BioSpace

OCTOBER 12, 2023

The regulator's approval of oral, once-daily etrasimod, to be marketed as Velsipity, was based on favorable Phase III safety and efficacy data showing significant clinical remission of ulcerative colitis.

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BioPharma Reporter

MARCH 21, 2024

Since Roche's Zelboraf (vemurafenib)gained FDA approval in 2011, significant strides have been made in BRAF-targeted cancer therapies, underscoring the significance of combating BRAF mutations in melanoma.

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pharmaphorum

JANUARY 26, 2022

Immunocore has secured a piece of biotech industry history, becoming the first company to get an FDA approval for a cancer therapeutic based on T cell receptor (TCR) technology. The post Immunocore claims first-ever FDA approval for TCR cancer therapy appeared first on.

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Drug Discovery World

AUGUST 21, 2023

Ipsen’s Sohonos (palovarotene) has become the first drug approved for patients with fibrodysplasia ossificans progressiva (FOP) in the US, following the granting of a marketing authorisation by the Food and Drug Administration (FDA). The EU’s regulator chose not to recommend the drug in January 2023.

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BioPharma Reporter

JULY 29, 2021

Yesterday saw the US Food and Drug Administration (FDA) approve the first interchangeable biosimilar drug.

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pharmaphorum

SEPTEMBER 16, 2021

Takeda has had a run of bad luck with its Wave1 pipeline of new drug candidates of late, but can now celebrate a vestry after getting FDA approval for first-in-class lung cancer therapy Exkivity. The post Takeda gets a win for its Wave1 pipeline, as Exkivity nabs FDA approval appeared first on.

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Advarra

JULY 26, 2022

Even though CBD and cannabis usage has grown, and marketing claims have proliferated regarding potential therapeutic applications, there is still little research on their effects on the human body. Cannabis and cannabis-derived compounds are treated the same as other FDA-regulated products and subject to the same authorities and requirements.

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XTalks

NOVEMBER 10, 2023

cTTP is a very rare, inherited and life-threatening blood clotting disorder caused by a disease-causing mutation in the ADAMTS13 (A disintegrin and metalloproteinase with thrombospondin motifs 13) gene, which encodes the ADAMTS13 enzyme that regulates blood clotting by cleaving the von Willebrand factor (VWF) protease.

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pharmaphorum

JANUARY 16, 2023

China’s Luye Pharma has claimed its first FDA approval, getting a green light for Rykindo, an injectable formulation of the antipsychotic risperidone given every two weeks. ” The post Luye claims its first FDA approval, for bi-weekly schizophrenia drug appeared first on.

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Pharmaceutical Technology

JUNE 21, 2023

Ketarx will be marketed under the FDA-approved label of ketamine and in dosages that include 10mg/ml, 50mg/ml and 100mg/ml, with the option to boost the concentration and ready-to-administer applications. Ketamine is currently on the FDA’s drug shortage list.

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XTalks

DECEMBER 2, 2022

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).

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STAT News

JULY 29, 2022

Sarepta Therapeutics said Friday that it intends seek regulators’ approval for its gene therapy to treat Duchenne muscular dystrophy earlier than expected — a risky move but one that could help the company reach the market much faster. In early Friday trading, Sarepta shares rose 12% to $96.50.

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XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. BTK plays an important role in the immune system by regulating B cell receptor signaling through its effects on the development and maturation of B cells.

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Outsourcing Pharma

JANUARY 25, 2021

The agency has given the thumbs up to ViiVâs once-a-month Cabenuva, the first FDA-approved injectable, complete regimen for adults diagnosed with HIV.

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XTalks

JANUARY 25, 2023

Massachusetts-based TheracosBio has received US Food and Drug Administration (FDA) approval for diabetes med Brenzavvy (bexagliflozin) to help improve glycemic control in adults with type 2 diabetes. It is the first FDA-approved SGLT2 inhibitor for any animal species.

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BioPharma Reporter

APRIL 23, 2024

Food and Drug Administration (FDA) has approved a subcutaneous (SC) version of Entyvio, its treatment for adults with moderate to severe Crohnâs disease (CD). Takeda has announced that the U.S.

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pharmaphorum

AUGUST 4, 2021

Bristol-Myers Squibb’s HDAC inhibitor Istodax has been on the US market for a decade as a treatment for peripheral T-cell lymphoma (PTCL), but will now be withdrawn from sale after a failed phase 3 trial. The post Failed trial nixes another FDA approval, this time for BMS’ Istodax appeared first on.

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FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Most OTC drugs, particularly drugs that have been around for a while, are primarily marketed pursuant to OTC monographs.

