Pharmaceutical Technology

JULY 8, 2022

Specialised Therapeutics’ oral drug, Nerlynx (neratinib) has obtained the Philippines Food and Drug Administration approval to lower the recurrence or mortality risk in early-stage HER2-positive (HER2+) breast cancer patients. The trial demonstrated that after a median follow-up of 5.2

FDA Approval 246

FDA Approval HR Drugs Hormones 246

Pharmaceutical Technology

DECEMBER 1, 2022

The US Food and Drug Administration (FDA) has granted approval for Ferring Pharmaceuticals’ faecal microbiota product, Rebyota, to prevent Clostridioides difficile infection (CDI) recurrence in people aged 18 years and above. A live biotherapeutic, Rebyota is intended for usage following the completion of antibiotic treatment.

FDA Approval 264

FDA Approval Trials Clinical Development Development 264

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.

FDA Approval 315

FDA Approval Drugs Trials 315

Pharmaceutical Technology

AUGUST 12, 2022

The US Food and Drug Administration (FDA) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (fam-trastuzumab deruxtecan-nxki) to treat unresectable or metastatic non-small cell lung cancer (NSCLC) in adults. In the trial, 1.9% In the trial, 1.9%

FDA Approval 264

FDA Approval Clinical Trials Clinical Trials Engineer 264

Pharmaceutical Technology

MARCH 1, 2023

The US Food and Drug Administration (FDA) has granted approval for Regeneron Pharmaceuticals and Sanofi ’s Kevzara (sarilumab) to treat polymyalgia rheumatica (PMR) in adult patients. The post US FDA approves Regeneron-Sanofi’s Kevzara to treat polymyalgia rheumatica appeared first on Pharmaceutical Technology.

FDA Approval 245

FDA Approval Clinical Trials Clinical Trials Trials 245

Pharmaceutical Technology

MARCH 10, 2023

The US Food and Drug Administration (FDA) has granted approval for Pfizer ’s Zavzpret (zavegepant) for the acute treatment of migraine in adult patients with or without aura. Zavzpret is claimed to be the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray approved to treat migraine.

FDA Approval 246

FDA Approval Pharmacy Trials Clinical Development 246

Pharmaceutical Technology

JANUARY 9, 2023

Eisai and Biogen have received approval for their antibody Leqembi (lecanemab-irmb) , 100mg/mL injection for intravenous use, from the US Food and Drug Administration (FDA) under the Accelerated Approval Pathway to treat Alzheimer’s disease (AD).

FDA Approval 246

FDA Approval Antibody Clinical Trials Clinical Trials 246

Pharmaceutical Technology

MAY 29, 2023

Lexicon Pharmaceuticals (Lexicon) has received approval from the US Food and Drug Administration (FDA) for its Inpefa drug to treat heart failure. The SOLOIST-WHF (worsening heart failure) and SCORED trials together assessed around 12,000 patients.

FDA Approval 246

FDA Approval Trials Medicine Drugs 246

Pharmaceutical Technology

FEBRUARY 2, 2023

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). dL) for the patients.

FDA Approval 264

FDA Approval Life Science Genetics Trials 264

XTalks

DECEMBER 19, 2024

The US Food and Drug Administration (FDA) has approved ensartinib, a next-generation anaplastic lymphoma kinase (ALK) inhibitor, as a first-line treatment for patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). This figure later increased to 57 percent in the trials final PFS analysis.

FDA Approval 98

FDA Approval Marketing Trials Drugs 98

Pharmaceutical Technology

AUGUST 8, 2022

AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. Enhertu-treated subjects had a median overall survival (OS) of 23.4

FDA Approval 264

FDA Approval HR Clinical Trials Clinical Trials 264

Pharmaceutical Technology

JUNE 9, 2023

Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% It has been designed to address the unmet needs of patients and to provide quick action and well-tolerated dry eye drug therapy.

FDA Approval 246

FDA Approval Bioavailability Containment Drugs 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

NOVEMBER 18, 2022

The US Food and Drug Administration (FDA) has approved Provention Bio’s biologics licence application (BLA) for Tzield (teplizumab-mzwv) to treat type 1 diabetes (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

Pharmaceutical Technology

APRIL 27, 2023

Seres Therapeutics and Nestlé Health Science have received approval from the US Food and Drug Administration (FDA) for Vowst (faecal microbiota spores, live-brpk) for preventing the recurrence of C difficile infection (CDI) in adults. It is not indicated to treat CDI.

FDA Approval 246

FDA Approval Regulation Trials Development 246

Pharmaceutical Technology

FEBRUARY 20, 2023

The US Food and Drug Administration (FDA) has granted approval for Apellis Pharmaceuticals’ Syfovre (pegcetacoplan injection) to treat geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD). Syfovre reduced the GA lesion growth rate compared to sham injections in both the OAKS and DERBY studies.

