Pharmaceutical Technology

MARCH 1, 2023

“With the approval of Kevzara for polymyalgia rheumatica, patients now have an FDA-approved treatment to help offer relief from the disabling symptoms of this disease and long-term dependence on steroids.”

FDA Approval 245

FDA Approval Clinical Trials Clinical Trials Trials 245

Pharmaceutical Technology

MARCH 10, 2023

The company stated that the regulatory approval expands its migraine portfolio, which includes oral therapy for acute and preventive treatment. The regulator granted the approval based on two pivotal placebo-controlled, double-blind, randomised trials. The company expects to launch Zavzpret in pharmacies in July.

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FDA Approval Pharmacy Trials Clinical Development 246

Pharmaceutical Technology

JANUARY 9, 2023

Leqembi is indicated to treat mild cognitive impairment or mild dementia stage of the disease in patients whose treatment started in clinical trials. The regulatory approval is based on the data obtained from the Phase II trial. Leqembi met the primary endpoint and all the critical secondary endpoints in the Clarity AD trial.

FDA Approval 246

FDA Approval Antibody Clinical Trials Clinical Trials 246

Bio Pharma Dive

AUGUST 2, 2021

The regulator cleared Saphnelo despite mixed clinical trial data, giving patients another option after the recent OK for a drug aimed at the autoimmune disease's severe side effects.

FDA Approval 343

FDA Approval Clinical Trials Clinical Trials Drugs 343

Pharmaceutical Technology

FEBRUARY 2, 2023

The regulatory approval is based on the data obtained from the ASCEND-D trial, which is evaluating Jesduvroq’s safety and efficacy to treat patients. The ASCEND programme included five Phase III trials that enrolled more than 8,000 patients who received treatment for up to 4.26 dL) for the patients.

FDA Approval 265

FDA Approval Life Science Genetics Trials 265

CTTI (Clinical Trials Transformation Initiative)

MARCH 19, 2025

A new publication from the FDA Oncology Center of Excellence (OCE) and the Clinical Trials Transformation Initiative (CTTI), published in the Clinical Cancer Research journal, provides important insights into how decentralized clinical trial (DCT) elements were used in cancer trials leading to FDA approval during the COVID-19 pandemic.

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Clinical Trials Clinical Trials Trials FDA Approval 72

Pharmaceutical Technology

AUGUST 8, 2022

The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. Enhertu-treated subjects had a median overall survival (OS) of 23.4

FDA Approval 265

FDA Approval HR Clinical Trials Clinical Trials 265

Pharmaceutical Technology

MAY 29, 2023

Lexicon senior vice president and chief medical officer Dr Craig Granowitz said: “With today’s FDA approval, Inpefa is now a valuable option for physicians to consider when treating patients transitioning out of the hospital and working to break the cycle of repeated hospitalisation.”

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FDA Approval Trials Medicine Drugs 246

Pharmaceutical Technology

NOVEMBER 18, 2022

Tzield was evaluated in the placebo-controlled, double-blind, randomised, event-driven TN-10 clinical trial, for delaying T1D (Stage 3, or clinical T1D) in Stage 2 T1D patients. Provention Bio stated that Tzield delayed the median onset of Stage 3 T1D by 25 months, or nearly two years, compared to a placebo in a clinical trial.

FDA Approval 246

FDA Approval Clinical Trials Clinical Trials Antibody 246

XTalks

DECEMBER 19, 2024

It includes Roches Alecensa (alectinib), Takedas Alunbrig (brigatinib) and Pfizers third-generation Lorbrena (lorlatinib), which have all surpassed Xalkori in performance, leading to their respective FDA approvals for first-line treatment. This figure later increased to 57 percent in the trials final PFS analysis.

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FDA Approval Marketing Trials Drugs 98

Pharmaceutical Technology

FEBRUARY 20, 2023

The regulatory approval is based on positive data obtained from the Phase III OAKS and DERBY trials, which were conducted across a broad and representative population of GA patients. The post US FDA approves Apellis’ geographic atrophy therapy Syfovre appeared first on Pharmaceutical Technology.

FDA Approval 246

FDA Approval Trials Drugs 246

Pharmaceutical Technology

JULY 8, 2022

In a Phase III ExteNET clinical trial, neratinib offered a 34% decline in the risk of recurrence and a 2.3% The trial demonstrated that after a median follow-up of 5.2 The post Specialised Therapeutics’ breast cancer drug gets Philippines FDA approval appeared first on Pharmaceutical Technology.