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XTalks

JULY 27, 2023

Among the plethora of phthalates available on the market, ortho-phthalates are the most prevalent. The FDA has granted approval to 30 ortho-phthalates for employment as material in food packaging and processing equipment in contact with food.

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pharmaphorum

JUNE 3, 2021

The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market. The post After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi appeared first on.

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pharmaphorum

MAY 5, 2022

Three years after it was formed as a spinout of Japanese drugmaker Takeda, Phathom Pharmaceuticals has racked up its first FDA approvals, and claimed a sizeable $260 million in new financing to help with the rollout. The post Takeda spinout Phathom claims its first FDA approvals appeared first on.

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pharmaphorum

NOVEMBER 24, 2020

Oxlumo (lumasiran) was also approved in the European Union last week, making it the third from Alnylam’s pipeline of RNA interference therapeutics to make it to market. The Swiss pharma’s bet looks to have paid off as inclisiran is likely to be approved in Europe in the coming weeks after backing from CHMP regulators last month.

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pharmaphorum

MARCH 9, 2022

Under the proposed Accelerated Approval Integrity Act, the FDA would be granted power to expedite the withdrawal of an accelerated approval status if the required post market studies are not completed within five years. The post New bill moves to tighten accelerated approval regulation in US appeared first on.

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Pharma in Brief

JANUARY 7, 2024

On January 5, 2024, the US Food and Drug Administration ( FDA ) approved Florida’s proposal to import prescription drugs from Canada. This is the first approval of a Section 804 Importation Program ( SIP ) by the FDA. The export regulations were later incorporated into the Food and Drug Regulations ( FDR ) in 2021.

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BioPharma Reporter

MARCH 19, 2024

Food and Drug Administration has cleared AGC Biologicsâ Milan site to begin manufacturing of Orchard Therapeuticsâ Lenmeldy (atidarsagene autotemcel), a gene therapy for early-onset metachromatic leukodystrophy (MLD).

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pharmaphorum

FEBRUARY 23, 2022

Ben Hargreaves takes a look at why uptake began slowly in both the EU and the US, and then began to accelerate to see biosimilars take a large portion of market share away from originator products. One way in which the pharmaceutical industry and regulators have reacted is by developing or facilitating the development of biosimilars.

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XTalks

JUNE 12, 2023

Recent FDA Approvals of Cell Therapy Manufacturing Facilities in the US Successful commercialization of novel cell therapy requires exemplary performance at all stages, including upstream and downstream processing, process development, testing and manufacturing services. billion in 2021, is projected to reach an impressive $60.67

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BioPharma Reporter

JUNE 7, 2021

The US Food and Drug Administration (FDA) has approved Biogenâs Aduhelm (aducanumab) for the treatment of Alzheimerâs: making it the first new treatment approved for the disease since 2003.

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FDA Law Blog

JULY 8, 2021

Javitt — For many years, one of the most controversial topics in device regulation has been the dual-track oversight of in vitro diagnostics (IVDs) and laboratory developed tests (LDTs). At various points and in various ways, FDA has sought – mostly unsuccessfully – to regulate LDTs (see here ).

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Outsourcing Pharma

MARCH 22, 2022

The agency has approved Lynparza for use in the US as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. This indication is approved under accelerated approval regulation based on overall response rate and duration of response. The FDA granted approval under the accelerated approval regulation. NEW YORK, Nov.

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XTalks

AUGUST 19, 2021

With the FDA green light, Xywav has become the first drug approved for IH. This, despite the drug having strict regulations and safety concerns. GHB has now become a strictly regulated medication for treating narcolepsy, which is also associated with excessive daytime sleepiness. In 2020, it garnered $1.74

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Outsourcing Pharma

FEBRUARY 7, 2022

The HIV-focused pharma company announced the agency has approved Cabenuva for administration as few as six times a year for adults living with the virus.

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The Pharma Data

NOVEMBER 21, 2021

People with achondroplasia have a genetic mutation that causes a certain growth regulation gene called fibroblast growth factor receptor 3 to be overly active, which prevents normal bone growth. A condition of this accelerated approval is a post-marketing study that will assess final adult height. Source link: [link].

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Outsourcing Pharma

NOVEMBER 22, 2021

The US agency has granted approval to Voxzogo, an injectable drug designed to aid growth in children with achondroplasia, the most common form of dwarfism.

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Outsourcing Pharma

MARCH 31, 2022

A renowned university researcher explains the path that laid the foundation and what the novel diagnostic and treatment means for prostate cancer patients.

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BioPharma Reporter

FEBRUARY 27, 2023

The US Food and Drug Administration (FDA) has approved Sanofi and Sobiâs Altuviio (efanesoctocog alfa): a first-in-class, high-sustained factor VIII replacement therapy.

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