pharmaphorum

APRIL 27, 2021

FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market. . Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies.

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FDA Chemotherapy Documentation 90

STAT

APRIL 30, 2024

Earlier this year, Better Therapeutics, developer of an FDA-cleared app for the treatment of type 2 diabetes shut down operations. Founded in 2011, Akili Interactive made waves in 2020 when it received Food and Drug Administration clearance for EndeavorRx , its treatment for young people with ADHD.

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Insurance FDA 114

STAT

OCTOBER 24, 2023

Damian here with news of a 2021-sized biotech round that has echoes of 2011, plus an ESMO recap and a curious stock move. Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Good morning, everyone. Read the rest…

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FDA 104

STAT

OCTOBER 23, 2024

Compounding pharmacies are typically allowed to make copies of drugs that are deemed to be in shortage by the FDA, which semaglutide has been for over two years. The FDA still has to make a decision on whether to officially place semaglutide on the lists. regulators in 2011. appeals court ruling in its favor , Reuters writes.

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Compounding Compounding Pharmacies FDA Documentation 102

pharmaphorum

JULY 6, 2022

The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? A new cross-sectional study has found that the FDA green lit 95% of the 89 new oncology therapies approved between 2010 and 2019 before the EMA, with the Europeans trailing the Americans by a median of 241 days.

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FDA 98

pharmaphorum

FEBRUARY 23, 2021

The FDA is to begin a fast review of Incyte’s Jakafi (ruxolitinib) for patients with chronic graft-versus-host disease (GVHD), which cannot be treated with steroids. The post FDA to quickly review Incyte’s Jakafi in chronic GVHD appeared first on.

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FDA Labelling 66

Pharmaceutical Commerce

NOVEMBER 13, 2023

Exparel was initially approved in 2011 for single-dose infiltration into a surgical site.

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FDA 52

The FDA Law Blog

AUGUST 12, 2024

As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” FDA’s PTE regulations at 21 C.F.R. FDA guidance has been clear that that point for rolling submissions is when the last component has been submitted.

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FDA 59

The FDA Law Blog

FEBRUARY 28, 2024

This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. Without commenting on the merits of the decision, it is an interesting window into how FDA may use these new procedures in practice. Tobolowsky & Michelle L.

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FDA Documentation Labelling 59

European Pharmaceutical Review

OCTOBER 17, 2024

This decision was granted a couple of weeks following approval by the US and Drug Administration (FDA). World Allergy Organization (WAO) White Book on Allergy 2011-2012: Executive Summary. What are the main advantages of EURneffy over similar treatments? Hand (N Y). 2007; 2(1):5-11. Derived from IQVIA Claims Data, 2023.

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FDA 121

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?

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FDA Documentation Pharmaceutical Companies Pharmaceutical Companies 103

pharmaphorum

NOVEMBER 17, 2020

Shareholders in Celgene received a contingent value right (CVR) at the time of the company’s $74 billion merger with BMS last year, which pay out $9 each if the FDA approves three medicines before certain deadlines. The post Fresh doubts over BMS’ merger payout as FDA delays key drug review appeared first on.

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FDA 52

The Checkup by Singlecare

DECEMBER 5, 2023

Food and Drug Administration (FDA) recently approved Zepbound , a new version of Mounjaro, for weight loss. It can help trigger a feeling of fullness after a meal and slow the digestion process. Tirzepatide is manufactured under the brand name Mounjaro for Type 2 diabetes treatment. appeared first on The Checkup.

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Insurance Prescription Filling FDA Dosage 105

pharmaphorum

JANUARY 12, 2022

It’s the end of the road for the South San Francisco-based company, which became part of the Daiichi Sankyo in a $935 million deal in 2011 and since then has contributed two approved cancer therapies – Zelboraf (vemurafenib) for melanoma and Turalio (pexidartinib) for tenosynovial giant cell tumours.

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FDA 98

The FDA Law Blog

JULY 24, 2023

After suing each other in patent litigation and Avadel’s suit against FDA challenging the Agency’s authority to compel patent certifications, it’s Jazz’s turn to sue FDA. Approximately six weeks after FDA approved Lumryz and issued its clinical superiority decision , Jazz filed a Complaint against FDA in the District Court of D.C.

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FDA Patient Care 52

European Pharmaceutical Review

SEPTEMBER 22, 2022

The application of Bayesian methodology has been recognised by the US Food and Drug Administration (FDA) as useful in early phase clinical trials involving paediatric populations. FDA presentation. 2011 May; 46(3): 399–424. FDA Rare Diseases: Natural History Studies for Drug Development Guidance for Industry.

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Pharmaceutical Companies Pharmaceutical Companies FDA Documentation 122

Birth Control Pharmacist

APRIL 18, 2023

In June 2022, the AMA urged the FDA to approve an OTC contraceptive method with no age restriction. In order for a drug to be approved for OTC use by the FDA, certain criteria must first be met. The next step is having a pharmaceutical company manufacture a product that can be FDA-approved for OTC use. What is Opill?

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FDA Pharmaceutical Companies Pharmaceutical Companies 52

The FDA Law Blog

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

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Labelling FDA 45

pharmaphorum

MARCH 18, 2022

PopCap was also acquired by EA in 2011, and David stayed on at the company to oversee the launch of hit titles including Plants vs Zombies 2 and Plants vs Zombies Garden Warfare. Akili’s first product – EndeavorRx for treating attention deficit hyperactivity disorder (ADHD) – was the first prescription gaming app approved by the FDA.

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FDA 98

The People's Pharmacy

APRIL 13, 2023

FDA Considers New Warnings on LASIK Eye Surgery: The FDA first approved the laser devices for this procedure in 1999. By 2011, Dr. Waxler had changed his mind about the safety of the procedure. Consequently, he petitioned the FDA to issue a Public Health Advisory regarding LASIK-related injuries.

