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The drug, known as Pemgarda and marketed by the biotech Invivyd, is the first such drug to become available since the agency pulled AstraZeneca’s Evusheld off the market in January 2023. New Omicron variants had rendered Evusheld ineffective. Read the rest…
Food and Drug Administration (FDA) just approved Wezlana (ustekinumab-auub), a biosimilar for the popular drug Stelara. According to the FDA announcement, the most serious side effect of Wezlana is infection because the prescription affects your immune response.
The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firedenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours.
If all goes well, CTP-543 could be ready for filing in early 2023, but even so it looks set to reach the AA market well behind Eli Lilly, which reported positive phase 3 results with its JAK 1/2 inhibitor Olumiant (baricitinib) earlier this year. Both Olumiant and CRP-543 have breakthrough designations from the FDA for this form of alopecia.
Ampio Pharma’s candidate therapy for knee osteoarthritis has been knocked back by the FDA, which will likely now require a new clinical trial of the drug before it will consider a review. The FDA said it should have been advised of the proposed changes before Ampio unblinded and analysed the data from the AP-013 study.
Vitamin D Vitamin D coupons Most people think of vitamin D as the sunshine vitamin without realizing how big of an impact it has on our immune system. Low levels of vitamin D have been linked to poor immune function and fatigue, which can inhibit your recovery from COVID, says Simpson. Who should avoid vitamins for post-COVID fatigue?
In 2023, nine drugs made our annual list of top prescriptions by state, with vitamin D being the most filled. Keep reading to find out which medications were filled with SingleCare the most in your state in 2023. People in the U.S. With two out of five Americans deficient in the nutrient, this ranking makes a lot of sense.
AC Immune SA has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy vaccine candidate for Alzheimer’s disease. The anti-Abeta therapy “specifically targets the most toxic forms of Abeta” according to Dr Andrea Pfeifer, CEO of AC Immune SA.
Food and Drug Administration (FDA) announced its approval of the Boostrix vaccine, commonly known as Tdap (combination of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis) for immunization administration during the third trimester of pregnancy to prevent pertussis in infants younger than two months of age.
Here’s what you need to know about the new FDA-approved RSV vaccine. But young children, older adults, and individuals with weakened immune systems are at high risk of severe, potentially life-threatening RSV illness. The RSV vaccines are not mRNA immunizations, and “they are not live vaccines,” explains Blair Gingerich , Pharm.D.,
Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. Subsection 505(q) initially was added by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub.
However results from that aren’t due to read out until 2023, according to the entry for the study in the clinicaltrials.gov database. It was filed for the adult ALL indication in the US in April, and has a priority review from the FDA, with a verdict due in October. Novartis eyes Yescarta challenge in follicular lymphoma.
Calliditas Therapeutics could have its first product on the market in the US this autumn, as the FDA has now started a priority review of Nefecon for rare disease primary IgA nephropathy (IgAN). . The post FDA sets September review date for Calliditas’ rare kidney disease drug appeared first on.
This will suppress the effector characteristics in multiple immune cell subsets. Tiziana Life Sciences chief medical officer Matthew Davis said: “We anticipate entering into a Phase 2a placebo-controlled clinical trial upon successful feedback from the FDA.
Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision about whether to participate in a clinical trial, and what kind of treatment effects would be most meaningful to them?
Claud — CDER’s Office of Pharmaceutical Quality (OPQ) issued its 2023 Annual Report last week, and it’s an upbeat assessment of the Office’s policy and outreach efforts. Drug shortages have been a scourge for FDA , both as they negatively affect consumers and FDA’s reputation. By John W.M.
While nonbiologic drugs are made with chemicals and have a known structure, most biologics are complex mixtures and cannot be easily identified or characterized, according to the Food & Drug Administration (FDA). Continue reading to learn more about FDA approved Humira biosimilars, which are made by various drug companies.
On November 17, 2022, the FDA approved Provention Bio’s Tzield (teplizumab) , making it the first and only treatment to delay the onset of type 1 diabetes (T1D). These therapies work by reprogramming the immune system, preventing it from attacking and eradicating insulin-producing cells in the pancreas. Equity in early-stage testing.
This decreases the activity of parts of the immune system that are involved in the inflammation of hair follicles that causes hair loss in people with alopecia areata.
In lupus, the body’s immune system starts to attack its own cells. Saphnelo is also being studied in a Phase III trial in lupus nephritis, where a person’s immune system targets the kidneys, eventually leading to kidney failure. Several other investigational therapies are expected to have material updates in 2023.
Tango Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for TNG260 to treat STK11-mutant cancers. It is in preclinical development to reverse immune evasion in STK11 mutated cancers.
Roctavian, an adeno-associated virus (AAV) vector-based gene therapy is the first to be approved by the US Food and Drug Administration (FDA) for adults with severe haemophilia A. The gene therapy is authorised for individuals without pre-existing antibodies to adeno-associated virus serotype 5 detected by an FDA-approved test.
