PharmaShots

JUNE 12, 2025

Shots: The US FDA has approved mRESVIA (mRNA-1345) to prevent lower respiratory tract disease caused by RSV in individuals (18-59yrs.) at risk; expected to be available in US for the 2025–2026 respiratory virus season Approval was based on P-III trial assessing safety & immunogenicity of mRESVIA in adults (18-59yrs.)

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FDA 59

Outsourcing Pharma

SEPTEMBER 17, 2024

One year after a rejection by the US Food and Drug Administration (FDA), the UK firm F2G has raised $100 million to push its candidate olorofim to the market for the treatment of rare fungal infections in 2026.

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FDA 110

pharmaphorum

JULY 6, 2021

Novartis has tried to get its marketing application for high cholesterol therapy inclisiran in the US back on track, after the FDA rejected it last year, by changing the factory that makes the drug. billion in 2019, and will be hoping for a swift response from the FDA to get the programme back on track and recoup its investment.

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FDA 105

The FDA Law Blog

JANUARY 18, 2023

The memorandum outlines CMS’s priorities and timeline for the Initial Price Applicability Year 2026. The topics focus on issues relevant in the first three years of the Negotiation Program—2026 to 2028. Finally, the memorandum has a handy timeline of the key dates associated with the Initial Price Applicability Year 2026.

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Dosage 59

The FDA Law Blog

FEBRUARY 11, 2025

However, as we suggested in a recent blog post , the statute did not actually provide any limitations on FDAs authority to grant rare pediatric disease designations , only its authority to grant vouchers. In the meantime, the Pink Sheet confirmed that FDA was continuing to review rare pediatric disease designation requests.

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FDA 59

pharmaphorum

FEBRUARY 10, 2022

The FDA has granted fast-track status to Bayer’s oral Factor Xia inhibitor asundexian, which is in phase 2 testing as an anticoagulant that could offer safety advantages over current drugs. The post FDA fast tracks Bayer’s oral anticoagulant asundexian appeared first on.

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FDA 98

STAT

NOVEMBER 1, 2023

FDA staff said the new type of technology raised concerns about unintended genomic alterations that can potentially cause other side effects, but did not raise any concerns about efficacy. If the therapy is approved, Vertex has proposed a 15-year follow up of patients to evaluate the safety outcomes of the therapy.

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FDA 113

Pharmacy Times

MARCH 7, 2025

The treatment is currently undergoing evaluation in an investigational preclinical program and is projected to be in human trials in 2026.

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FDA 73

pharmaphorum

APRIL 29, 2021

Calliditas Therapeutics could have its first product on the market in the US this autumn, as the FDA has now started a priority review of Nefecon for rare disease primary IgA nephropathy (IgAN). . The post FDA sets September review date for Calliditas’ rare kidney disease drug appeared first on.

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pharmaphorum

MAY 28, 2025

Savara shares are pummelled after the FDA says it cannot accept a filing for lead drug Molbreevi, but it is still hopeful of an approval in 2026.

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FDA 45

pharmaphorum

AUGUST 6, 2020

The FDA has approved GlaxoSmithKline’s multiple myeloma drug Blenrep, a first-in-class potential blockbuster that will be used in advanced disease. The post FDA approves GSK’s Blenrep for advanced multiple myeloma appeared first on. Keratopathy leading to treatment discontinuation affected 2.1% of patients in the cohort.

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The FDA Law Blog

SEPTEMBER 16, 2024

Schwartz — FDA recently published a Federal Register (FR) Notice [ Docket No. FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies.

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Documentation FDA Communication 59

STAT

AUGUST 22, 2023

Jardiance, a diabetes medicine co-marketed by Boehringer, is expected to be among the first drugs to face negotiation once the law takes effect in 2026. Continue to STAT+ to read the full story…

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Vaccines Pharmaceutical Companies Pharmaceutical Companies FDA 98

STAT

JUNE 6, 2024

But the patent on semaglutide, the active ingredient in both drugs, expires in China in 2026. Ozempic won approval in China in 2021 and Novo Nordisk saw sales of the drug in that region double to $698 million last year. It expects Wegovy to be approved this year. Continue to STAT+ to read the full story…

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FDA 107

The FDA Law Blog

OCTOBER 13, 2024

A very important aspect of the program is that it costs FDA, and the government, no additional dollars, though we do not wish to minimize the additional resources a priority review demands over the standard review that such an application might otherwise receive.

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Documentation FDA 64

The FDA Law Blog

SEPTEMBER 22, 2024

Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. Prior to February 2, 2026, FDA also said that it does not intend to enforce complaint requirements under 21 CFR 820.198 for developers that are already in compliance with the complaint requirements under ISO 13485.

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The FDA Law Blog

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. FDA further retained some definitions in the QSMR. Revised § 820.3

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FDA Labelling Packaging Documentation 59

The FDA Law Blog

MARCH 19, 2024

AMDM is known for serving as a “connector” for FDA and other regulatory bodies to share information and exchange ideas with industry. Mullen brings to the AMDM board a wealth of knowledge and expertise gained from her years of providing counsel to medical device and IVD manufacturers. Speaking about her appointment, Ms.

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FDA 59

The FDA Law Blog

OCTOBER 12, 2023

Koblitz — For years, submitting a Suitability Petition has been like screaming into a void: You’d be lucky if FDA ever responds. This has been a big problem because FDA’s inattentiveness can delay entry of certain types of ANDAs for years—often resulting in the ANDA applicant’s abandonment of the Suitability Petition.

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FDA Dosage 59

The FDA Law Blog

FEBRUARY 2, 2025

California pharmacists are still able to provide the oral therapeutics without requiring you to visit your primary care physician through January 1, 2026. The most common drug Californians may be looking for this winter is Paxlovid.

