Pharmaceutical Technology

JANUARY 24, 2023

The US Food and Drug Administration (FDA) has granted clearance for Neurogene’s investigational new drug (IND) application for NGN-401 to treat Rett syndrome. Neurogene stated that the FDA IND clearance allows it to commence a Phase II/II trial of NGN-401 in female paediatric Rett syndrome patients.

FDA 83

FDA Communication Labelling 83

Pharmaceutical Technology

APRIL 4, 2023

Vertex Pharmaceuticals and CRISPR Therapeutics have completed the rolling submission of biologics licence applications (BLAs) to the US Food and Drug Administration (FDA) for exagamglogene autotemcel (exa-cel) to treat sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).

FDA 98

FDA 98

Impact Pharmaceutical Services

SEPTEMBER 26, 2023

Download the PDF The post Navigating the FDA: YOUR GUIDE TO IND APPLICATIONS appeared first on SYNER-G.

FDA 59

FDA 59

pharmaphorum

JULY 7, 2022

Pfizer is still waiting for the green light to complete an acquisition of digital health company ResApp, a deal that looks even better now that its smartphone app for people with obstructive sleep apnoea (OSA) has been approved by the FDA. The post ResApp bags FDA okay for sleep apnoea app, after Pfizer takeover bid appeared first on.

FDA 105

FDA 105

Pharmaceutical Technology

JANUARY 31, 2023

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Moderna ’s investigational mRNA vaccine candidate, mRNA-1345, for respiratory syncytial virus (RSV) in adult patients. In August 2021, the US FDA granted Fast Track designation to mRNA-1345.

Vaccines 72

Vaccines FDA Communication 72

European Pharmaceutical Review

DECEMBER 21, 2022

The US Food and Drug Administration (FDA) created live biotherapeutic products (LBP) as a new category in the 2012 guidelines. EMA and FDA have given prime importance to the whole genome sequence characterisation of the strain in the final product dossier. Download and read more now… .

Documentation 111

Documentation FDA 111

Pharmaceutical Technology

MAY 26, 2023

By Cytiva Thematic By downloading this case study, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy

FDA 105

FDA 105

Pharma Marketing Network

MARCH 18, 2025

Conversion Rate: Tracks how many users complete a desired action, such as signing up for a webinar or downloading whitepapers. Using Google Display Network, LinkedIn, or eHealthCare Solutions , brands can: Show relevant ads to HCPs who viewed but didnt download resources. Avoiding misleading claims that exaggerate efficacy or safety.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies FDA Documentation 52

Pharma Marketing Network

MARCH 8, 2025

Optimize landing pages to ensure message consistency and compliance with FDA regulations. FDA and HIPAA Compliance in PPC Fair balance requirements Ads must include benefits and risks equally. No unapproved drug claims All claims must be backed by clinical research and FDA-approved labeling.

HIPAA 59

HIPAA Pharmaceutical Companies Pharmaceutical Companies FDA 59

The FDA Law Blog

DECEMBER 12, 2022

Baumhardt, Senior Medical Device Regulation Expert — With the explosion of health‑related software, many software developers are generating products with functionality that is subject to regulation by the Food and Drug Administration (FDA). Please check out FDA’s presentation on this very topic – Is My Product a Medical Device?

Documentation 23

Documentation FDA Communication 23

Pharma Marketing Network

APRIL 2, 2025

For instance, knowing whether oncologists prefer digesting content via short videos or downloadable clinical summaries can dictate resource allocation. In 2025, marketing in pharma demands a careful balance between creativity and strict adherence to FDA and international marketing regulations. Data can also guide channel optimization.

Communication 64

Communication FDA 64

Pharmaceutical Technology

JANUARY 16, 2023

The US Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations to the company’s zevor-cel in 2019. By clicking the Download Free Whitepaper button, you accept the terms and conditions and acknowledge that your data will be used as described in the Cytiva Thematic privacy policy.

Communication 119

Communication FDA 119

European Pharmaceutical Review

JUNE 27, 2023

AC Immune SA has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy vaccine candidate for Alzheimer’s disease.

