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Category: Regulations


FDA, Regulations

Merck claims another adjuvant okay from FDA for Keytruda

December 6, 2021

Via: Pharmaphorum

The US regulator has approved Keytruda (pembrolizumab) as a treatment for melanoma patents aged 12 and over with stage 2B, 2C and 3 tumours to prevent the recurrence of the cancer after the surgical removal. Moving checkpoint inhibitors further up […]


FDA, Regulations

ImmunoGen lines up FDA filing as antibody-drug conjugate shrinks tumors in pivotal trial

November 30, 2021

Via: FierceBiotech

After toiling for 40 years, ImmunoGen can now see the potential approval of its first wholly owned oncology drug on the horizon. The biotech is preparing to submit mirvetuximab soravtansine for approval after showing the antibody-drug conjugate (ADC) shrank ovarian […]


FDA, Regulations

FDA approves new imaging drug to identify ovarian cancer lesions

November 30, 2021

Via: European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Cytalux (pafolacianine), an imaging drug intended to assist surgeons in identifying ovarian cancer lesions. The drug is designed to improve the ability to locate additional ovarian cancerous tissue that is normally […]


FDA, News, Regulations

FDA sets Sept review date for BMS’ psoriasis drug deucravacitinib

November 30, 2021

Via: Pharmaphorum

If approved, deucravacitinib would become the first tyrosine kinase 2 (TYK2) inhibitor approved for the treatment of any disease, said BMS, which is hoping to position the new drug as the treatment of choice for people with moderate to severe […]


FDA, Regulations

US FDA expands COVID-19 booster jabs to all adults

November 23, 2021

Via: PMLiVE

Previously, only people aged 65 and over and younger people at high risk of severe disease or frequent institutional or occupational exposure to the virus were eligible for a booster dose. Now, all adults can receive a booster shot six […]


FDA, Regulations

FDA, CDC COVID jab decisions ‘will simplify booster messaging’

November 22, 2021

Via: Pharmaphorum

The FDA cleared emergency use of the two vaccines on Friday, which was swiftly followed by a recommendation from a Centres for Disease Control and Prevention (CDC) advisory committee that was swiftly signed off by CDC director Rochelle Walensky. The […]


FDA, Industry, Regulations, Vaccines

Pfizer, Moderna score FDA nods for COVID boosters in all adults, setting up high-stakes CDC meeting

November 19, 2021

Via: FiercePharma

The race between Moderna and Pfizer to gain FDA nods for their COVID-19 vaccines as boosters in all adults has ended in a dead heat. On Friday morning, the FDA simultaneously expanded emergency use authorizations for both mRNA vaccines to […]


FDA, Regulations

FDA approves Besremi to treat rare blood disease

November 16, 2021

Via: European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells. Besremi is the first FDA-approved medication for polycythemia vera that […]


Pricing, Regulations

Democrats agree last-ditch deal to save drug pricing plans

November 4, 2021

Via: Pharmaphorum

A new stripped back proposal has won over rebel Democrats whose earlier opposition led the plan to be shelved, despite being a longstanding pillar of Democrat policy and one of Joe Biden’s campaign pledges. Notable holdouts – including Senator Kyrsten […]


FDA, Regulations

Pandemic Alters FDA Inspections and Quality Oversight

November 1, 2021

Via: Biopharm International

Over the past 18 months, FDA officials have tested and adopted a range of procedures to overcome restrictions on visiting facilities in person to evaluate pharmaceutical production and clinical testing operations. Many of these alternative compliance methods now are being […]


FDA, Regulations

FDA Approves Genentech’s Susvimo for Wet AMD

October 29, 2021

Via: Biopharm International

Genentech, a member of the Roche Group, announced on Oct. 22nd, 2021, that FDA had approved Susvimo (100 mg/mL ranibizumab injection) for the treatment of wet, or neovascular, age-related macular degeneration (AMD), a condition that can lead to rapid and […]


FDA, Regulations

FDA releases new guidance for drug and biological product data

October 25, 2021

Via: European Pharmaceutical Review

The US Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.” The 21st Century Cures Act was signed in 2016 and is […]