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

Bio Pharma Dive

SEPTEMBER 1, 2022

Approval of Xenpozyme, a treatment for a form of Niemann-Pick disease, comes with a valuable priority review voucher for Sanofi.

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FDA Approval Research Drugs 204

Bio Pharma Dive

SEPTEMBER 26, 2023

Once valued at more than $7 billion, the liver drug company couldn’t secure a long-sought FDA approval in NASH and last month said it would abandon that research.

FDA Approval 278

FDA Approval Drugs Research 278

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.

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FDA Approval RNA Clinical Trials Clinical Trials 59

Bio Pharma Dive

JUNE 16, 2023

The approval of Columvi adds another “bispecific antibody” to the market, highlighting the fast research progress for drugs that target two proteins rather than one.

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FDA Approval Drugs Protein Antibody 177

Pharmaceutical Technology

MAY 10, 2023

Gilead Sciences has emerged victorious in a legal battle with the US government over patents surrounding the HIV pre-exposure prophylaxis (PrEP) drugs Descovy and Truvada following a federal jury’s verdict on May 9. This research dates to the mid-2000s when CDC scientists developed the PrEP regimen, argued the government.

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Drugs FDA Approval Containment Licensing 264

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.

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FDA Approval Gene Therapy Gene Genetics 59

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.

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FDA Approval Hormones Trials Clinical Trials 244

Pharmaceutical Technology

JUNE 29, 2022

The US Food and Drug Administration (FDA) put a high-profile bluebird bio trial for sickle cell disease on partial clinical hold, and advisory panels deliberated over decisions involving gene therapies for amyotrophic lateral sclerosis (ALS), cerebral adrenoleukodystrophy (CALD), and beta-thalassemia.

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Drugs FDA Approval Development Marketing 246

Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth.

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Drugs FDA Approval Clinical Trials Clinical Trials 243

Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth.

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Drugs FDA Approval Clinical Trials Clinical Trials 239

XTalks

FEBRUARY 19, 2025

Deciphera leverages its proprietary switch-control kinase inhibitor platform targeting kinase activation to develop orally administered drug candidates, reflecting its commitment to innovative treatments for conditions with limited therapeutic options. The dynamic landscape of TGCT research extends beyond Decipheras efforts.

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FDA Approval Drugs Trials Clinical Trials 59

Pharmaceutical Technology

FEBRUARY 13, 2023

While several therapeutics are available for treating symptoms associated with epilepsy, researchers and patients have strongly called out the need for more holistic treatments that would address the condition as a whole. Meanwhile, others are researching the link between gene variation and different responses to treatments.

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Research Gene Gene Therapy Genome 264

XTalks

JANUARY 21, 2025

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Agent drug-coated balloon. The balloons outer surface is coated with the drug paclitaxel, a safe and effective measure to prevent the arteries from narrowing again.

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FDA Approval Manufacturing Development RNA 105

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 14, 2023

The US Food and Drug Administration has approved a fast-acting nasal spray from Pfizer designed to treat migraines, the US pharmaceutical giant said Friday.

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FDA Approval Pharmacy Marketing Drugs 246

Pharmaceutical Technology

APRIL 11, 2023

The US Food and Drug Administration (FDA) has granted final approval to India-based Zydus Lifesciences ‘ 500mg azithromycin tablets for the treatment of bacterial infections. Zydus will manufacture the drug at its formulation facility in Moraiya, Ahmedabad, in the Indian state of Gujarat.

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FDA Approval Drugs Immune Response Manufacturing 130

Pharmaceutical Technology

OCTOBER 10, 2022

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Boostrix (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed [Tdap]) for pregnant women during their third trimester to prevent pertussis (whooping cough) in newborn infants.

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FDA Approval Vaccination Vaccine Antibody 147

World of DTC Marketing

AUGUST 27, 2021

The FDA approved 309 new drugs between 2011 and 2018, 38 per year on average. In 2018, the FDA approved 59 new drugs – an all-time high. The industry loses an average of $40 billion per year on drug development, part of which is due to trial delays. Does this mean DTC won’t work?

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Clinical Trials Clinical Trials Trials Drugs 187

Pharmaceutical Technology

JUNE 14, 2023

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS).

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FDA Approval Genetics Trials Medicine 130

pharmaphorum

MAY 16, 2022

Blood sugar control drug Mounjaro has been granted US regulatory approval, giving type 2 diabetics another way to help keep their glucose levels in check. The drug is injected under the skin once a week and the dose can be adjusted to meet an individual’s blood sugar needs.

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FDA Approval Insulin Drugs Hormones 115

pharmaphorum

AUGUST 21, 2020

It’s mission accomplished for Novartis after the FDA approved ofatumumab for multiple sclerosis, completing a project where the former cancer drug has been repurposed. The FDA approved ofatumumab under the brand name Kesimpta for people living with relapsing forms of multiple sclerosis.

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FDA Approval Branding Drugs Marketing 116

pharmaphorum

DECEMBER 19, 2022

The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firedenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours.

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Gene Therapy FDA Approval Gene Drugs 119

Pharmaceutical Technology

MAY 22, 2023

The US Food and Drug Administration (FDA) has granted approval to AbbVie and Genmab ‘s Epkinly (epcoritamab-bysp) to treat relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adult patients. The FDA approval of Epkinly represents a new treatment mechanism of action for third-line DLBCL patients.

