Pharmaceutical Technology

APRIL 12, 2023

The US Food and Drug Administration (FDA) has approved Takeda ’s supplemental Biologics Licence Application (sBLA) to expand the use of its HyQvia subcutaneous immune globulin (ScIG) for the treatment of primary immunodeficiency (PI) in children aged between two and 16 years. It was previously approved in the US to treat PI in adults.

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Containment 130

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 103

FDA Approval Vaccination Vaccine Marketing 103

XTalks

AUGUST 7, 2023

has received US Food and Drug Administration (FDA) approval for treating molluscum contagiosum in adult and pediatric patients aged two years and older in the US. Formerly known as VP-102, Ycanth is the first cantharidin formulation approved for this purpose. ’s berdazimer gel, containing 10.3

FDA Approval 98

FDA Approval Dermatology Trials Clinical Trials 98

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 DNA 105

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 98

FDA Approval Big Data Life Science Clinical Trials 98

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 Production Vaccination Vaccine 98

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 Sales Antibody Drugs 93

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 Packaging 87

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 Development Containment Licensing 98

World of DTC Marketing

JUNE 6, 2021

The headlines read “FDA approves obesity drug that helped people cut weight 15%” But buyer beware. Wegovy also contains warnings for pancreatitis, gallbladder problems including gallstones, low blood sugar, acute kidney injury, eye retina damage, increased heart rate, and suicidal behavior or thinking.

Drugs 318

Drugs Cosmetics Production FDA Approval 318

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 Sales Drugs Clinical Trials 98

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

JULY 27, 2023

“We evaluated the reconsideration petition and concluded that it does not provide a basis for modifying the FDA’s response to the original citizen petition,” the FDA said in a constituent update.

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Packaging Packaging FDA Approval Production 98

World of DTC Marketing

DECEMBER 13, 2021

Containing cancer and killing those abnormal cells without damaging nearby healthy cells often requires a range of treatments over an extended period of time — lengthy radiation, complicated surgeries, costly chemotherapy, plus other strong medications to supercharge your immunity. What makes cancer such a financial killer? ScienceNews.com.

Drugs 55

Drugs FDA Approval Medicine Containment 55

Pharmaceutical Technology

MAY 24, 2023

Braeburn submitted data from a 24-week Phase III trial (NCT02651584) to support approval. The FDA approval adds a further treatment avenue to tackle the opioid crisis in the US. The year 2023 has seen some landmark regulatory developments to contain the crisis.

FDA Approval 147

FDA Approval Pharmacy Pharma Companies Containment 147

XTalks

AUGUST 18, 2020

Moreover, samples for the SalivaDirect test can be collected in any sterile container, and hence does not require any specific type of swab or collection vessel, making collection quick and easy. Last month, the FDA approved a pooled test for COVID-19 developed by Quest Diagnostics. And now it’s getting approval.

FDA Approval 90

FDA Approval Reagent RNA Genome 90

XTalks

JULY 26, 2024

Compounded semaglutide products, unlike the US Food and Drug Administration (FDA)-approved ones, can vary widely in strength and packaging, making it easy for mistakes to happen. It’s available in three FDA-approved forms: Wegovy and Ozempic, which are injections, and Rybelsus, an oral tablet.

Drug Delivery Systems 92

Drug Delivery Systems FDA Approval Drug Delivery Containment 92

XTalks

JULY 26, 2024

The US Food and Drug Administration (FDA) has given the green light to Femlyv , a combination oral contraceptive containing norethindrone acetate and ethinyl estradiol. Norethindrone acetate and ethinyl estradiol are legacy drugs that have been approved since 1968 in a swallowable tablet form for the prevention of pregnancy.

FDA Approval 52

FDA Approval Hormones Containment Drugs 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.

FDA Approval 59

FDA Approval Bacteria Clinical Trials Clinical Trials 59

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

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.

FDA Approval 52

FDA Approval Allergies Trials Development 52

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

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 Development Trials 52

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.”

FDA Approval 59

FDA Approval Gene Therapy Gene Clinical Trials 59

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.

Life Science 52

Life Science FDA Approval Containment Scientist 52

Pharmaceutical Commerce

JANUARY 19, 2024

Today's approval amends the accelerated approval granted by the FDA in April 2019 to Balversa (erdafitinib) for patients with metastatic urothelial carcinoma with susceptible FGFR2 or FGFR3 alterations following prior treatment with platinum-containing chemotherapy.

FDA Approval 52

FDA Approval Containment 52

XTalks

AUGUST 18, 2023

The FDA approval of Izervay is great news for the retina community and our patients suffering from geographic atrophy,” said Arshad M. Izervay contains avacincaptad pegol sodium, an effective complement C5 inhibitor. How Does Izervay Work?

FDA Approval 52

FDA Approval Drugs Clinical Trials Clinical Trials 52

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

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.

FDA Approval 98

FDA Approval Drugs Antibody Trials 98

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 Engineer Clinical Trials Clinical Trials 52

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 98

FDA Approval Containment Drugs Pharmacy 98

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 97

FDA Approval Containment Allergies Drugs 97

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.,

FDA Approval 105

FDA Approval Clinical Trials Clinical Trials Trials 105

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 Marketing Containment Drugs 116

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 Containment 52

Pharmaceutical Commerce

NOVEMBER 17, 2023

Pembrolizumab (Keytruda) plus fluoropyrimidine- and platinum-containing chemotherapy for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction cancer approved by FDA after being found to lower the risk of metastasis or death.

FDA Approval 52

FDA Approval Containment 52

XTalks

JULY 27, 2022

He showed the bottle label that seemed to indicate that it contains 444 servings of the product, at 60 calories per serving of about a tablespoon — a near mathematical impossibility. FDA-Approved? Shaw was recently fielding questions live on TikTok when someone asked her whether Pink Sauce was FDA-approved.

FDA Approval 98

FDA Approval Packaging Packaging Production 98