FDA Approval 246

FDA Approval HR Drugs Hormones 246

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted approval for Blueprint Medicines’ Ayvakit (avapritinib) as the first and only treatment for indolent systemic mastocytosis (ISM) in adult patients. The regulatory approval was based on the data obtained from the placebo-controlled, double-blind PIONEER trial.

FDA Approval 246

FDA Approval Medicine Trials Drugs 246

Pharmaceutical Technology

JUNE 9, 2023

Findings from the long-term extension ESSENCE-2 OLE trial showed that CyclASol’s effect was maintained and improved for most endpoints over a treatment period of 52 weeks. Novaliq medical science and regulatory affairs vice-president Sonja Krösser stated: “We are proud that the FDA approved VEVYE.

FDA Approval 246

FDA Approval Bioavailability Containment Drugs 246

Bio Pharma Dive

JUNE 4, 2024

A group of independent experts wasn't convinced by clinical trial data from company Lykos Therapeutics, which is seeking FDA approval of MDMA-assisted treatment for post-traumatic stress disorder.

FDA Approval 329

FDA Approval Clinical Trials Clinical Trials Trials 329

Pharmaceutical Technology

SEPTEMBER 19, 2022

bluebird bio was granted a rare paediatric priority review voucher following approval. The latest development is based on findings from the single-arm, open-label Phase II/III ALD-102 (Starbeam) and Phase III ALD-104 clinical trials. 1) in Skysona-treated and untreated subjects. “For thalassemia.

FDA Approval 246

FDA Approval In-Vivo Gene Therapy Clinical Trials 246

Pharmaceutical Technology

JULY 4, 2023

The gene therapy prevents neovascularisation from a single, intravitreally delivered injection.

FDA Approval 243

FDA Approval Gene Therapy Gene Trials 243

Bio Pharma Dive

OCTOBER 16, 2024

Alongside immunotherapy or chemo, the wearable device helped patients live longer in a trial, though the results are somewhat controversial.

FDA Approval 256

FDA Approval Trials 256

Pharmaceutical Technology

APRIL 30, 2024

The FDA granted accelerated approval for the drug back in September 2021 following positive Phase II trial data.

FDA Approval 246

FDA Approval Trials Drugs 246

Pharmaceutical Technology

OCTOBER 17, 2024

The company’s keratoconus medication, Epioxa, was effective in a Phase III trial, with plans to file for submission with the US Food and Drug Administration (FDA).

FDA Approval 246

FDA Approval Trials Drugs 246

Bio Pharma Dive

APRIL 27, 2023

Trial participants lost up to 15% of their body weight in a finding that should help the closely watched GLP-1 drug gain an FDA approval for obesity.

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FDA Approval Drugs Trials 318

Bio Pharma Dive

JUNE 8, 2021

Two near identical clinical trials of Aduhelm yielded conflicting results, dividing experts and even FDA staff. A third, confirmatory study is required, but Biogen has until 2029 to finish it.

FDA Approval 292

FDA Approval Clinical Trials Clinical Trials Trials 292

Pharmaceutical Technology

MARCH 23, 2023

The approval from the FDA was based on the data obtained from the multiregional, open-label, single-arm POD1UM-201 trial, conducted in metastatic or recurrent locally-advanced MCC adults who did not receive systemic therapy previously for their advanced disease.

FDA Approval 245

FDA Approval Licensing Licensing Antibody 245

Pharmaceutical Technology

MARCH 13, 2023

It increased the branching of dendrites and synaptic plasticity signals in animal trials. Daybue is claimed to be the first and only drug to receive approval to treat Rett syndrome, a complex, rare neurodevelopmental disorder that affects 6,000 to 9,000 patients in the US.

FDA Approval 183

FDA Approval Trials Drugs 183

Pharmaceutical Technology

JUNE 1, 2023

The US Food and Drug Administration (FDA) has granted a combination of AstraZeneca and MSD ’s Lynparza (olaparib), with standard therapies for treating BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Safety and tolerability were in line with that observed in prior trials and the known profiles of the medicines.