FDA Approval 246

FDA Approval Trials Drugs 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

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 289

FDA Approval Clinical Trials Clinical Trials Trials 289

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

XTalks

NOVEMBER 7, 2024

Galderma’s doxycycline drug Oracea (doxycycline 40 mg capsules) is the current standard-of-care treatment for rosacea. Emrosi’s approval was based on data from a pair of Phase III clinical trials for the treatment of rosacea. Other studies suggest that Helicobacter pylori bacteria infections may also cause rosacea.

FDA Approval 105

FDA Approval Dermatology Bacteria Clinical Trials 105

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

Pharmaceutical Technology

APRIL 27, 2023

Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) to expand the use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to treat cystic fibrosis (CF) in children aged between two and five years with certain mutations.

FDA Approval 246

FDA Approval In-Vitro Drugs Gene 246

Pharmaceutical Technology

SEPTEMBER 19, 2022

The US Food and Drug Administration (FDA) has awarded Accelerated Approval for bluebird bio ’s Skysona (elivaldogene autotemcel; eli-cel) for slowing neurologic dysfunction progression in early, active cerebral adrenoleukodystrophy (CALD) patients. The treatment is indicated for usage in boys aged four to 17 years with CALD.

FDA Approval 246

FDA Approval In-Vivo Gene Therapy Clinical Trials 246

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 239

FDA Approval Medicine Drugs Trials 239

XTalks

APRIL 1, 2025

XTALKS WEBINAR: Keys to Success in Clinical Trials: A Strategic Guide for Biotechs and Startups Live and On-Demand: Thursday, May 22, 2025 , at 11am EDT (5pm CEST / EU-Central) Register for this free webinar to learn how biotechs can navigate endpoint challenges in clinical trials and accelerate their path to drug approval.

FDA Approval 59

FDA Approval RNA Clinical Trials Clinical Trials 59

World of DTC Marketing

AUGUST 27, 2021

SUMMARY: Over half of all clinical trial sites are outside the U.S. 87 % of all subjects in recent biologics trials were enrolled outside the U.S. DTC may or may not work for clinical trial enrollment it really depends on the condition and risk as judged by the patient. 78 % of all subjects were enrolled outside the U.S.

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Clinical Trials Clinical Trials Trials Drugs 187

Pharmaceutical Technology

MARCH 13, 2023

The US Food and Drug Administration (FDA) has granted approval for Acadia Pharmaceuticals ’ Daybue (trofinetide) to treat Rett syndrome in adult and paediatric patients aged two years and above. It increased the branching of dendrites and synaptic plasticity signals in animal trials.

FDA Approval 182

FDA Approval Trials Drugs 182

Pharmaceutical Technology

MARCH 23, 2023

The US Food and Drug Administration (FDA) has approved Incyte ’s Zynyz (retifanlimab-dlwr) to treat metastatic or recurrent locally advanced merkel cell carcinoma (MCC) in adult patients. Incyte is grateful to the investigators and patients around the world who participated in the POD1UM-201 trial. “We

FDA Approval 245

FDA Approval Licensing Licensing Antibody 245

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

Trials 105

Trials HR Immune Response FDA Approval 105

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). Trials peaked at 115 in 2018 before declining to 91 last year.

FDA Approval 244

FDA Approval Hormones Trials Clinical Trials 244

Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The FDA’s review will take into account data from the Phase III MOMENTUM trial (NCT04173494).

Drugs 246

Drugs FDA Approval Development Production 246

XTalks

JANUARY 29, 2025

The FDA has approved Novo Nordisks Ozempic (semaglutide) for reducing the risk of kidney failure, progression of kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD). The approval marks Ozempic as the first GLP-1 receptor agonist (GLP-1 RA) authorized in a kidney disease indication.

FDA Approval 66

FDA Approval Trials Clinical Trials Clinical Trials 66

Pharmaceutical Technology

AUGUST 8, 2022

The US Food and Drug Administration (FDA) has granted approval for Pfizer and Myovant Sciences ’ Myfembree (relugolix 40mg, estradiol 1mg and norethindrone acetate 0.5mg) to manage moderate-to-severe pain linked with endometriosis in pre-menopausal women.

FDA Approval 189

FDA Approval Drugs Trials Marketing 189

Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator. mg tablet) to treat cardiovascular disease.

FDA Approval 246

FDA Approval Cardiology Clinical Trials Clinical Trials 246

World of DTC Marketing

JUNE 6, 2021

SUMMARY: The media headlines promise weight loss for diabetes patients, but Norvo’s new drug is in the same class as other drugs and carries many warnings. Can diabetes patients really stay adherent to a drug for 63 weeks in which 85% of patients report GI side effects and will insurance cover the cost?

Drugs 318

Drugs Cosmetics Production FDA Approval 318

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

Pharmaceutical Technology

SEPTEMBER 6, 2022

The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. This status offers the drug developer some incentives, such as market exclusivity for seven years on obtaining FDA approval.

Drugs 246

Drugs FDA Approval Clinical Trials Clinical Trials 246