Search Results for “FDA” – Page 51 – media

Neuralink competitor Paradromics gets one step closer to FDA approval for its brain implant

A growing team of nearly 50 employees at the neurotech startup Paradromics is working on a brain implant that sounds like the work of science fiction. And it has caught the attention of federal regulators. Paradromics, founded in 2015, is developing a device that could help patients with severe paralysis regain their ability to communicate by deciphering their neural signals. And on Thursday, the Austin, Texas-based company announced that it has received the Breakthrough Device designation from the Food and Drug Administration for its flagship system, called the Connexus Direct Data Interface. CEO Matt Angle said the designation, in addition to a $33 million funding round the company also announced Thursday, will help Paradromics bring its device to market. Paradromics is part of the emerging brain-computer interface, or BCI, industry. A BCI is a system that deciphers brain signals and translates them into commands for external technologies. Experts believe the ...
- Source: drugdu
- 120
- May 21, 2023
AbbVie nabs seventh FDA approval for Rinvoq, adds Crohn’s disease indication

Beth Snyder Bulik Senior Editor AbbVie picked up another indication for blockbuster Rinvoq on Thursday, this time for Crohn’s disease. The seventh FDA approval for the JAK inhibitor is specifically for use in moderate to severe Crohn’s patients who have had inadequate response or intolerance of at least one TNF blocker. While there are several other biologics already on the market to treat moderately to severely active Crohn’s including J&J’s Stelara, Takeda’s Entyvio and AbbVie’s own Skyrizi, the FDA noted that Rinvoq is the first oral drug. The approval was based on results from three studies, the U-EXCEED and U-EXCEL initial trial and the U-ENDURE maintenance trial, determining statistical significance in the co-primary endpoints of endoscopic response and clinical remission. AbbVie consultant and gastroenterologist Edward Loftus, who was a U-EXCEL investigator, said in a news release, “Based on the clinical trial results, treatment with RINVOQ shows both early and long-term ...
- Source: drugdu
- 119
- May 21, 2023
Abbott wins FDA spinal cord stimulation approval to challenge Nevro for back pain market

Dive Brief The U.S. Food and Drug Administration has approved Abbott’s spinal cord stimulation devices for the treatment of non-surgical back pain. Abbott landed the label expansion after showing its BurstDR spinal cord stimulation technology improved outcomes more than conventional medical management in people with chronic back pain who were ineligible for surgery. The label expansion comes 16 months after Nevro won FDA approval in non-surgical refractory back pain and four months after Boston Scientific released data on its rival device in the setting. Dive Insight: Abbott competes with Boston Scientific, Medtronic and Nevro for the spinal cord stimulation market and the four players are continually looking to expand into new areas where they are free from the intense competition that characterizes the core indications. Nevro unlocked an opportunity early last year, when it said it was the only company with specific labeling to treat non-surgical refractory back pain. Now, ...
- Source: drugdu
- 131
- May 20, 2023
US Appeals Court Panel Questions FDA Due Diligence on Abortion Pill

By Lisa Munger Pictured: Scales of justice/Kanizphoto, iStock A three-judge panel in Louisiana’s 5th Circuit Court of Appeals proffered probing questions during oral arguments Wednesday about whether the FDA had done due diligence before it made changes in recent years that made the abortion pill, mifepristone, more accessible. This comes after the U.S. Supreme Court granted the FDA’s application for a stay in April, effectively maintaining access to mifepristone as the case goes through the appeals process. Anti-abortion groups sued the FDA in November 2022, arguing that its approval of mifepristone in 2000 was flawed and subsequent changes to its usage lacked solid scientific evidence. The three-judge panel, consisting of Jennifer Walker Elrod, James C. Ho and Cory T. Wilson, raised questions about the FDA’s role in reviewing and approving medications during Wednesday’s hearing. “I don’t understand this theme [that] ‘the FDA can do no wrong.’ That is basically the narrative ...
- Source: drugdu
- 104
- May 20, 2023
FDA clears insertable cardiac monitor from Abbott

Abbott (NYSE:ABT) today announced that it received FDA clearance for its Assert-IQ insertable cardiac monitor (ICM). The Assert-IQ device offers a new option for diagnostic evaluation and long-term monitoring for irregular heartbeats. It supplements Abbott’s portfolio of connected health devices for managing and treating patients remotely. The device could potentially rival the Medtronic Linq system. A small device with sensors inserted just under the skin of the chest, Assert-IQ provides constant, real-time monitoring. It can detect and identify arrhythmias that lead to symptoms like fainting, irregular pulse and shortness of breath. Abbott says many commercially available ICMs monitor hearts for “a few years,” but Assert-IQ offers two options. With a battery life of at least three or six years, it can provide doctors with a new level of flexibility in diagnostic monitoring. The three-year option offers a method for more traditional monitoring. That includes diagnosing fainting, heart palpitations or abnormal ...
- Source: drugdu
- 115
- May 20, 2023
FDA advisors recommend Pfizer’s RSV vaccine for infants but raise safety concerns

