The Checkup by Singlecare

JULY 8, 2025

While it’s hard to say how many people are using Linzess right now, here’s what we know: Between 2012 and 2017, more than seven million prescriptions were filled for Linzess by 1.5 Since its FDA approval in 2012, the total money spent on Linzess has increased drastically. million unique patients. Ironwood Pharmaceutical Inc.

Insurance

PharmaVoice

JUNE 18, 2025

billion in sales that year, despite the FDA finding the ads “made unsupported and misleading claims of effectiveness and minimized its safety risks.” But a ban enacted through legislation is more likely to hold up in court than a policy change by the FDA. The bill will likely face legal challenges from the pharma industry.

Compounding

Pharmaceutical Technology

JUNE 18, 2025

The US Food and Drug Administration (FDA) has created a new priority review voucher (PRV) framework to expedite the drug approval process for pharma companies prioritising US interests. The PRV programme for rare paediatric diseases, signed into law in 2012, expired in late 2024 after it failed to make it into a US Congress funding package.

FDA

Pharmacy Times

JULY 29, 2025

For example, women have been shown to experience higher rates of adverse drug reactions than men, with evidence indicating that 80% of FDA drug withdrawals were linked to harmful effects in women. Specifically, psychology and psychiatry were among the disciplines where this increase was observed to be highest (P < 001).

Department of Veterans Affairs

The Thyroid Pharmacist

AUGUST 1, 2025

Thyroid Medication Safety During Pregnancy and Breastfeeding Thyroid medications are known to be safe during pregnancy and are rated by the FDA as a category A drug for pregnancy, which means there is no evidence of harm to the fetus. 2012 May 16;5(5):CD003519. 2012 Jul-Aug;41(4):580]. 2012 Jul;20(2):41-7. doi:10.1111/j.1552-6909.2012.01350.x;

Health and Personal Care Stores

Drug Topics

JULY 7, 2025

They conducted a national, population-based analysis of children in Denmark over a 10-year period lasting from 2012 to 2022. Focusing on the 3 aforementioned respiratory diseases, researchers’ goal was to explore the overall impact NPIs that emerged during the pandemic had on RSV, influenza, and invasive pneumococcal disease.

Independent Pharmacies

Pharmaceutical Technology

JUNE 18, 2025

Robert Barrie June 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Priority review vouchers are often bought by companies looking to dramatically reduce FDA review time for a new drug application. PRVs slash the FDA review time of a drug application from the usual ten months to six months.

FDA

The Checkup by Singlecare

AUGUST 6, 2025

Insurance companies are required by law to cover generic FDA-approved contraceptives. In addition, some health plans were grandfathered in when the laws were enacted in 2012 and may continue to deny coverage for birth control products. More specifically, they must cover at least one contraceptive in each category.

Insurance

European Pharmaceutical Review

APRIL 8, 2025

To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT. International Council for Harmonisation (ICH), 2012. Q9 Quality Risk Management.

Documentation

European Pharmaceutical Review

DECEMBER 23, 2024

The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA. November 2012. EU Official Says ICH Q6B Is Outdated And Needs Revision. Internet] Regulatory Focus. cited 2024August]. Available from: [link] 4. Pharmaceutics. 2021; 13(1): 48. ICH Q8(R2) Pharmaceutical Development – Scientific Guideline.

Vaccines

Drug Topics

APRIL 5, 2023

Data suggest confirmatory trials conducted for drugs granted accelerated approval by the FDA have taken over 3 years on average to complete since 2012.

FDA

Fierce Pharma

JULY 8, 2024

The traditional approvals follow initial accelerated approvals granted by the FDA in 2012 and the European Commission in 2014. It took many years, but Johnson & Johnson’s tuberculosis med Sirturo can finally claim full approvals in the U.S. and Europe following initial conditional nods. |

FDA

STAT

JULY 2, 2024

The Food and Drug Administration’s rare pediatric disease priority review voucher program , which has been providing incentives for lifesaving innovations since 2012, is doomed to disappear unless Congress reauthorizes it before the end of September. I have data showing it works. None worked. Read the rest…

Labelling

STAT

OCTOBER 2, 2023

” That train of thought — calculating risks, eliminating threats — eventually led her to a job with the Food and Drug Administration in 2012 as a public health analyst. And I thought, doesn’t that mean nobody should really be sliding down poles?”

Insurance

European Pharmaceutical Review

OCTOBER 10, 2022

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline Biologicals’ Boostrix vaccine for use in pregnant woman in their third trimester, to prevent against whooping cough (pertussis) in infants up to two months of age. Since 2012, the CDC has recommended the vaccine series during the third trimester of each pregnancy.

Vaccines

Pharmacy Times

DECEMBER 21, 2024

OraQuick was the first at-home HIV test kit to be approved by the FDA in 2012.

