XTalks

OCTOBER 29, 2024

Iterum Therapeutics has won approval from the US Food and Drug Administration (FDA) for Orlynvah (oral sulopenem) to treat uncomplicated urinary tract infections (uUTIs) caused by E. The FDA nod marks the first approved product for Iterum and the first approved indication for Orlynvah.

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Pharmaceutical Technology

MAY 18, 2023

Biotechnology company Lumen Bioscience has secured fast track designation from the US Food and Drug Administration (FDA) for LMN-201 for the treatment and prevention of C difficile infection (CDI). It is compatible with standard-of-care antibiotics. Pivotal trials on LMN-201 are expected to commence in 2023. “We

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XTalks

JULY 6, 2021

to jointly commercialize the company’s investigational oral microbiome drug for recurrent Clostridioides difficile infection (CDI) in the US and Canada. The deal involved Nestlé gaining commercialization rights outside of the US and Canada for four experimental drugs: Seres’ SER-287 and SER-301 for irritable bowel disease and SER-262 for C.

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XTalks

AUGUST 2, 2022

On July 27, 2022, GSK announced that the US Food and Drug Administration (FDA) has approved Benlysta (belimumab) as an intravenous treatment for lupus and active lupus nephritis (LN) in children between the ages of 5 and 17 who are receiving standard therapy. When this behaviour is prolonged, it results in inflammation.

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XTalks

MAY 31, 2022

The spotlight for plaque psoriasis treatment is now on Vtama (tapinarof) cream (one percent), Dermavant’s discovery that has become the first steroid-free topical medication in its class approved by the US Food and Drug Administration (FDA). The Chemical Composition of Vtama. There is 10 mg of tapinarof per gram of Vtama cream.

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The Pharma Data

NOVEMBER 2, 2020

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder.

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XTalks

MAY 31, 2024

Allecra Therapeutics, a clinical-stage biopharma company focused on combating antibiotic resistance, received approval from the US Food and Drug Administration (FDA) for Exblifep (cefepime/enmetazobactam). cUTIs often require broad-spectrum antibiotics to effectively eradicate bacteria in the urinary tract.

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The Pharma Data

JULY 23, 2021

Food and Drug Administration (FDA) approved DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. AbbVie (NYSE: ABBV) today announced that the U.S. This analysis evaluated an early clinical response at 48 to 72 hours based on achieving a ?

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XTalks

AUGUST 9, 2023

a leader in developing therapeutic solutions for common diseases with limited treatment alternatives, has secured approval from the US Food and Drug Administration (FDA) for its drug, Xdemvy (lotilaner ophthalmic solution) 0.25%. California-based Tarsus Pharmaceuticals Inc.,

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Delveinsight

NOVEMBER 26, 2020

The drug did not do any better than a generic control in a phase 3 trial in overactive bladder patients. However, Urovant progressed quickly for filing for FDA approval earlier this year in a bid to set vibegron as a rival to beta-3 agonist Myrbetriq of Astellas. Clancy, M.D.,

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XTalks

JUNE 1, 2022

BONESUPPORT received market authorization from the FDA for Cerament G, the first and only bone graft with antibiotic elution that is approved for the US market. Osteomyelitis is a bone infection caused by fungi or bacteria. What was special about this latest FDA approval from the company’s (BONESUPPORT’s) commercial perspective?

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XTalks

MAY 17, 2024

Eli Lilly announced it has reached a settlement with a medical spa selling counterfeit versions of the company’s blockbuster tirzepatide GLP-1 drugs Mounjaro and Zepbound. Given the relentless high demand for the drugs, both Novo and Lilly’s GLP-1 products remain on the FDA’s Drug Shortages list since the end of 2022.

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pharmaphorum

APRIL 26, 2022

The treatment has been granted US FDA breakthrough therapy designation and orphan drug designation, and has also completed a phase 3 clinical study. The biotech is eligible to receive a further $125 million if the FDA approves the drug and could receive another $225 million in commercial milestones.

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The Pharma Data

JULY 29, 2021

Food and Drug Administration (FDA) has approved a label expansion of BOTOX ® to include eight new muscles for the treatment of upper limb spasticity in adults. BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. million adults in the U.S.

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The Pharma Data

JULY 12, 2021

online issue of Nature Communications, researchers at University of California San Diego School of Medicine describe a new approach that uses machine learning to hunt for disease targets and then predicts whether a drug is likely to receive FDA approval. the success rates in drug discovery?are

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The Pharma Data

DECEMBER 15, 2020

Many drug makers are investing in new science and hope to develop new therapeutics that address autoimmune disease. Scientists will be testing a drug class targeting the C-reactive protein (CRP) marker of acute inflammation in the body. They’ll use software that searches available drugs, as well as drug-like compounds.

