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While the government said that Gilead secured its PrEP approvals only after CDC’s research on the topic, the company stated that there already were published materials on the potential use of antiretroviral therapies as PrEP prior to this. Gilead markets both Truvada and its successor Descovy.
Food and Drug Administration has authorized the marketing of 20 ZYN nicotine pouch products. Nicotine pouchessmall synthetic fiber pouches containing nicotineare designed to be placed between a person's gum and lip. Following an extensive scientific review, the U.S.
Indicated for the treatment of trichomoniasis in adults, amebiasis in both adults and pediatric patients and anaerobic bacterial infections in adults, Likmez is available as an oral suspension, with each 5 mL containing 500 mg of metronidazole.
Wainua is the only FDA-approved drug for the treatment of ATTRv-PN that can be self-administered via an auto-injector. Approval of Wainua represents a meaningful advancement in treatment, one that gives those who are living with transthyretin-mediated amyloid polyneuropathy help managing the disease,” said Michael J.
And in another first, VBI’s shot is the only approved three-antigen HBV vaccine for adults in the US. PreHevbrio contains the S, pre-S2 and pre-S1 HBV surface antigens. Prior to the FDAapproval, PreHevbrio was only approved in Israel. percent from 2019 to 2026 and hit a market value of $2.13
The headlines read “FDAapproves obesity drug that helped people cut weight 15%” But buyer beware. Wegovy also contains warnings for pancreatitis, gallbladder problems including gallstones, low blood sugar, acute kidney injury, eye retina damage, increased heart rate, and suicidal behavior or thinking.
The biotherapeutics market is rapidly growing, with 2021 seeing the highest-ever cell and gene therapy approval number. The first FDA-approved gene therapies (Luxturna and Kymriah) entered the market in 2017. The future of cell and gene therapies. Collaboration and integrated manufacturing.
has received US Food and Drug Administration (FDA) approval for treating molluscum contagiosum in adult and pediatric patients aged two years and older in the US. Formerly known as VP-102, Ycanth is the first cantharidin formulation approved for this purpose. ’s berdazimer gel, containing 10.3
Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC). The post J&J files lung cancer bispecific amivantamab for FDAapproval appeared first on.
It has been five years since the first biosimilar launched in United States market—marking the first steps in expanding access to innovative biologic-based treatments that help patients manage and treat difficult illnesses such as cancer, rheumatoid arthritis, and other life-altering diseases. million patients.
Blenrep (belantamab mafodotin) has been approved in patients who have received at least four therapies including an anti-CD38 such as Darzalex, a proteasome inhibitor and an immunomodulatory agent. The post FDAapproves GSK’s Blenrep for advanced multiple myeloma appeared first on. of patients in the cohort.
Containing cancer and killing those abnormal cells without damaging nearby healthy cells often requires a range of treatments over an extended period of time — lengthy radiation, complicated surgeries, costly chemotherapy, plus other strong medications to supercharge your immunity. What makes cancer such a financial killer? ScienceNews.com.
FDA’s Green Flag to Keytruda and Lenvima combination by Merck and Eisai for Advanced renal cell carcinoma (RCC). The FDAapproved the combination of Keytruda and Lenvima produced by Merck and Eisai, as a first-line treatment of adult patients with advanced renal cell carcinoma (RCC). The rarity of disease – 1.36
“We evaluated the reconsideration petition and concluded that it does not provide a basis for modifying the FDA’s response to the original citizen petition,” the FDA said in a constituent update. Among the plethora of phthalates available on the market, ortho-phthalates are the most prevalent.
Moreover, samples for the SalivaDirect test can be collected in any sterile container, and hence does not require any specific type of swab or collection vessel, making collection quick and easy. Last month, the FDAapproved a pooled test for COVID-19 developed by Quest Diagnostics. And now it’s getting approval.
For years, Jazz Pharmaceuticals has dominated the market in treating narcolepsy with cataplexy. Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDAapproval in 2002.
The US Food and Drug Administration (FDA) has given the green light to Femlyv , a combination oral contraceptive containing norethindrone acetate and ethinyl estradiol. Norethindrone acetate and ethinyl estradiol are legacy drugs that have been approved since 1968 in a swallowable tablet form for the prevention of pregnancy.
Related: Nestlé to Market Seres’ Oral Microbiome Drug for C. As the first FDA-approved fecal microbiota product, (the) action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” said Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER).
Established in 1990 with the passage of the Safe Medical Devices Act, the program creates an alternative pathway for marketapproval of medical devices that may help people with rare diseases or conditions. The FDA should respond to the request within 45 days. Criteria to Obtain the Benefit. Author: Marissa Berry, PhD, RAC.
There are several therapies in the market to address the Myasthenia Gravis burden, and many companies are still working on their drug candidates to cope with Myasthenia Gravis. Myasthenia Gravis Approved Therapies. The current Myasthenia Gravis therapeutics market has many FDA-approved drugs for the treatment of Myasthenia Gravis.
per unit, included 958,903 units, each containing one ordinary share and three warrants to purchase additional shares at an exercise price of $4.38 Trading began on the Nasdaq Capital Market under the ticker “PLRZ” on October 29, 2024. Polyrizon Ltd., million in gross proceeds. The IPO, priced at $4.38 Polyrizon Ltd.
