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. What is the Animal Drug Regulatory Process?

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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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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.

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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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Advarra

JULY 26, 2022

However, it’s not legal federally and is considered a Schedule I drug by the U.S. Drug Enforcement Administration (DEA), meaning it has no accepted medical use and a high potential for abuse. With the exception of one highly purified form of CBD (Epidiolex), no other CBD products are currently FDA approved.

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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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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

NOVEMBER 10, 2023

The US Food and Drug Administration (FDA) has approved Takeda Pharmaceuticals’ Adzynma, the first recombinant protein product for prophylactic (preventive) or on‑demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), an ultra-rare blood clotting disorder.

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pharmaphorum

NOVEMBER 24, 2020

The FDA has approved Alnylam’s gene silencing drug Oxlumo, the first treatment for primary hyperoxaluria type 1 (PH1), an ultra-rare and life-threatening genetic disorder. Alnylam is hoping that revenue will stream from its new products and payments from Novartis, which owns the rights to cholesterol lowering drug inclisiran.

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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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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. Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target.

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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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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 latter got an accelerated okay for newly-diagnosed patients in combination with chemotherapy in 2018.

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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

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. It has however been contraindicated in people taking opioids.

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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

SEPTEMBER 16, 2021

The US agency has given the go-ahead to Cour Pharmaceuticals to evaluate the safety and efficacy of CNP-201, a drug intended to treat peanut allergies.

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XTalks

JANUARY 26, 2023

The US Food and Drug Administration (FDA) recently granted approval for the Bruton tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) based on the results from two Phase III clinical trials. Brukinsa is now approved to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

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XTalks

AUGUST 19, 2021

The US Food and Drug Administration (FDA) has approved a new indication for Jazz Pharmaceuticals’ (Nasdaq: JAZZ ) Xywav for idiopathic hypersomnia (IH) in adults. With the FDA green light, Xywav has become the first drug approved for IH. This, despite the drug having strict regulations and safety concerns.

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XTalks

JULY 27, 2023

Last week, the US Food and Drug Administration (FDA) stood by its decision, denying a petition asking it to reevaluate the use of eight ortho-phthalates in food-contacting packaging materials. Among the plethora of phthalates available on the market, ortho-phthalates are the most prevalent.

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pharmaphorum

MARCH 9, 2022

US House Energy & Commerce Committee Chair Frank Pallone (D-NJ) has introduced a new bill to enhance the Food and Drug Administration’s (FDA) authority to ensure products that receive accelerated approval are providing a clinical benefit to patients. Covis Pharma’s Makena, has been a notable example of this.

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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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BioPharma Reporter

FEBRUARY 6, 2024

In late 2023, Vertex Pharmaceuticals and CRISPR Therapeutics made history by gaining the first FDA approval for a CRISPR-based drug, exagamglogene autotemcel (Casgevy) for the treatment of sickle cell disease with vaso-occlusive crisis.

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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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XTalks

FEBRUARY 8, 2024

Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries. The top 15 diabetes drugs in 2023, according to 2022 sales data, reflect the current state of diabetes management and hint at the evolving needs and trends within this critical area of healthcare.

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The Pharma Data

NOVEMBER 21, 2021

Food and Drug Administration approved Voxzogo (vosoritide) injection to improve growth in children five years of age and older with achondroplasia and open epiphyses (growth plates), meaning these children still have the potential to grow. Today, the U.S. Achondroplasia is the most common form of dwarfism. Source link: [link].

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pharmaphorum

FEBRUARY 28, 2022

Amryt Pharma has been handed a major blow by the FDA, after the US regulator rejected its marketing application for Oleogel-S10, its drug for rare and debilitating skin disease epidermolysis bullosa (EB). The post FDA turns down Amryt’s epidermolysis bullosa drug appeared first on.

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pharmaphorum

JULY 20, 2021

The FDA has taken a longer than usual look at Ardelyx’ regulatory submission for tenapanor, a drug for high blood phosphate levels associated with chronic kidney disease (CKD), and found it wanting – sending the biotech’s shares into a tailspin. Ardelyx was gunning for approval in dialysis patients. “Despite….advantageous

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FDA Law Blog

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. Deb along with fellow panelists Kyle Y.

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Outsourcing Pharma

JUNE 7, 2021

The pharmacy company's Wegovy (semaglutide) is the first therapy designated for chronic weight management that the agency has granted approval since 2014.

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XTalks

SEPTEMBER 28, 2023

In most cases, commercials are regulated to ensure they provide accurate information, include the benefits and risks of the drugs and encourage viewers to talk to their healthcare providers about the medication. The report included a roundup of the top ten TV ad debuts this year, with pharma drugs clinching the top three spots.

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pharmaphorum

AUGUST 13, 2020

Exon-skipping drugs are used to patch the mutations and allow the gene to produce partially functional dystrophin. Viltepso can be used to treat around 8% of DMD patients and previously approved DMD drugs has not been shown to change the course of the disease.

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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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Pharmaceutical Technology

OCTOBER 31, 2022

The US Food and Drug Administration (FDA) has accepted Outlook Therapeutics’ Biologics License Application (BLA) filing for ONS-5010 / LYTENAVA (bevacizumab-vikg) to treat wet age-related macular degeneration (wet AMD). The regulator has set 29 August 2023 as a Prescription Drug User Fee Act (PDUFA) goal date.

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Pharmaceutical Technology

NOVEMBER 30, 2022

Crossing the approval hurdle for a new drug is a big milestone for pharmaceutical companies. However, efficiently manufacturing the drug represents another barrier to cross before realizing the full revenue potential then successfully. The EMA had provided a positive opinion for this marketing authorization back in July.

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