Delveinsight

AUGUST 17, 2021

FDA’s Green Flag to Keytruda and Lenvima combination by Merck and Eisai for Advanced renal cell carcinoma (RCC). The FDA approved 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).

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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

JANUARY 12, 2023

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 FDA approval.

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XTalks

MARCH 10, 2023

But with Skyclarys (omaveloxolone), the first and only drug to treat Friedreich’s ataxia in patients aged 16 years and older, Reata Pharmaceuticals has developed a new treatment option to improve neurological function. This US Food and Drug Administration (FDA)-approved drug was also awarded a rare pediatric disease priority review voucher.

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XTalks

AUGUST 18, 2023

After Johnson & Johnson’s US Food and Drug Administration (FDA) approval last week for its second multiple myeloma bispecific, Talvey (talquetamab), Pfizer received an FDA nod for its B-cell maturation antigen (BCMA)-directed therapy Elrexfio (elranatamab) in the same indication.

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Pfizer

JULY 13, 2022

Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), Due To The Potential Presence of Visible Particulate. Propofol is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation. Pfizer Drug Safety.

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The Pharma Data

NOVEMBER 29, 2021

Food and Drug Administration today approved Cytalux (pafolacianine), an imaging drug intended to assist surgeons in identifying ovarian cancer lesions. The drug is designed to improve the ability to locate additional ovarian cancerous tissue that is normally difficult to detect during surgery.

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Drug Discovery World

FEBRUARY 6, 2023

Mesoblast has resubmitted its biologics license application (BLA) to the US Food and Drug Administration (FDA) for approval of remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).

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XTalks

APRIL 23, 2021

GSK’s immunotherapy dostarlimab-gxly (Jemperli) has been granted accelerated approval by the US Food and Drug Administration (FDA) for the treatment of recurrent or advanced mismatch repair-deficient (dMMR) endometrial cancer.

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XTalks

JANUARY 28, 2022

Kimmtrak has also become the first bispecific T cell engager to be FDA-approved for the treatment of a solid tumor. Immunocore received Breakthrough Device Designation for Kimmtrak from the FDA in February 2021 followed by acceptance of its Biologics License Application (BLA) several months later by both US and European regulators.

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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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XTalks

APRIL 29, 2022

Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinical trial, with results showing that people who took the drug lost an average of 50 pounds, or 21 percent, of their body weight compared to placebo. percent and 22.5 percent, respectively, compared to placebo.

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XTalks

SEPTEMBER 28, 2023

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.

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XTalks

OCTOBER 26, 2022

Additionally, the company revealed the latest five-year data from two Phase III studies (Study 1489 and Study 1490) at the 30th International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2022) showing the long-term safety and efficacy profile of Biktarvy in those who switch from a dolutegravir-containing regimen.

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The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.

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Drug Discovery World

AUGUST 3, 2023

In the first part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of medical cannabis in drug discovery. Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance.

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Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Pfizer and BioNTech also filed these data with the European Medicines Agency (EMA) and other regulatory authorities around the world.

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Bioengineer

JULY 20, 2021

FDA approval based on positive results of international, multi-center ProDERM study. “The FDA approval of Octagam® 10% as a safe and effective treatment for dermatomyositis in adults is exciting news for patients who previously relied on unapproved treatments,” said Octapharma USA President Flemming Nielsen.

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XTalks

DECEMBER 26, 2022

has obtained US Food and Drug Administration (FDA) approval of an expanded indication for the use of Cytalux (pafolacianine) for the detection of lung cancer during surgery. On Target Laboratories, Inc. Clinical Trials of Cytalux (pafolacianine). It is an important tool for surgeons to consider for patients.”.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity. BOSTON, Nov. in the first quarter of 2021.

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XTalks

MAY 26, 2023

Braeburn, a US pharmaceutical company specializing in the treatment of opioid use disorder, announced that their drug Brixadi (buprenorphine) has received approval from the US Food and Drug Administration (FDA). Brixadi (weekly) contains 50 mg/mL of buprenorphine base and should be administered every seven days.

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pharmaphorum

SEPTEMBER 21, 2020

Compass Pathways and its potential magic mushroom depression drug went public last week – and now psychedelic therapy firm Mind Medicine is aiming to follow suit by up-listing its shares on the Nasdaq. UK-based Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5

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The Pharma Data

NOVEMBER 2, 2020

Food and Drug Administration, Gover said he believes there is a “clear path” to the submission of a New Drug Application as soon as 2021. If nabiximols is approved, this would mark the second cannabis-based product for GW Pharmaceuticals in the United States. Now is the ideal time to develop nabiximols in the U.S.

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Pharmaceutical Technology

JULY 4, 2022

Russia is an already insular country and its worldview has tended to be self-contained, but this has hardened in the face of recent sanctions and counter-sanctions imposed during the war with Ukraine. On 15 March, Eli Lilly (Indianapolis, Indiana) suspended the export of 'non-essential medicines' to Russia.

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XTalks

OCTOBER 16, 2020

The US Food and Drug Administration (FDA) has approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) as the world’s first treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients, including newborns of mothers who have tested positive for the virus. Targeted Antiviral Treatment.

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pharmaphorum

OCTOBER 31, 2021

The FDA approval is based on the results of GEMINI 1 and GEMINI 2 studies, which showed that Vuity works as quickly as 15 minutes after dosing with a duration of action of up to six hours, improving near and intermediate vision without affecting distance vision. Brimochol is in phase 2 testing.

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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., What Is Demodex Blepharitis?

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XTalks

DECEMBER 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS) Augtyro (repotrectinib), marking a significant milestone for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC).

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. DRUG INTERACTIONS. TARRYTOWN, N.Y., 5 x ULN).

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FDA Law Blog

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. The drug’s history and current pattern of abuse.

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The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Food and Drug Administration (FDA) has approved Zokinvy (lonafarnib) for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies (PL). .

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Pharmaceutical Technology

MARCH 2, 2023

According to GlobalData, Phase III drugs for Bile Duct Cancer (Cholangiocarcinoma) have a 53% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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Pfizer

JULY 19, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Food and Drug Administration (FDA) to support a potential variant-adapted vaccine and continue to submit additional data as advised by the agency.

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XTalks

JUNE 6, 2023

Recently, Blue Earth Diagnostics announced that the US Food and Drug Administration (FDA) has granted approval to its novel, high-affinity radiohybrid prostate-specific membrane antigen (PSMA)-targeted PET imaging agent, Posluma (flotufolastat F 18). Gauden, CEO of Blue Earth Diagnostics, in the company’s news release.

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. The Verquvo label contains a boxed warning that indicates that Verquvo should not be administered to pregnant females because it may cause fetal harm. KENILWORTH, N.J.–(BUSINESS Verquvo (vericiguat) 2.5

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XTalks

AUGUST 15, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced yesterday that the US Food and Drug Administration (FDA) has granted marketing authorization for its combination treatment Akeega for metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 mutations. In April 2016, Janssen Biotech, Inc.

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The Pharma Data

AUGUST 17, 2021

approval of pump use for Lilly’s novel insulin is latest development designed to help people with diabetes manage blood sugar levels. Lyumjev U-200 contains 2 times as much insulin in 1 milliliter as Lyumjev U-100. Humalog U-100 contains 100 units of insulin per milliliter. Before using. Learn more.

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