In addition, as part of the label update, this indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy.
Airsupra (PT027), a new asthma rescue treatment developed by AstraZeneca (AZ) and development partner Avillion, has been approved by the US Food and Drug Administration (FDA). Additionally, under its 2018 agreement, Avillion had regulatory responsibility, including filing the New Drug Application (NDA) through to FDAapproval.
a Texas-based pharmaceutical firm specializing in psychotropic drug development, revealed that its groundbreaking antidepressant, Exxua (gepirone extended release) for treating major depressive disorder (MDD), received US Food and Drug Administration (FDA) approval on September 22, 2023. Fabre Kramer Pharmaceuticals, Inc.,
Adzynma is a an ERT containing purified recombinant form of the ADAMTS13 enzyme administered to boost levels of the deficient enzyme in patients with cTTP. Today, we are proud to further support the rare disease community by delivering Adzynma as the first FDA-approved therapeutic option for people with cTTP.”
When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning.
The US Food and Drug Administration (FDA) granted approval to AstraZeneca’s Airsupra (albuterol/budesonide), formerly known as PT027, for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of asthma attacks in individuals aged 18 years and older who have asthma.
The sale of an illegally imported supplement being marketed as a weight-gain enhancer has been associated with cases of dizziness, cognitive impairment, and sedation, according to the US Food and Drug Administration (FDA).
The idea behind these treatments relies on altering the gut microbiome by designing therapeutics that contain bacteria derived from donated stool samples. In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI.
The FDAapproval of Izervay is great news for the retina community and our patients suffering from geographic atrophy,” said Arshad M. Izervay contains avacincaptad pegol sodium, an effective complement C5 inhibitor. How Does Izervay Work?
The purpose of a CPAM is to address the standards and requirements for marketing authorization of a combination product and other issues relevant to a combination product, such as requirements related to postmarket modification of the product or CGMPs. Approval of the Month: FDA Clears Orladeyo from Biocryst Pharmaceuticals.
Pink Sauce, a product created and marketed by a woman who goes by Chef Pii on TikTok, has gone viral for all the wrong reasons. Yet over the past few weeks, she’s faced numerous questions about Pink Sauce’s ingredients, packaging and marketing, prompting a social media-based food scandal. FDA-Approved?
Posluma is now the first and only radiohybrid PSMA-targeted PET imaging agent to receive FDAapproval. Posluma contains a radioactive imaging agent, fluorine-18 ( 18 F), that is designed to specifically bind to the PSMA over-expressed on prostate cancer cells. billion by 2030, according to a report by Global Market Insights.
Still, Blank suggested that companies enroll the patient population that is most likely to benefit, because early phase studies contain the most safety risks. One such example is Hemgenix (etranacogene dezaparvovec), the first gene therapy to treat adults with haemophilia B, which was approved in November.
If you are facing an FDA remote review, Camargo can help design a comprehensive approach in order to avoid such pitfalls. Approval of the Month: Alnylam to Use Value-Based Agreements for Ultra-rare Disease Treatment. Without that showing, the FDA is directed to revoke the exclusivity. Evergreening Orphan Drugs May Be Over.
The product is food-grade, non-stick, chemical-free and made of a high-performance FDA-approved silicone material. In other words, this product disrupts the market by introducing an all-in-one cookware item. She says, “You can prep, cook, eat, store, and reheat in the same container without having to transfer food over and over.
FDAApproves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. It’s very exciting to see this treatment go from being an experimental therapy used at my daughter’s bedside to now being FDAapproved. NEW YORK, Nov. 25, 2020 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics, Inc.
Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDAapproval, the U.S.
The pipeline for dry eye disease drugs is beginning to heat up, with two biotechs announcing key developments, aiming to disrupt a market led by Allergan and Novartis. billion for its FDA-approved dry eye drug Xiidra during the Japanese pharma’s merger with Shire in 2019, outlining the sales potential in this market niche.
Amazon is advancing into healthcare on multiple fronts, launching its own pharmacy business for medicines delivery in the US last year, whilst also entering the health wearables market with its own Halo device, and bolstering the health-related capabilities of its Alexa virtual assistant.
Tirzepatide is a novel investigational obesity treatment that contains mimetics of two hormones that are involved in regulating appetite in a single peptide: a GIP (glucose-dependent insulinotropic polypeptide) receptor agonist and a GLP-1 (glucagon-like peptide-1) receptor agonist. percent and 22.5 percent, respectively, compared to placebo.
The market for hemp beverages has been growing rapidly in recent years. The passing of the 2018 Farm Bill, which legalized hemp production, boosted the market, allowing companies to explore hemp as a primary ingredient. This ruling, dated May 15, 2024, is only the 15th such declaration by the agency since 2010.
FDAApproves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Klisyri is the first FDAapproved branded proprietary product for Athenex and will be launched in partnership with Almirall in the U.S. The FDAapproval of Klisyri is a significant milestone for Athenex. “The
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