Vaccines 105

Vaccines Immunization FDA 105

ISPE

MAY 1, 2023

Any violations concerning data integrity would lead to several regulatory actions like warning letters and alerts that are issued by the FDA. Since many international regulatory agencies are focusing on data integrity, FDA auditors are being trained to recognize data integrity issues in a more effective way.

FDA 98

FDA Communication 98

pharmaphorum

DECEMBER 22, 2022

The Parma site is due to become operational from 2024, with FDA, IFA, and EMA approvals due to be sought for 2025. In brief, the European plan for Chiesi is in-house drug development of biologicals and rare disease targeting.

FDA 98

FDA 98

pharmaphorum

JUNE 8, 2022

Users can also use the built-in health records feature on the Health app to download current medications, said Ricky Bloomfield, a former director of mobile strategy at Duke University who joined Apple as clinical and health informatics lead in 2016 in a tweet.

Documentation 131

Documentation Labelling FDA 131

Pharmaceutical Technology

JANUARY 31, 2023

The gene therapy received Orphan Drug and Fast Track designations from the US Food and Drug Administration (FDA). It includes a recombinant AAVrh10 vector that expresses a micro ribonucleic acid (miRNA) which reduces the expression of SOD1 to slow down or reverse ALS progression in SOD1 mutation patients.

Communication 111

Communication FDA 111

Pharmaceutical Technology

MAY 4, 2023

After a winter marked by a rise in hospitalisations due to the RSV, the FDA has granted its first approval for an Respiratory Syncytial Virus (RSV) vaccine to GSK’s Arexvy for adults ages 60 years and above. These recommendations and the FDA approval were based on positive AReSVi-006 Phase III trial data.

Vaccines 64

Vaccines FDA Communication Immunization 64

pharmaphorum

MAY 5, 2022

Or you can download the free guide below: “CDISC standards required for regulatory submission” DOWNLOAD FREE GUIDE. Why CDISC standards should never be ignored in any clinical trial: The use of CDISC standards allows externals to understand clinical trial data FAST.

FDA 98

FDA 98

Pharmaceutical Technology

MARCH 8, 2023

Currently, there are six CAR T cell therapies that received approval from the US Food and Drug Administration (FDA) and approximately 560 programmes in ongoing studies. The new technologies will also overcome the manufacturing bottlenecks in delivering advanced engineered cell products.

Communication 97

Communication FDA 97

Pharmaceutical Technology

MAY 24, 2023

It also provides the ability for early FDA interactions, support accelerated approvals and priority review of biologics licensing applications. The RMAT designation programme is intended to accelerate the drug’s development and review processes for products, including gene therapies.

FDA 52

FDA 52

Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. In its 2022 annual report on generics, the US FDA stated it had approved 106 first generics, which it claimed would offer significant cost savings for patients. from 2001 to 2022.”

FDA 98

FDA Generic Medicine Communication 98

Pharmaceutical Technology

MAY 24, 2023

Innoviva has snagged a win for its bacterial pneumonia drug Xacduro (durlobactam sodium + sulbactam) with a US Food and Drug Administration FDA approval for use in patients of ages 18 or older. The FDA approval stemmed from results from Entasis’ Phase III Attack trial (NCT03894046). Please check your email to download the Report.

FDA 52

FDA Communication Hospitals 52

Pharmaceutical Technology

MAY 24, 2023

The AMP programme is a public-private partnership between a number of biopharmaceutical and life sciences companies, the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH), along with non-profit and other organisations. Shilling was appointed to represent the company on the steering committee of the BGTC.

FDA 96

FDA 96

pharmaphorum

APRIL 26, 2022

With new regulations, including the 2021 guidance’s by the European Medicines Agency and US FDA emphasising the need for greater representation, addressing this issue is now even more vital for clinical researchers. Read and download the full Achieving diversity, equity and inclusion in clinical trials whitepaper.

FDA 98

FDA 98

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted Centessa Pharmaceuticals’ activated Protein C (APC) inhibitor SerpinPC a fast track designation for treating haemophilia B. The FDA’s fast track designation is designed to speed up the regulatory process to allow faster drug development and review to fill unmet needs.

