STAT News

DECEMBER 12, 2022

However, hopes the drug might reach a large swath of patients — and grow into a commercial blockbuster for its maker Mirati Therapeutics — have dimmed in the wake of underwhelming clinical trial results. The mutation is found in approximately 13% of lung tumors.

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Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

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XTalks

APRIL 23, 2021

The therapy is indicated for endometrial cancer that has progressed during, or following, prior treatment with a platinum-based chemotherapy, and in women with dMMR tumors as determined by an FDA-approved test. The immunotherapy has also become the first targeted therapy for the dMMR positive subset of endometrial cancers.

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FDA Approval Trials Antibody DNA 105

XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. Regulatory Approvals for CTC-Based Assays in Oncology.

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Clinical Trials Clinical Trials Trials FDA Approval 98

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. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial.

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FDA Approval Vaccination Vaccine Clinical Trials 102

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). Jazz Pharmaceuticals announced the U.S.

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FDA Approval Medicine Vaccination Vaccine 98

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. Fabre Kramer Pharmaceuticals, Inc.,

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FDA Approval Clinical Trials Clinical Trials Trials 105

The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials.

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Clinical Trials Clinical Trials FDA Approval Trials 52

XTalks

DECEMBER 2, 2022

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). Rebyota is not indicated for the first occurrence of C.

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FDA Approval Bacteria Clinical Trials Clinical Trials 59

XTalks

AUGUST 18, 2023

Izervay is the only approved treatment for geographic atrophy that has demonstrated a significant decrease in the rate of geographic atrophy progression at the 12-month primary endpoint, based on results from two rigorous Phase III clinical trials. Izervay contains avacincaptad pegol sodium, an effective complement C5 inhibitor.

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FDA Approval Drugs Clinical Trials Clinical Trials 52

XTalks

APRIL 6, 2021

It was approved under the Premarket Approval (PMA) pathway, which is the most stringent type of device marketing application required by the FDA.

FDA Approval 98

FDA Approval Radiology Containment Clinical Trials 98

pharmaphorum

SEPTEMBER 21, 2020

It’s the same indication targeted by Janssen with another medicine that drew inspiration from an illegal recreational drug – Spravato is an FDA-approved nasal spray containing esketamine, an isomer of ketamine.

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Medicine FDA Approval Clinical Trials Clinical Trials 134

XTalks

NOVEMBER 10, 2023

Adzynma is a an ERT containing purified recombinant form of the ADAMTS13 enzyme administered to boost levels of the deficient enzyme in patients with cTTP. Today, we are proud to further support the rare disease community by delivering Adzynma as the first FDA-approved therapeutic option for people with cTTP.”

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FDA Approval Gene Therapy Gene Clinical Trials 59

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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FDA Approval Drugs Antibody Trials 98

XTalks

JUNE 6, 2023

Posluma is now the first and only radiohybrid PSMA-targeted PET imaging agent to receive FDA approval. Posluma contains a radioactive imaging agent, fluorine-18 ( 18 F), that is designed to specifically bind to the PSMA over-expressed on prostate cancer cells. Gauden, CEO of Blue Earth Diagnostics, in the company’s news release.

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FDA Approval Clinical Trials Clinical Trials Marketing 96

XTalks

DECEMBER 22, 2023

Glaukos Corporation, a leader in ophthalmic medical technology and pharmaceuticals with a focus on novel treatments for glaucoma, corneal disorders and retinal diseases, has secured US Food and Drug Administration (FDA) approval for iDose TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog intended for one-time use per eye.

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XTalks

MARCH 10, 2023

This US Food and Drug Administration (FDA)-approved drug was also awarded a rare pediatric disease priority review voucher. Omaveloxolone Clinical Trials Skyclarys is an oral medication that contains omaveloxolone, an activator of the nuclear factor-erythroid 2 related factor 2 (Nrf2) pathway.

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XTalks

NOVEMBER 5, 2024

per unit, included 958,903 units, each containing one ordinary share and three warrants to purchase additional shares at an exercise price of $4.38 is advancing novel nasal spray-based hydrogels with two innovative platforms: Capture and Contain (C&C) and Trap and Target (T&T). Polyrizon Ltd., million in gross proceeds.

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XTalks

NOVEMBER 22, 2021

Virtual reality pain therapy company AppliedVR bagged de novo clearance from the US Food and Drug Administration (FDA) this week for its virtual reality EaseVRx system indicated as an adjunct treatment for chronic lower back pain for patients 18 years of age and older. Clinical Evidence for Virtual Reality Pain Treatment.

