Pharmaceutical Technology

DECEMBER 1, 2022

Ferring Pharmaceuticals president Per Falk said: “This is the first FDA approval of a live biotherapeutic and the culmination of decades of research and clinical development. The post US FDA approves Ferring’s Rebyota for Clostridioides difficile infection appeared first on Pharmaceutical Technology.

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Pharmaceutical Technology

MARCH 10, 2023

The company stated that the regulatory approval expands its migraine portfolio, which includes oral therapy for acute and preventive treatment. Zavzpret underscores Pfizer’s commitment to delivering an additional treatment option to help people with migraine gain relief and get back to their daily lives.

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Pharmaceutical Technology

MAY 24, 2023

Innoviva has snagged a win for its bacterial pneumonia drug Xacduro (durlobactam sodium + sulbactam) with a US Food and Drug Administration FDA approval for use in patients of ages 18 or older. The FDA approval stemmed from results from Entasis’ Phase III Attack trial (NCT03894046).

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Pharmaceutical Technology

APRIL 27, 2023

Seres president and CEO Eric Shaff said: “Seres has led the development of microbiome therapeutics, and today’s FDA approval of Vowst as the first orally administered microbiota-based therapeutic for the prevention of recurrent C difficile infection marks a tremendous milestone for the patient community, and for Seres.

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Pharmaceutical Technology

FEBRUARY 20, 2023

The post US FDA approves Apellis’ geographic atrophy therapy Syfovre appeared first on Pharmaceutical Technology. Vitreous floaters, ocular discomfort, conjunctival hemorrhage, and neovascular AMD were the most common adverse reactions observed in patients receiving Syfovre.

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FDA Approval Drugs Trials 246

Pharmaceutical Technology

MAY 23, 2023

Indivior CEO Mark Crossley said: “Opvee’s FDA approval represents a significant achievement in the development of new treatment options to address today’s era of opioid overdoses that are driven by powerful synthetic opioids such as fentanyl.

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Pharmaceutical Technology

MAY 22, 2023

The FDA approval of Epkinly represents a new treatment mechanism of action for third-line DLBCL patients. “As AbbVie research and development senior vice-president and chief scientific officer Thomas Hudson stated: “DLBCL is an aggressive cancer type that can rapidly progress and resist treatment.

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Pharmaceutical Technology

FEBRUARY 2, 2023

The post US FDA approves GSK’s Jesduvroq to treat anaemia of CKD appeared first on Pharmaceutical Technology. Last December, GSK and Wave Life Sciences entered a strategic partnership to drive the discovery and development of oligonucleotide therapies for new genetic targets.

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FDA Approval Genetics Life Science Trials 264

Pharmaceutical Technology

JANUARY 9, 2023

The post US FDA approves Eisai-Biogen’s antibody for Alzheimer’s appeared first on Pharmaceutical Technology. Leqembi met the primary endpoint and all the critical secondary endpoints in the Clarity AD trial. The Amyloid-Related Imaging Abnormalities (ARIA) incidence profile of Leqembi was within expectations.

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Pharmaceutical Technology

MAY 25, 2023

Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval. It will be offered to patients in prefilled syringe and autoinjector administration options.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2023

The US Food and Drug Administration (FDA) on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in mild and early stages of Alzheimer’s disease.

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Pharmaceutical Technology

AUGUST 12, 2022

The latest development comes after Enhertu received FDA approval for treating unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. The post US FDA approves Daiichi Sankyo-AstraZeneca’s Enhertu for lung cancer appeared first on Pharmaceutical Technology.

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Pharmaceutical Technology

MARCH 13, 2023

Daybue is claimed to be the first and only drug to receive approval to treat Rett syndrome, a complex, rare neurodevelopmental disorder that affects 6,000 to 9,000 patients in the US. Acadia Pharmaceuticals CEO Steve Davis said: “Today marks an important milestone for the Rett community and Acadia.

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Pharmaceutical Technology

MAY 11, 2023

Lundbeck president and CEO Deborah Dunsire stated: “This approval is a testament to our commitment and unwavering support of patients and caregivers to lessen the symptoms of agitation associated with dementia due to Alzheimer’s disease. “We

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Pharmaceutical Technology

NOVEMBER 18, 2022

The post US FDA approves Provention Bio’s Tzield to delay diabetes appeared first on Pharmaceutical Technology. They received a 14-day course of either teplizumab or a placebo. Provention Bio stated that Tzield delayed the median onset of Stage 3 T1D by 25 months, or nearly two years, compared to a placebo in a clinical trial.

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Pharmaceutical Technology

MAY 22, 2023

It is claimed to be both the first re-dosable gene therapy and the first and only FDA-approved treatment for both recessive and dominant types of DEB, a rare and serious genetic disease affecting the skin and mucosal tissues.

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FDA Approval Gene Therapy Genetic Disease Gene 130

The Pharma Data

JUNE 2, 2023

Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. For the U.S. Source link: [link]

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Pharmaceutical Technology

JANUARY 30, 2023

Eli Lilly and Company ’s (Lilly) oncology unit Loxo@Lilly has secured the US Food and Drug Administration (FDA) approval for Jaypirca (pirtobrutinib) to treat relapsed or refractory mantle cell lymphoma (MCL). The post Lilly’s Jaypirca received FDA approval to treat MCL appeared first on Pharmaceutical Technology.

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Pharmaceutical Technology

FEBRUARY 3, 2023

It was initially FDA-approved in December 2021 and is claimed to be the only biologic approved to treat severe asthma with no phenotype or biomarker limitation. The antibody has already been approved for the same indication in Japan, the EU, the US and other countries.

