and others have worked to develop new shots that offer better protection, particularly […]

April 27, 2023

The U.S. Food and Drug Administration on Wednesday approved the first pill form of fecal microbiota — similar to what’s known as fecal transplant therapy — to treat the bacterial infection Clostridioides difficile, one of the most common and deadly […]

April 25, 2023

The Food and Drug Administration has conditionally approved a new ALS medicine in a decision likely to influence how other experimental treatments for the nerve-destroying disease are tested and reviewed. The medicine, known until now as tofersen, is only for […]

April 24, 2023

While it is critically important for the nation’s healthcare system and for biomedical research that the Supreme Court’s recent ruling preserved access to mifepristone (Mifeprex) for now, the emergency action fails to ensure FDA’s long-standing regulatory authority and legal status […]

April 20, 2023

Supreme Court justices could act at any moment on access to the abortion pill mifepristone. Beyond reproductive health, their ruling could carry significant implications for states’ rights and FDA independence and integrity. For now, though, observers are unsure what the […]

April 17, 2023

Today, the U.S. Food and Drug Administration approved Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy to quicken the recovery of neutrophils (a subset of white blood cells) in the body and reduce the risk of infection. […]

April 14, 2023

For a second time, the Food and Drug Administration has rejected Alvotech’s Humira biosimilar, citing deficiencies spotted during a March inspection of its manufacturing facility in Iceland, the company said Thursday. The agency’s decision comes less than three months before […]