FDA 59

FDA Communication Labelling 59

Pharmaceutical Technology

JUNE 20, 2023

UK-based biotech F2G was dealt a blow as the US’ FDA issued a complete response letter rejecting its latest new drug application (NDA). F2G claimed in a June statement that the FDA requested additional data and analysis that extended beyond the current review period. Please check your email to download the Report.

FDA 52

FDA Packaging Communication Labelling 52

Pharmaceutical Technology

MAY 22, 2023

The US Food and Drug Administration (FDA) has granted approval for Krystal Biotech’s Vyjuvek (beremagene geperpavec-svdt) to treat dystrophic epidermolysis bullosa (DEB) in patients aged six months and above. Vyjuvek is a non-invasive, topical, re-dosable gene therapy that delivers functional human COL7A1 gene copies to offer wound healing.

FDA 52

FDA 52

Pharmaceutical Technology

MAY 15, 2023

The US Food and Drug Administration (FDA) has given orphan drug designation to SiSaf’s siRNA [a double-stranded RNA molecule that is non-coding] therapeutic, SIS-101-ADO, for the treatment of autosomal dominant osteopetrosis type 2 (ADO2), a rare and serious skeletal disorder in children.

FDA 52

FDA 52

pharmaphorum

OCTOBER 7, 2020

SMi Reports: An exclusive interview with María José López Barragán, Founder, Barragan BioConsulting, formerly CMC Product Quality Reviewer, FDA, who will be speaking at the 3rd Annual Pharmaceutical Microbiology East Coast Conference released. The full interview can be downloaded at: www.pharma-microbiology.com/PR9.

FDA 52

FDA Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has released the fourth and final chapter in a series of guidance documents designed to support patient-focused drug development. The guidance also touched upon clinical trial design elements that must be explained, described, or rationalised to the FDA.

FDA 52

FDA Documentation Communication 52

pharmaphorum

JANUARY 25, 2021

Although the FDA has noted that the development of and access to rare disease treatments remains a top priority during the pandemic, generating data for these conditions is still highly challenging. DOWNLOAD THE FULL ARTICLE HERE. The post Real-world evidence: breaking boundaries in rare disease appeared first on.

FDA 88

FDA 88

ISPE

DECEMBER 14, 2022

Indeed, the narrative within Annex 1 has already been adopted by PIC/s, and with the close links to WHO and FDA, it will undoubtedly soon have a global reach. Download White Paper. To download this white paper, complete the form below. For further information, please visit www.ipsdb.com. . Company Name. Company Type.

Communication 98

Communication FDA 98

The Checkup by Singlecare

APRIL 17, 2024

Food and Drug Administration (FDA) approved Wegovy for adults and children 12 years and older who have a body mass index (BMI) of 30 or higher or who have a BMI of 27 or higher with a related medical condition, such as high blood pressure, Type 2 diabetes, or high cholesterol. Medicare prohibits Part D plans from covering certain medications.

Insurance 98

Insurance Insurance Coverage Pharmaceutical Companies Pharmaceutical Companies 98

The FDA Law Blog

DECEMBER 21, 2022

Baumhardt, Senior Medical Device Regulation Expert — In our previous blog post , we provided a flowchart for the Digital Health Policy Navigator’s process so that our blog readers can quickly review the seven steps in determining whether their product’s software functions may be potentially the focus of FDA oversight.

FDA 59

FDA 59

Pharmaceutical Technology

JUNE 9, 2023

The US Food and Drug Administration (FDA) has granted approval to commence commercial production at Bristol Myers Squibb’s new advanced cell therapy manufacturing facility in Devens, Massachusetts.

FDA 52

FDA 52

Pharmaceutical Technology

MAY 3, 2023

The US Food and Drug Administration (FDA) has granted Tenaya Therapeutics’ gene therapy TN-201 a fast track designation for the treatment of myosin binding protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM). In January 2023, Tenaya announced FDA clearance for its Investigational New Drug (IND) application for TN-201.

Mayo Clinic 97

Mayo Clinic FDA Communication Labelling 97