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Packaging Documentation Compounding 59

pharmaphorum

JUNE 27, 2022

Tazverik is a first-in-class EZH2a inhibitor that was cleared by the FDA in 2020 as a third-line or later treatment for adults with relapsed or refractory follicular lymphoma (FL) whose tumours have an EZH2 mutation. Ipsen’s CVR offer includes $0.30

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Compounding FDA 110

The FDA Law Blog

DECEMBER 23, 2024

This means that, at the current moment, FDA cannot award any priority review vouchers for rare pediatric disease product applications unless it is for a drug that was designated as a drug for a rare pediatric disease not later than December 20, 2024, and such application is approved not later than September 30, 2026.

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FDA 59

The FDA Law Blog

FEBRUARY 13, 2025

Baumhardt, Principal Medical Device Regulatory Expert FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF). If FDA agrees to the PCCP, such changes can be made without a supplemental marketing submission.

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FDA Documentation Labelling Method Validation 71

pharmaphorum

OCTOBER 17, 2022

The FDA is planning to take an additional three months to review Biogen’s experimental therapy for amyotrophic lateral sclerosis (ALS), setting back its decision date from January to April. There was no update from Biogen on whether the FDA will require an advisory committee meeting to review the data with the drug.

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FDA 52

pharmaphorum

OCTOBER 1, 2020

Shares in US biotech CTI BioPharma have shot up after the FDA agreed to an accelerated review early next year of its lead drug pacritinib for low blood platelets (thrombocytopenia) caused by myelofibrosis. The post CTI wins over FDA to claim early review of myelofibrosis drug appeared first on. Jakafi had sales of more than $1.1

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FDA Packaging Labelling 52

pharmaphorum

JULY 8, 2021

The FDA has started a priority review of AstraZeneca and Amgen’s severe asthma antibody tezepelumab, setting a date for a decision in the first quarter of 2022. Tezepelumab was awarded a breakthrough designation for non-eosinophilic asthma by the FDA in 2018. Results from that programme are due in 2023.

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FDA Labelling 52

European Pharmaceutical Review

DECEMBER 22, 2023

Currently under review by the US Food and Drug Administration (FDA), KarXT is expected to launch in the US in late 2024. Registrational clinical trials are currently underway evaluating KarXT for the treatment of Alzheimer’s disease psychosis, with data expected in 2026.

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FDA 98

pharmaphorum

SEPTEMBER 23, 2022

Chances of FDA approval for Spectrum Pharma’s lung cancer candidate poziotinib and Oncopeptides’ Pepaxto for multiple myeloma have taken a dive, after the regulator’s expert advisors voted that the drugs were not ready to reach the market. Shares in the company were down 27% in after-hours trading.

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FDA Documentation 52

pharmaphorum

AUGUST 5, 2022

Sintilimab is partnered outside China with Eli Lily, but plans to bring the drug to the US market as a lower-cost rival to current PD-1/PD-L1 drugs were knocked back earlier this year when the FDA declined to approve it on data generated exclusively from Chinese studies.

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FDA 104

pharmaphorum

DECEMBER 22, 2021

The Japanese regulator looks like it could follow the European Commission and reject approval of Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm, leaving the FDA an outlier in its stance on the drug. Biogen is due to start a confirmatory trial of the drug next year, but it isn’t due to generate results until 2026.

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FDA 98

pharmaphorum

JUNE 8, 2022

Analysts at Evaluate are predicting mosunetuzumab could make more than $500 million in sales in 2026, although other predictions go as high as $1 billion. The approval, meanwhile, raises expectations of a positive outcome from the FDA as it reviews the drug for the US market.

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Chemotherapy FDA 105

Pharmaceutical Technology

JANUARY 31, 2023

FDA director Robert Califf gave his prognosis for the pharma industry at this year’s JP Morgan Healthcare Conference in San Francisco over January 9–12. This “skinny” bill passed just in time to continue funding the FDA, with few of the planned amendments. billion in funding, a $226 million increase on the previous year.

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FDA 52

The FDA Law Blog

MARCH 5, 2024

AstraZeneca also claimed that CMS’s revised guidance on the Negotiation Program for Price Applicability Year 2026 (“Guidance”) interpreted the IRA in two very faulty ways, which violated the Administrative Procedure Act (APA) and harmed and will continue to harm the company. The court found numerous flaws with this argument.

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Dosage 64

The Checkup by Singlecare

AUGUST 1, 2024

It is an antidepressant approved by the Food and Drug Administration (FDA) to treat major depressive disorder in adults. holds the patent for Trintellix, which is expected to expire in 2026, when a generic version may become available. Trintellix is a brand-name prescription drug containing the active ingredient vortioxetine.

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Insurance Mail-Order Pharmacies Insurance Coverage FDA 98

pharmaphorum

AUGUST 27, 2020

The FDA backed Blenrep for the same indication three weeks ago, despite some reservations about eye toxicity, which set the drug on course for what some analysts think could be revenues of around $1.5 billion in 2026. Among a crowded field, GSK has now won the race to bring an anti-BCMA drug to market in both Europe and the US.

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FDA Labelling 64

Pharmaceutical Technology

MARCH 10, 2023

Work on the new biologics production plant is expected to commence this year, and complete operations are scheduled to begin in late 2026. Last month, Sandoz announced that the US Food and Drug Administration (FDA) accepted its biologics license application (BLA) for its proposed biosimilar denosumab.

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FDA 52

pharmaphorum

FEBRUARY 4, 2022

billion in 2019, and is also developing the drug for paroxysmal nocturnal haemoglobinuria (PNH), another of Soliris and Ultomiris’ FDA-approved indications. UCB acquired rights to the drug when it bought US biotech Ra Pharma in a deal worth around $2.1

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FDA 52