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.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Drugs 52

XTalks

OCTOBER 18, 2022

Global medical device company Nevro Corp has received US Food and Drug Administration (FDA) approval for the Senza HFX iQ spinal cord stimulation (SCS) system for the treatment of long-term or chronic pain.

FDA Approval 97

FDA Approval Clinical Trials Clinical Trials Life Science 97

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.

FDA Approval 59

FDA Approval Bacteria Clinical Trials Clinical Trials 59

XTalks

DECEMBER 7, 2021

The approval is the first for Massachusetts-based VBI Vaccines, a biopharmaceutical company focused on leveraging immunology “in the pursuit of powerful prevention and treatment of disease,” according to the company’s mission statement. And in another first, VBI’s shot is the only approved three-antigen HBV vaccine for adults in the US.

FDA Approval 100

FDA Approval Vaccination Vaccine Drugs 100

XTalks

JANUARY 18, 2023

Ayesha also talked about the FDA approval of AstraZeneca’s asthma inhaler Airsupra, the first-in-class drug that contains both a beta agonist and corticosteroid. The inhaler is approved as a rescue medication for adults with asthma to help treat bronchoconstriction and asthma attacks.

FDA Approval 52

FDA Approval Life Science Drugs Scientist 52

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.

FDA Approval 105

FDA Approval Trials Antibody Drugs 105

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. Kimmtrak is a bispecific protein that contains a soluble T cell receptor fused to an anti-CD3 immune-effector function. Uveal melanoma is a rare and aggressive type of melanoma of the eye.

FDA Approval 98

FDA Approval Protein Medicine Drugs 98

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.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52

Pharmacy Checkers

NOVEMBER 12, 2020

The new federal rule on drug importation from Canada , drafted pursuant to Section 804 of the FDCA, does not allow for the importation of foreign versions of FDA-approved drugs. It only allows for the importation of FDA-approved drugs. Kesselheim called “ Reputation and Authority FDA and the Fight over U.S.

FDA Approval 62

FDA Approval Drugs Filler Manufacturing 62

The Pharma Data

OCTOBER 10, 2022

US FDA approves BOOSTRIX for immunisation during gestation for the forestallment of whooping cough in invigorated babies. The tip caps of the prefilled hypes for BOOSTRIX contain natural rubber latex, which may beget antipathetic responses.

FDA Approval 75

FDA Approval Vaccination Vaccine Containment 75

Pharmaceutical Technology

APRIL 28, 2023

It has also been approved by the FDA for otitis media prevention in infants and children aged between six weeks and five years caused by the original seven serotypes contained in PREVNAR. The latest approval is based on data obtained from the Phase II and Phase III trials of PREVNAR 20 for paediatric indication.

Vaccination 147

Vaccination Vaccine FDA Approval Trials 147

pharmaphorum

AUGUST 6, 2020

There were doubts about whether Blenrep could be approved in the US after a FDA review noted problems with ocular safety associated with the drug ahead of a meeting of the regulator’s expert advisers last month. The post FDA approves GSK’s Blenrep for advanced multiple myeloma appeared first on.

FDA Approval 87

FDA Approval Antibody Drugs Protein 87

pharmaphorum

DECEMBER 4, 2020

That means it targets both the primary mutation in this form of NSCLC and the resistance mechanism at the same time, according to J&J, which has previously said it plans to expand use of the drug to “all EGFR-containing tumours”, challenging Tagrisso and other TKIs like AZ’s older Iressa (gefitinib) and Roche’s Tarceva (erlotinib).

FDA Approval 93

FDA Approval Antibody Drugs Licensing 93

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. COMIRNATY was previously FDA approved for individuals 16 years and older in August 2021. Fri, 07/08/2022 - 11:48.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

The Pharma Data

SEPTEMBER 30, 2022

Relyvrio contains taurursodiol, a corrosiveness acid, which may beget worsening diarrhea in cases with diseases that intrude with corrosiveness acid rotation. The cases treated with Relyvrio endured a slower rate of decline on a clinical assessment of diurnal functioning compared to those entering a placebo.

FDA Approval 96

FDA Approval Medicine Drugs Cosmetics 96

The Pharma Data

AUGUST 31, 2021

In addition, as part of the label update, this indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy.