Injectable vaccines activate the immune system to help to prevent infectious conditions such as influenza. In 2023, North America accounted for the biggest market share due the region’s readiness to invest in innovative solutions such as injectable drug delivery systems.
In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa. In December 2023, the FDA granted OCU400 Regenerative Medicine Advanced Therapy (RMAT) designation.
The US Food and Drug Administration (FDA) approved Kamada’s application to manufacture Cytogam (cytomegalovirus immune globulin intravenous [human]) at its facility located in Beit Kama, Israel. It is claimed to be the only immunoglobulin (IgG) product to receive FDA approval for this indication.
Food and Drug Administration (FDA) for Lifileucel. Lifileucel is a tumour infiltrating lymphocyte (TIL) therapy for patients with advanced melanoma who do not respond to immune checkpoint inhibitors. Marc Hurlbert, CEO of the Melanoma Research Alliance (MRA) said he hopes for a quick FDA approval.
Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5 The emergency use approval from the FDA of lipid nanoparticle- (LNP-) based mRNA vaccines during the COVID-19 pandemic attested the significance of LNPs.
Avenge Bio has obtained orphan drug designation from the US Food and Drug Administration (FDA) for its AVB-001 to treat mesothelioma patients. In March 2023, the FDA provided positive feedback on Avenge Bio’s preclinical and clinical development initiatives for pleural malignant mesothelioma.
The FDA has started its review of Pfizer’s respiratory syncytial virus (RSV) vaccine for older adults, fast-tracking the biologics license application (BLA) with a decision due in May 2023. The post RSV vaccine race in balance as FDA sets May date for Pfizer decision appeared first on.
Prednisone is an FDA-approved prescription medication to treat a range of common conditions characterized by inflammation caused by the immune system. Like other steroids, prednisone reduces swelling, redness, and other symptoms caused by immune system reactions.
After earning multimillion dollar revenues while being an authorised preferred treatment for Covid-19, the US Food and Drug Administration (FDA) has granted a full approval to Pfizer’s oral antiviral Paxlovid (nirmatrelvir + ritonavir).
While the French MaaT Pharma has submitted further information to the FDA, its trial remains on hold. In January 2023, Finch announced plans to scrap the PRISM4 trial altogether. In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI. with placebo.
The recent FDA approvals of two microbiome products in the US, in November 2022 and April 2023, 1-2 represent a significant milestone, maturing the industry and paving the way for advancement and regulatory clearance of additional microbiome products in broader indications. Internet] Pharmaceutical Technology. cited 2024Feb].
Pfizer has the FDA approval it was seeking for Prevnar 20, the latest update to its blockbuster pneumococcal vaccination franchise, keeping it one step ahead of a competing shot from Merck & Co. In two phase 3 trials in adults reported last year, V114 stimulated immune responses to all serotypes in the shot.
difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. Notably, gut microbiome was found to linked to cancer CAR T therapy response, based data from the largest prospective study of its kind, published in Nature Medicine in March 2023.
PharmaShots has prepared a list of the top 20 drugs with patent expiry in 2023 Company: Eisai Generic Name: Rufinamide First Approval Date: Nov 17, 2008 Patent Expiration: Apr 2023 2022 Sales: $52M Indication: Lennox-Gastaut syndrome (LGS) Banzel is a prescription add-on drug for the treatment of seizures linked with LGS.
The R21/Matrix-M malaria vaccine, developed by the University of Oxford , has been approved for use in Ghana (13 April 2023) and was authorised for use in Nigeria on 17 April. Granted full national licensure by the country’s Food and Drugs Authority (FDA Ghana), it is authorised for children aged 5 to 36 months.
The FDA has approved a new pneumococcal vaccine from Merck & Co, just over a month after Pfizer got a green light for a new version of its market leading Prevnar shot. Also in the running is Vaxcyte, which has a 24-valent shot in early development and hopes to have initial clinical data from that programme in late 2022/early 2023.
The the first and only treatment indicated to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, budesonide was approved by the FDA in 2021 under the accelerated approval scheme. IgA nephropathy is a chronic immune-mediated kidney disease characterised by IgA deposition in the glomeruli.
Research published in Annals of Oncology in May 2023 showed comparable levels of Tecentriq in the blood when administered subcutaneously. Inhibition of PD-L1 means Tecentriq may enable the activation of T-cells, which support the body’s immune system. The safety and efficacy profile was consistent with the IV formulation.
At the moment, the condition can only be managed using powerful corticosteroid drugs, which suppress the immune system but can have serious side effects if used long-term. If the results are positive, Concert could be ready to file for approval in 2023. All three drugs have breakthrough designations from the FDA for this indication.
At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease-modifying therapy for these patients. It is now in line for a $35 million equity investment by Sanofi following FDA approval.
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