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XTalks

DECEMBER 12, 2023

After receiving US Food and Drug Administration (FDA) approval for Fabhalta (iptacopan) last week for the treatment of the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH), Novartis presented trial data yesterday showing the drug’s promise in another indication.

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XTalks

JUNE 21, 2024

The US Food and Drug Administration (FDA) has green-lighted the first pneumonia vaccine specifically designed for adults 50 years of age and older.

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The Pharma Data

SEPTEMBER 8, 2021

About BOTOX ® BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. In children being treated for urinary incontinence, other side effects include urinary tract infection and bacteria in the urine. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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The Pharma Data

SEPTEMBER 10, 2021

About BOTOX ® BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. In children being treated for urinary incontinence, other side effects include urinary tract infection and bacteria in the urine. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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XTalks

DECEMBER 2, 2022

Swiss company Ferring Pharmaceuticals has won a historic approval from the US Food and Drug Administration (FDA) for its fecal transplant-based therapy Rebyota (fecal microbiota, live-jslm) to reduce the recurrence of bacterial infection. The therapy is the first of its kind to be approved in the US. Difficile. “As

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XTalks

APRIL 12, 2021

In 2019, Xtalks profiled six Parkinson’s biotech companies that were leading the way in disease research and drug development. In July of 2019, PR001 was granted Fast Track Designation from the US Food and Drug Administration (FDA), and the company’s composition of matter patent for PR001 was approved in November 2020.

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pharmaphorum

JULY 2, 2021

Swiss food giant Nestle has firmed up its five-year-old alliance with US microbiome specialist Seres, paying $175 million upfront for North American co-marketing rights to its lead drug for Clostridium difficile infections. diff drug appeared first on. diff infection. diff, which can germinate and grow after the course is completed.

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pharmaphorum

AUGUST 28, 2020

Shares in dermatology specialist Cassiopea, which is listed on the SWX exchange in Switzerland, rose almost 17% after news of the FDA approval emerged. Retinoids can help unclog pores, while antibiotics can limit the growth of bacteria. The post FDA hands Cassiopea its first approval, for acne drug Winlevi appeared first on.

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The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics. The FDA, an agency within the U.S. Food and Drug Administration. .

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The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

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pharmaphorum

OCTOBER 27, 2022

If approved, SER-109 would be the first-ever FDA-approved oral microbiome therapeutic. Additionally, SeresTx’s BLA has been granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) target date of 26 th April 2023. difficile infection by repairing the microbiome.

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Roots Analysis

JANUARY 14, 2024

With the increased interest and gradual shift of investment from small molecule drugs to biologics and the establishment of several biologics manufacturing companies / biologics CMOs, more than 250 biologic therapies and vaccines have been developed, globally. Like all drugs, biologics are regulated by the FDA.

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Delveinsight

DECEMBER 18, 2020

Brain infection from parasites (malaria, neurocysticercosis), viruses (influenza, dengue, Zika), and bacteria. Drug or alcohol abuse. Drugs and medications can control Epilepsy. The first step towards managing a seizure is to prescribe Anti-epileptic drugs (AEDs) , which help in reducing the number of seizures.

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XTalks

DECEMBER 22, 2021

At the beginning of the year, Genentech, a member of the Roche Group, struck a deal with Ribometrix to leverage its discovery platform to discover, develop and commercialize small molecule drug candidates against RNA targets. The deal could bring the North Carolina-based RNA-based small molecule therapeutics developer more than $1 billion.

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XTalks

AUGUST 2, 2023

Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. Pfizer’s total global revenue in 2022 from Comirnaty was $37.81

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) approved VAXNEUVANCE ™ (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.

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The Pharma Data

APRIL 3, 2021

Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for upadacitinib in the treatment of adults and adolescents with moderate to severe atopic dermatitis. The Prescription Drug User Fee Act (PDUFA) action date has been extended three months to early Q3 2021.

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XTalks

OCTOBER 14, 2022

This week, GSK announced in a press release that the US Food and Drug Administration (FDA) had approved Boostrix as an immunization for pregnant women for the prevention of whooping cough in newborn infants. Boostrix is the first vaccine in the US indicated for the protection of newborns under two months of age from pertussis.

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The Pharma Data

JUNE 28, 2021

Food and Drug Administration (FDA) has informed the company that the FDA will not meet the Prescription Drug User Fee Act (PDUFA) action dates for the supplemental New Drug Applications (sNDAs) for RINVOQ ® (upadacitinib) for the treatment of adults with active psoriatic arthritis and adults with active ankylosing spondylitis.

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The Pharma Data

JUNE 30, 2021

” A total of 746 patients who completed the 8-week upadacitinib induction treatment with clinical response and received at least one dose of the study drug in the maintenance period were included in the safety analysis. You are encouraged to report negative side effects of prescription drugs to the FDA. events and 7.9

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The Pharma Data

JUNE 18, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Serious infections have happened in some people taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body.

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