FDA Approval 244

FDA Approval Hormones Trials Clinical Trials 244

XTalks

NOVEMBER 15, 2024

Syros Pharmaceuticals announced that its cancer drug tamibarotene failed to meet its primary endpoint in the SELECT-MDS-1 Phase III trial. The placebo-controlled SELECT-MDS-1 trial involved 190 patients with complete response rate (CRR) being the study’s primary endpoint. percent and 18.8

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Trials HR Immune Response FDA Approval 105

Pharmaceutical Technology

AUGUST 16, 2024

The FDA approval of Imfinzi in this indication comes a month after the agency called for an overhaul of perioperative lung cancer trials.

FDA Approval 263

FDA Approval Trials 263

XTalks

FEBRUARY 25, 2025

Mirum Pharmaceuticals, a biotech innovator known for developing therapies for rare metabolic disorders, now has FDA approval for its new treatment, Ctexli (chenodiol) tablets the first and only medication approved for cerebrotendinous xanthomatosis (CTX) in adults.

FDA Approval 59

FDA Approval Gene Therapy Gene Genetics 59

Bio Pharma Dive

MARCH 30, 2021

The drugmaker's pill fell short on a critical safety measure in two large trials last fall. That result, and the surprisingly close FDA scrutiny of a rival medicine from FibroGen, makes the approval prospects of both treatments uncertain.

FDA Approval 242

FDA Approval Medicine Drugs Trials 242

Pharmaceutical Technology

AUGUST 8, 2022

At week 24, both SPIRIT trials met the co-primary endpoints, with 75% of women receiving Myfembree having a clinically meaningful decline in dysmenorrhea versus 27% and 30% of women in the placebo arms, respectively. . The post US FDA approves Pfizer-Myovant’s Myfembree for endometriosis pain appeared first on Pharmaceutical Technology.

FDA Approval 190

FDA Approval Drugs Trials Marketing 190

Pharmaceutical Technology

JUNE 21, 2023

It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator. The regulatory approval was based on the findings obtained from a double-blind, multinational, placebo-controlled, randomised clinical trial conducted in 5,522 chronic coronary disease patients.

FDA Approval 246

FDA Approval Cardiology Clinical Trials Clinical Trials 246

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 12, 2023

The US Food and Drug Administration (FDA) on Wednesday announced it had approved Eli Lilly’s highly anticipated weight loss drug Zepbound, the latest entrant in a field of powerful – and lucrative – new obesity medicines.​

FDA Approval 245

FDA Approval Drugs Medicine Clinical Trials 245

Pharmaceutical Technology

JANUARY 30, 2023

Eli Lilly and Company ’s (Lilly) oncology unit Loxo@Lilly has secured the US Food and Drug Administration (FDA) approval for Jaypirca (pirtobrutinib) to treat relapsed or refractory mantle cell lymphoma (MCL). Lilly stated that the continued approval of Jaypirca for this indication is based on clinical benefit in a confirmatory trial.

FDA Approval 148

FDA Approval Trials Drugs Development 148

Pharmaceutical Technology

FEBRUARY 13, 2023

Pfizer has received the US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for Cibinqo (abrocitinib) to treat a type of atopic dermatitis (AD). The label expansion for Cibinqo was supported by the data obtained from the placebo-controlled, randomised Phase III JADE TEEN clinical trial.

FDA Approval 148

FDA Approval Trials Clinical Trials Clinical Trials 148

Pharmaceutical Technology

AUGUST 29, 2022

The approval was based on findings from the multicentre, open-label, single-arm Phase II FIGHT-203 clinical trial that assessed the safety and efficacy of Pemazyre in 28 adult patients with r/r MLNs with FGFR1 rearrangement. In the trial, the median time to response of CR was 104 days and the median duration of CR was not attained.

FDA Approval 148

FDA Approval Clinical Trials Clinical Trials Trials 148

Pharmaceutical Technology

APRIL 9, 2024

The Phase I/II trial will assess iadademstat in combination with immune checkpoint inhibitors in lung cancer patients.

FDA Approval 130

FDA Approval Trials 130

Pharmaceutical Technology

MAY 11, 2023

The submission of sNDA was based on the data obtained from two placebo-controlled, double-blind, fixed-dose, randomised 12-week Phase III trials. The trials assessed the frequency of agitation symptoms in Alzheimer’s dementia patients, based on the Cohen-Mansfield agitation inventory (CMAI) total score.

FDA Approval 148

FDA Approval Trials Regulation Drugs 148