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FDA Approval Clinical Trials Clinical Trials Trials 52

Pharmaceutical Technology

OCTOBER 26, 2022

Early gene therapy methods were proposed in the 1970s, and the first approved gene therapy clinical research in the US began in 1990. The first FDA-approved gene therapies (Luxturna and Kymriah) entered the market in 2017. The future of cell and gene therapies. Collaboration and integrated manufacturing.

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pharmaphorum

DECEMBER 14, 2022

Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. It contains 109% of the American Heart Association’s ideal daily allowance for sodium intake.

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Camargo

NOVEMBER 11, 2020

announced a collaboration to develop a companion diagnostic for Vitrakvi® (larotrectinib) NTRK (neurotrophic tropomyosin receptor kinase) inhibitor, approved in the U.S. In October, less than 18 months later, the FDA approved the companion test, which will allow physicians to better identify target eligible patients.

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Camargo

JANUARY 14, 2021

If you are developing a combination product, Camargo can help you design the fastest, most efficient path to approval. Approval of the Month: FDA Clears Orladeyo from Biocryst Pharmaceuticals. Orladeyo is a new molecular entity (NME) with orphan drug designation that is not approved elsewhere in the world.

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XTalks

MAY 26, 2023

Brixadi is specifically indicated for patients who have already started treatment with a single dose of a transmucosal buprenorphine product (that enters across a mucous membrane) or are currently receiving treatment with a transmucosal buprenorphine-containing product. It is offered in two regimens: weekly and monthly.

FDA Approval 97

FDA Approval Containment Clinical Trials Clinical Trials 97

XTalks

JANUARY 25, 2021

GlaxoSmithKline’s (GSK) ViiV Healthcare — which focuses on HIV treatments and prevention — has received approval from the US Food and Drug Administration (FDA) for its highly anticipated injectable HIV treatment. Cabenuva and Vocabria were granted Fast Track and Priority Review designation by the FDA.

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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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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. It’s very exciting to see this treatment go from being an experimental therapy used at my daughter’s bedside to now being FDA approved. The FDA granted approval under the accelerated approval regulation. NEW YORK, Nov.

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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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The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S. in 1-15 year olds and 98.7-100%

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XTalks

MAY 24, 2022

More than two dozen antiretroviral drugs are approved by the US Food and Drug Administration (FDA) to treat HIV infection. The FDA has allowed clinical trials assessing the injectable lenacapavir, an investigational long-acting HIV-1 capsid inhibitor in development by Gilead Inc., Clinical Trials of Lenacapavir.

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Bioengineer

JULY 20, 2021

FDA approval based on positive results of international, multi-center ProDERM study. The prospective, double-blind, placebo-controlled Phase III clinical trial enrolled 95 patients at 36 sites globally, including 17 sites in the U.S., Octagam® 10% does not contain sucrose. Credit: Octapharma. PARAMUS, N.J.

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FDA Approval Clinical Trials Clinical Trials Trials 40

XTalks

MAY 15, 2023

Chiesi Global Rare Diseases in collaboration with Protalix BioTherapeutics announced the US Food and Drug Administration (FDA) approval of their new medication Elfabrio (pegunigalsidase alfa-iwxj) for the treatment of Fabry disease. The administration of Elfabrio is performed by a healthcare professional.

FDA Approval 98

FDA Approval Gene Genetics Clinical Trials 98

The Pharma Data

DECEMBER 16, 2020

We will now rapidly move to initiate our Phase 2 trial of Berubicin for adults with GBM and expect to begin enrolling patients in the first quarter of next year,” commented John Climaco , CEO of CNS Pharmaceuticals. and 2 trials planned by our sublicensee WPD in Poland. . .

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FDA Approval Drugs Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. The FDA approval of Klisyri is a significant milestone for Athenex.

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The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. The increase in survival observed with Zokinvy was derived from two open-label clinical trials (N=62) conducted at Boston Children’s Hospital. PALO ALTO, Calif., Outside the U.S.,

FDA Approval 52

FDA Approval Genetics Clinical Trials Clinical Trials 52

pharmaphorum

OCTOBER 2, 2020

It’s the same indication targeted by Janssen with another medicine that drew inspiration from an illegal recreational drug – Spravato is an FDA-approved nasal spray containing esketamine, an isomer of ketamine.

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Medicine Life Science FDA Approval Development 122

XTalks

JUNE 29, 2022

The new FDA approval gives Breyanzi (lisocabtagene maraleucel) the broadest patient eligibility of any CAR T-cell therapy in relapsed or refractory LBCL. Outcomes of Clinical Trials for Breyanzi. Product logo and product image courtesy of Bristol Myers Squibb. Lymphoma is one of the most aggressive types of cancer.

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FDA Approval Gene Therapy Antibody Gene 52