The U.S. Food and Drug Administration’s independent panel of advisors Thursday recommended full approval of Pfizer’s vaccine that protects infants from respiratory syncytial virus, but raised safety concerns over premature births that may be tied to the shot. The committee unanimously said the vaccine efficacy data was sufficient. Ten of the advisors said the safety data on Pfizer’s shot was adequate, while four said it was not. “If the vaccine actually lives up to the data we’ve seen today, I can guarantee many infants and their parents will breathe easier in the coming years,” said Dr. Jay Portnoy, medical director at the Children’s Mercy Hospital in Kansas City, after voting in favor of the safety and efficacy of the shot. Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, said he doesn’t believe there is enough data that indicates the safety of the vaccine is “reassuring.” “If ...
- Source: drugdu
- 111
- May 20, 2023
Intercept’s latest NASH bid in jeopardy after FDA questions drug’s efficacy, safety

An industry-first FDA approval for a nonalcoholic steatohepatitis (NASH) therapy may still be a ways off.After reviewing Intercept Pharmaceuticals’ latest application for obeticholic acid (OCA), the agency appears all but ready to reject the drug in NASH-related pre-cirrhotic liver fibrosis, according to a briefing document released ahead of an expert panel meeting set for Friday. Citing a long list of safety risks and the practical hurdle for patients to undergo a liver biopsy—coupled with “modest” efficacy—the FDA said it “cannot justify OCA use in NASH subjects with stage 2 or 3 fibrosis.” The FDA’s negative review could once again thwart Intercept’s bid to win the first NASH approval in the U.S. If members of the FDA’s Gastrointestinal Drugs Advisory Committee side with the FDA and the agency follows through with its own staff’s analysis, it would mark the second rejection for OCA in NASH. Intercept’s stock price was down more ...
- Source: drugdu
- 139
- May 19, 2023
Allergan’s new skin-smoothing product gets FDA nod—with novel delivery mechanism

AbbVie’s aesthetics unit is growing its product catalog once again with a new FDA approval.The product, called Skinvive, nabbed an FDA nod this week and falls within Allergan’s Juvederm dermal filler collection. Skinvive works by injecting hyaluronic acid (HA), plus a small amount of lidocaine, into facial skin to increase hydration while smoothing. The delivery mechanism is the first of its kind and “flows easily into the skin,” creating a “lasting glow,” Allergan said in a recent release. Skinvive got the green light for use in adults over the age of 21 with all Fitzpatrick skin types I-VI covered, a skin classification scale that ranges from light to dark. Its effects last six months and the procedure requires little to no downtime, according to the company. The approval was supported by a pivotal clinical study in which 58% of patients saw their skin improve by more than one point on ...
- Source: drugdu
- 116
- May 19, 2023
`FDA advisory committee backs Sarepta’s Duchenne muscular dystrophy gene therapy

A US Food and Drug Administration’s (FDA) panel of experts has recommended Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) investigational gene therapy for accelerated approval. The Cellular, Tissue and Gene Therapies advisory committee voted eight to six in support of SRP-9001 (delandistrogene moxeparvovec) as a treatment for ambulatory DMD patients with a confirmed mutation in the DMD gene. DMD is a rare and inherited X-chromosome-linked disease that results in the lack of dystrophin protein, which is required to strengthen and protect muscles. Over time, this causes progressive loss of muscle strength, with most patients requiring full-time use of a wheelchair by their early teens. Eventually, increasing difficulty in breathing due to respiratory muscle dysfunction requires ventilation support, and cardiac dysfunction can lead to heart failure. The disease almost exclusively affects males, occurring in approximately one in every 3,500-5,000 newborn males worldwide. SRP-9001 is designed to address the underlying cause of DMD ...
- Source: drugdu
- 107
- May 18, 2023
Pfizer’s maternal RSV vaccine effective at preventing severe infections in newborns, FDA says, but flags potential risk of preterm birth

By Brenda Goodman, CNN CNN — Pfizer’s vaccine to protect newborns from respiratory syncytial virus, or RSV, by vaccinating their moms late in pregnancy cuts the risk that infants will need to see a doctor or be admitted to the hospital with a moderate to severe infection before 6 months of age, according to a new analysis by government regulators. Many parents have been eagerly anticipating this news, particularly after last year’s long and severe RSV season. RSV is a major cause of hospitalization in infants and the elderly each year, and it typically hits hardest during the winter months. Scientists have been working on an effective RSV for young children for roughly 60 years, so there’s plenty of excitement around the prospect of having a candidate get so close to the finish line. But the news isn’t all rosy. Safety data published in an agency analysis Tuesday also showed ...
- Source: drugdu
- 130
- May 18, 2023

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