FDA

European Pharmaceutical Review

JANUARY 16, 2023

Under the agreement with the Swiss Confederation (Switzerland), the Swiss Agency for Therapeutic Products (Swissmedic) and the US Food and Drug Administration (FDA) will be able to utilise each other’s GMP inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections.

FDA

STAT

SEPTEMBER 12, 2024

Designed in 2012 to encourage drug development for rare childhood diseases, the program provides vouchers to groups who get a drug in that area approved. The voucher is like a fastpass at Disneyland, allowing whoever has it to request the FDA review a drug within six months, vs. the usual 10. Read the rest…

FDA

STAT

MAY 9, 2023

In 2012, Ranbaxy paid a $350 million fine to U.S. As a result, the company has halted exports from the plant to the United States. At issue is a facility Sun bought eight years ago from Ranbaxy Laboratories, which was a poster child for lax manufacturing standards in India.

FDA

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.

Documentation

The FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices.

FDA

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.

Vaccines

pharmaphorum

DECEMBER 8, 2020

That has resulted in 26 partnerships, but the poster child of AbCellera’s portfolio is its alliance with Lilly for bamlanivimab (LY-CoV555), which was approved by the FDA and Canadian regulator for emergency use as treatment for mild-to-moderate COVID-19 patients last month.

Immunization

Pharmaceutical Technology

MAY 10, 2023

The FDA approved Truvada as the first PrEP treatment in July 2012, with Descovy receiving a nod for this use in October 2019. Truvada has since gone generic, with Teva Pharmaceuticals launching the first FDA-approved Truvada generic in October 2020. Gilead markets both Truvada and its successor Descovy.

Pharmaceutical Companies

pharmaphorum

NOVEMBER 27, 2020

The new EU approval comes after the FDA approved the expanded label last year, and provides the first treatment option that tackles the underlying cause of CF in patients aged six to 11 with these mutations. Together these drugs cover the CFTR mutations seen in around half of all CF patients.

Labelling

pharmaphorum

MARCH 23, 2021

Safety has been an issue throughout development and in 2012 the FDA put tanezumab on clinical hold because of a class-related issue with joint destruction, which was finally lifted in 2015. Stopping the drug after progression to more serious disease does not appear to be effective in preventing further damage to joints, the FDA added.

FDA

Pharmaceutical Technology

SEPTEMBER 4, 2024

Between 2012 and 2021, outsourcing propensity for FDA NDA injectables approvals averaged 40%, according to GlobalData’s Contract Injectable Packaging Trends…

Packaging

European Pharmaceutical Review

APRIL 27, 2023

Growth has been rapid since Europe’s first gene therapy approval in 2012, 2 and the first US Food and Drug Administration (FDA) approval of a gene therapy in 2017. 3 Any sector would struggle to keep up with expansion of this speed, but the inherent difficulty of working with and producing biologics adds another layer of complexity.

FDA

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

FDA

Pharmaceutical Technology

AUGUST 2, 2024

Alemtuzumab, under the brand name Campath, was pulled from the leukaemia market by Sanofi in 2012.

FDA

pharmaphorum

NOVEMBER 11, 2022

Black/African American participation in trials has been declining over the past decade, says the report, falling from around 12% in 2012 to less than 10% in 2019 and 2020. For Hispanics, participation in trials increased from 7% in 2012 to a high of just under 10% in 2017 but fell back to levels of around 8% to 9% in the past two years.

FDA

The Checkup by Singlecare

OCTOBER 20, 2023

Another 2012 article suggests that a formula containing shilajit and vitamin B complex may be effective against Alzheimer’s disease. In a 2012 animal study , researchers induced chronic fatigue syndrome (CFS) in rats for 21 days. Supplements are not regulated by the Food and Drug Administration (FDA), so contamination is possible.

Immunization

The FDA Law Blog

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. By Véronique Li, Senior Medical Device Regulation Expert & Deborah L.

FDA

The FDA Law Blog

APRIL 30, 2023

Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. Subsection 505(q) initially was added by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub.

Immunization

pharmaphorum

JANUARY 18, 2021

Johnson & Johnson’s Darzalex Faspro has become the first product approved by the FDA to treat light chain (AL) amyloidosis, a rare and often fatal blood cell disorder.

Chemotherapy

pharmaphorum

SEPTEMBER 26, 2022

Other drugs used to treat ATL include Kyowa Kirin’s amti-CCR4 antibody Poteligeo (mogamulizumab), cleared by the MHLW for CCR4-positive ATL in 2012, as well as Bristol-Myers Squibb/Celgene’s oral therapy Revlimid (lenalidomide), which got a green light there five years ago.

Chemotherapy

The FDA Law Blog

AUGUST 10, 2023

Cato — On August 3rd, FDA issued 11 warning letters to foreign facilities registered as OTC drug manufacturers. For each of these facilities, FDA did not conduct an on-site inspection of the facility prior to issuing the warning letter. By McKenzie E.

FDA