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FDA Approval Clinical Trials Clinical Trials Antibody 147

Bio Pharma Dive

MARCH 23, 2023

Rezzayo is the first new treatment for candidemia and invasive candidiasis to win FDA approval in years.

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FDA Approval Drugs 162

Pharmaceutical Technology

FEBRUARY 13, 2023

Pfizer has received the US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for Cibinqo (abrocitinib) to treat a type of atopic dermatitis (AD). The post Pfizer’s sNDA for Cibinqo receives FDA approval for atopic dermatitis appeared first on Pharmaceutical Technology.

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FDA Approval Clinical Trials Clinical Trials Drugs 147

Pharmaceutical Technology

SEPTEMBER 19, 2022

“For the ALD community, this long-awaited approval represents significant hope and offers families a new option where, for many, there had been none.”. The post FDA approves bluebird bio’s Skysona to treat cerebral adrenoleukodystrophy appeared first on Pharmaceutical Technology. thalassemia.

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FDA Approval Gene Therapy In-Vivo Clinical Trials 246

Pharmaceutical Technology

FEBRUARY 9, 2023

Until now, the only FDA-approved treatment in common use was laser photocoagulation, a complex and lengthy procedure that permanently ablates retina tissue and is stressful not only for infant patients but also for the family navigating a delicate time after preterm birth.

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Bio Pharma Dive

MAY 24, 2023

The drug, called Xacduro, will be made available later this year by Innoviva Specialty Therapeutics, a new company formed from antibiotic developers Entasis and La Jolla.

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FDA Approval Drugs Development 290

Pharmaceutical Technology

JANUARY 16, 2023

The post US FDA approves Luye Pharma’s schizophrenia treatment Rykindo appeared first on Pharmaceutical Technology. According to Luye Pharma, currently, there are approximately 24 million schizophrenia patients, and nearly 40 million bipolar disorder patients were reported globally in 2019.

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Fierce Pharma

MAY 22, 2023

Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis zbecker Mon, 05/22/2023 - 14:43

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FDA Approval 139

Pharmaceutical Technology

FEBRUARY 1, 2023

Ellipses Pharma CEO and founder Dr Rajan Jethwa said: “This FDA approval of EP0042’s Investigational New Drug application allows us to open additional trial sites in the world’s foremost pharmaceutical market. The post US FDA approves Ellipses Pharma’s IND for AML therapy appeared first on Pharmaceutical Technology.

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FDA Approval In-Vivo In-Vitro Clinical Trials 130

Pharmaceutical Technology

JULY 8, 2022

The post Specialised Therapeutics’ breast cancer drug gets Philippines FDA approval appeared first on Pharmaceutical Technology. “From a patient perspective, this is the first time the women in the Philippines are being presented with an opportunity for extended-adjuvant therapy that will reduce the risk of disease recurrence.”.

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FDA Approval Drugs Clinical Trials Clinical Trials 246

Pharmaceutical Technology

SEPTEMBER 30, 2022

These approvals represent crucial milestones for bluebird bio, the gene therapy field, and patients with rare genetic diseases. Prior to bluebird's approvals, there were only two FDA-approved gene therapies for inherited conditions on the market.

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Fierce Pharma

MAY 19, 2023

Bausch + Lomb bags FDA approval for dry eye disease treatment Miebo zbecker Fri, 05/19/2023 - 09:39

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FDA Approval 133

Pharmaceutical Technology

MARCH 27, 2023

It is claimed to be the first and only therapy to receive approval in the US for the treatment of APDS, a rare and progressive primary immunodeficiency.

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FDA Approval Clinical Trials Clinical Trials Medicine 130

Pharmaceutical Technology

FEBRUARY 24, 2023

The post Sanofi’s Altuviiio receives FDA approval to treat haemophilia A appeared first on Pharmaceutical Technology. Findings showed that once-a-week ALTUVIIIO prophylaxis met the primary endpoint and offered significant bleed protection for severe haemophilia A patients with 0.70 means annualised bleeding rate (ABR) and 0.0

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FDA Approval Protein Trials Drugs 147

Pharmaceutical Technology

AUGUST 8, 2022

In July, the companies received Priority Review for their supplemental Biologics License Application (BLA) from the US FDA for Enhertu to treat unresectable or metastatic HER2-low breast cancer. The post AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer appeared first on Pharmaceutical Technology.

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FDA Approval Clinical Trials Clinical Trials Hormones 264

Bio Pharma Dive

MAY 31, 2023

The shot’s clearance comes several weeks after the regulator made GSK’s Arexvy the first vaccine for RSV in the U.S.

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FDA Approval Vaccination Vaccine Regulation 298

Pharmaceutical Technology

APRIL 18, 2023

The regulatory approval for the expanded indication was based on the data obtained from the pivotal Phase III PROGRESS trial, which assessed the efficacy, tolerability and safety of oral Qulipta 60mg once daily (QD) in adult patients with chronic migraine.

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FDA Approval Botox Gene Drugs 130

Bio Pharma Dive

APRIL 25, 2023

Biogen’s drug failed the key study meant to show it can slow the nerve-destroying disease, but the drug’s effect on a protein of interest led the FDA to conditionally clear it for market.

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FDA Approval Medicine Protein Drugs 345

Pharmaceutical Technology

NOVEMBER 9, 2022

With this FDA approval, Libtayo can expand its role as a key treatment option for advanced non-small lung cancer, in addition to serving as a standard-of-care for two advanced non-melanoma skin cancers. “We The post FDA approves Regeneron’s Libtayo and chemotherapy combination for NSCLC appeared first on Pharmaceutical Technology.

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