FDA Approval 52

FDA Approval Containment Clinical Research Clinical Development 52

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 95

FDA Approval Clinical Trials Clinical Trials Drugs 95

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.

FDA Approval 98

FDA Approval Medicine Vaccination Vaccine 98

XTalks

OCTOBER 14, 2022

The study was conducted using a non-US formulation of Boostrix, but the FDA considers the safety data and results relevant because the components are the same in both Boostrix formulations, the non-US option only contains more aluminum per dose.

FDA Approval 98

FDA Approval Vaccination Vaccine Protein 98

The Pharma Data

JULY 8, 2021

1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy.

FDA Approval 52

FDA Approval Trials Genome Genomics 52

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.

FDA Approval 52

FDA Approval Vaccination Vaccine Clinical Trials 52

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. Product logo and product image courtesy of Bristol Myers Squibb. Lymphoma is one of the most aggressive types of cancer. The patients were randomized and grouped into Arm A or Arm B.

FDA Approval 52

FDA Approval Gene Therapy Antibody Gene 52

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.

FDA Approval 40

FDA Approval Clinical Trials Clinical Trials Trials 40

XTalks

JUNE 5, 2023

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). Ozempic was approved for the management of type 2 diabetes mellitus in adults in addition to a reduced-calorie diet and exercise. The approved drugs contain the base form of semaglutide.

FDA Approval 52

FDA Approval Drugs Pharmacy Insulin 52

Pharmaceutical Technology

MAY 5, 2023

In an alert issued last week , the FDA said apetamin is being promoted over social media as a weight-gain solution and highlighted that young adults are reporting cardiac and nervous system disorders, and liver injury after taking the drug.

FDA Approval 130

FDA Approval Drugs Pharmacy Containment 130

STAT News

DECEMBER 12, 2022

The new medicine, a pill called Krazati, was cleared to treat patients with advanced non-small cell lung cancer containing a specific type of KRAS alteration called G12C. The mutation is found in approximately 13% of lung tumors. Continue to STAT+ to read the full story…

FDA Approval 98

FDA Approval Drugs Clinical Trials Clinical Trials 98

The Pharma Data

NOVEMBER 29, 2021

The use of folate, folic acid, or folate-containing supplements should be avoided within 48 hours before administration of Cytalux. The FDA previously granted Cytalux orphan-drug , priority and fast track designations. The FDA granted the approval to On Target Laboratories, LLC. The FDA, an agency within the U.S.

FDA Approval 52

FDA Approval Drugs Protein Cosmetics 52

XTalks

JANUARY 17, 2023

The US Food and Drug Administration (FDA) granted approval to AstraZeneca’s Airsupra (albuterol/budesonide), formerly known as PT027, for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of asthma attacks in individuals aged 18 years and older who have asthma.

FDA Approval 94

FDA Approval Drugs Allergies Containment 94

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. Related Articles: Danyelza (naxitamab-gqgk) FDA Approval History. NEW YORK, Nov. Source link.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Antibody 52

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 Clinical Trials Clinical Trials 98

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.

FDA Approval 116

FDA Approval Drugs Clinical Trials Clinical Trials 116

The Pharma Data

OCTOBER 21, 2022

About SELECT- AXIS 2 trial program4 SELECT- AXIS 2 was conducted as a master study protocol that contains two standalone studies with randomization, data collection, analysis and reporting conducted singly. For further details, please visitAbbVie.com/myAbbVieAssist.

FDA Approval 75

FDA Approval Clinical Trials Clinical Trials Trials 75

Pharmaceutical Technology

MARCH 2, 2023

Keytruda is also indicated as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy, as well as adults who are not eligible for any platinum-containing chemotherapy.

FDA Approval 100

FDA Approval Drugs Genome Genomics 100

Pharmaceutical Technology

MARCH 2, 2023

Keytruda is also indicated as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy, as well as adults who are not eligible for any platinum-containing chemotherapy.

FDA Approval 100

FDA Approval Drugs Genome Genomics 100

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. It is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration supplied in a single patient use fliptop vial.

Containment 98

Containment Vaccination Vaccine FDA Approval 98

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. The long-acting injection can help relieve HIV patients from having to take a daily cocktail of pills.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials RNA 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.

FDA Approval 52

FDA Approval Drugs Dermatology Clinical Trials 52