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FDA Approval Clinical Trials Clinical Trials Antibody 130

Pharmaceutical Technology

AUGUST 25, 2022

The US Food and Drug Administration (FDA) has gra nted approval for AbbVie and Janssen Biotech’s Imbruvica (ibrutinib) to treat chronic graft versus host disease (cGVHD) in paediatric patients aged one year and above. Imbruvica is indicated for such patients following failure of one or more lines of systemic therapy.

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FDA Approval Clinical Trials Clinical Trials Protein 130

XTalks

FEBRUARY 15, 2023

Polarean is a medical imaging company focused on improving the state of lung imaging that recently received FDA approval for its drug-device combination product, Xenoview. Tune into the episode to learn more about the FDA approval of Xenoview, including the journey to its approval.

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Life Science FDA Approval Drugs Production 98

XTalks

MAY 5, 2022

Supernus Pharmaceuticals’ Qelbree was approved by the FDA on Friday. Qelbree is the newest nonstimulant ADHD drug for adults after two decades. The US Food and Drug Administration (FDA) has approved two classes of drugs for the treatment of ADHD: stimulants and nonstimulants.

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FDA Approval Drugs Clinical Trials Clinical Trials 98

XTalks

JANUARY 6, 2025

The US Food and Drug Administration (FDA) has approved Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, to treat cystic fibrosis (CF) in patients aged six years and older with at least one F508del mutation or another responsive CFTR mutation.

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Gene Therapy Protein Genetic Disease Gene 105

World of DTC Marketing

NOVEMBER 24, 2021

needs to take substantial steps to address the high costs of cancer drugs. From 2009 to 2019, the median monthly treatment costs for new drugs at launch reached $11,755 in the U.S… From 2009-10 to 2018-19, the lowest average monthly costs for new cancer drugs approved by the U.S. SUMMARY: The U.S.

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Drugs FDA Approval Research Medicine 266

pharmaphorum

SEPTEMBER 16, 2022

Alphabet subsidiary and precision health company Verily recently announced a breakthrough in its AI drug discovery GPCR research collaboration with Sosei Heptares. The companies hope that in the year to come those data targets will be entered for validation, hit generation, and lead selection. What, then, is the solution?

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Development Research Drugs Clinical Trials 135

World of DTC Marketing

DECEMBER 13, 2021

Monthly drugs costs may reach $100,000, causing many Americans to struggle with the physical and emotional effects of high out-of-pocket medical costs. Some cancer patients may face out-of-pocket costs of nearly $12,000 a year for one drug. Research shows most cancers are preventable. What makes cancer such a financial killer?

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Drugs FDA Approval Medicine Containment 55

XTalks

SEPTEMBER 19, 2024

World Cancer Research Day 2024, observed on September 24, highlights innovation under the theme “Innovation In Cancer Research Drives Progress Toward Health Equity.” 2024 has seen significant US Food and Drug Administration (FDA) approvals that are pushing the boundaries of cancer treatment.

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Research Drugs FDA Approval Trials 97

XTalks

SEPTEMBER 14, 2022

Daxxify was FDA-approved for similar cosmetic purposes as Botox and other neuromodulators like Dysport and Xeomin. Used for both cosmetic and therapeutic cases, Botox is a US Food and Drug Administration (FDA)-approved injection of botulinum toxin, a neurotoxic protein that can effectively paralyze the facial muscles.

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Botox FDA Approval Cosmetics Clinical Trials 98

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has approved Neobiosis’ investigational new drug (IND) application for ViXome to treat post-Covid-19 syndrome (also known as long Covid). ViXome is an acellular product derived from amniotic fluid.

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FDA Approval Production Clinical Development Manufacturing 147

XTalks

NOVEMBER 30, 2023

Pfizer spinout SpringWorks Therapeutics’ Ogsiveo (nirogacestat) has received US Food and Drug Administration (FDA) approval for the treatment of desmoid tumors, an ultra-rare subtype of non-cancerous soft tissue sarcomas that can cause severe pain and disfigurement.

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FDA Approval Trials Clinical Trials Clinical Trials 101

XTalks

AUGUST 12, 2024

The US Food and Drug Administration (FDA) has approved ARS Pharmaceuticals’ neffy (epinephrine nasal spray) as the first non-needle emergency treatment of allergic reactions (Type I), including life-threatening ones like anaphylaxis, in adult and pediatric patients who weigh at least 66 pounds.

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FDA Approval Allergies Production Drugs 105

XTalks

NOVEMBER 13, 2024

XTALKS WEBINAR: Generative AI in Clinical Research: From Data to Patient Cohorts Live and On-Demand: Wednesday, December 11, 2024, at 1pm EST (10am PST) Register for this free webinar to learn how generative AI is revolutionizing clinical research from streamlining data abstraction to building more precise patient cohorts.

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Clinical Research FDA Approval Trials Research 105

XTalks

JANUARY 21, 2025

The FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate (ADC) for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer, developed through a global collaboration between Daiichi Sankyo and AstraZeneca. to 4,437 yen, reflecting investor confidence.

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Antibody FDA Approval HR Trials 105