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FDA Communication 81

Pharmaceutical Technology

NOVEMBER 14, 2022

In August 2021, Saphnelo, a type 1 interferon receptor antibody, became the first lupus treatment to be approved since GSK’s Benlyta (belimumab) won a regulatory nod in 2011. The] main the main issue is that there aren't that many sites in the US where MSCs can be produced in sufficient quantities in FDA-certified labs,” says Gilkeson.

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Immunization FDA 144

pharmaphorum

MARCH 21, 2022

Bristol-Myers Squibb has won FDA approval for the first LAG-3 inhibitor drug ahead of its rivals in cancer immunotherapy including Merck & Co. The post BMS gets FDA OK for first LAG-3 checkpoint inhibitor appeared first on. months, versus 4.6 months for Opdivo alone.

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FDA Immunization 52

The FDA Law Blog

MAY 27, 2024

On the premarket side, in addition to the preparation of pre-submission and submission materials for FDA, Jennifer assists clients in responding to inquiries from FDA during the review process and participating in meetings with clients to address FDA concerns. Ellison, Managing Director at HPM.

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FDA 59

pharmaphorum

APRIL 26, 2022

PubMed cites 1,822 pieces of research relating to the microbiome in 2011, which grew to 25,153 published in 2021. The treatment has been granted US FDA breakthrough therapy designation and orphan drug designation, and has also completed a phase 3 clinical study. difficile infection (CDI).

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Immunization FDA 115

The FDA Law Blog

SEPTEMBER 11, 2023

Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R.

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Documentation FDA 64

The Checkup by Singlecare

APRIL 18, 2025

In fact, its kind of a jack-of-all-trades drug, approved by the Food and Drug Administration (FDA) to treat epilepsy, postherpetic neuralgia, and restless leg syndrome. Its also prescribed off-label for other types of nerve pain, diabetic neuropathy, mood disorders, and alcohol use disorder.

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Adverse Reactions Controlled Substances Labelling FDA 52

The Checkup by Singlecare

MAY 27, 2025

Rivaroxaban, the active ingredient in Xarelto, demonstrated its efficacy and safety for preventing stroke in Afib in the landmark 2011 ROCKET AF study. The FDA label for Xarelto specifically highlights the risk of bleeding and warns of dangerous spinal hematoma development after spinal anesthesia or puncture. Is Xarelto right for you?

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Labelling FDA 52

pharmaphorum

JANUARY 25, 2023

BMS’ lawsuit claims that Imjudo (tremelimumab) infringes two patents covering its own CTLA4 drug Yervoy (ipilimumab), which has been on the market since 2011 and is a key component of combination therapies for cancer with BMS’ PD-1 inhibitor Opdivo (nivolumab).

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Chemotherapy FDA 52

pharmaphorum

MARCH 9, 2022

US House Energy & Commerce Committee Chair Frank Pallone (D-NJ) has introduced a new bill to enhance the Food and Drug Administration’s (FDA) authority to ensure products that receive accelerated approval are providing a clinical benefit to patients.

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FDA 52

The FDA Law Blog

NOVEMBER 9, 2023

Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. Prior notice” informs FDA about the products it can expect to be offered for import into the country. By Sophia R. Gaulkin & Riëtte van Laack — On October 31, 2023, the U.S.

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FDA 52

The FDA Law Blog

JANUARY 4, 2023

As previously m entioned , sponsors can interact with FDA in the town hall by submitting questions in advance or by asking a question live during the meeting. The Agency repeatedly stated and strongly recommends sponsors engage with FDA prior to submitting the IND. Comparability.

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FDA Labelling 59

The Checkup by Singlecare

DECEMBER 1, 2023

Food and Drug Administration (FDA) certifies the Red Dye 40 as safe for human consumption. Apart from Red Dye 40, there are eight other certified color additives approved for use in food by the FDA: Blue No. The FDA has denied any link between the two for years. The controversy surrounding Red Dye 40 The U.S. 1, Blue No.

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Labelling FDA Documentation 52

The FDA Law Blog

SEPTEMBER 15, 2024

And because of that, we try to stay abreast of such things (while staying in our “FDA lane”), especially when Congress gets involved to change the law. The PREVAIL Act In short, the PREVAIL Act is intended to, among other things, reform the Inter Partes Review (“IPR”) process created by the 2011 Leahy-Smith America Invents Act.

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FDA 76

Pharma Marketing Network

MARCH 25, 2022

The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Additional concerns for the caregiver include a strain on physical and mental health. 5 While the CDC gathers information on these topics for public health planning, there are immediate needs that pharma can address. . What Can Pharma Do?

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Labelling FDA 98

The FDA Law Blog

OCTOBER 9, 2022

In 2016, DEA denied two petitions — originally filed in 2011 and 2009 — after HHS concluded that marijuana continued to meet schedule I criteria by having a high potential for abuse, no accepted medical use in the United States, and lacking an acceptable level of safety for use even under medical supervision.

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Controlled Substances 105

PharmaShots

APRIL 26, 2023

The therapy also showed a reduction in need or eligibility for SRT Ref: Businesswire | Image: Bristol Myers Squibb Related News:- BMS’ Camzyos (mavacamten) Receives the US FDA’s Approval for the Treatment of Symptomatic New York Heart Association Class II-III Obstructive HCM

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FDA 40

The Checkup by Singlecare

SEPTEMBER 11, 2024

Food and Drug Administration ( FDA ) to treat major depressive disorder (depression) in adults, and it is sometimes used off-label as an appetite stimulant. In a 2011 Cochrane review , researchers concluded mirtazapine was more likely to cause drowsiness and weight gain in comparison to other antidepressants.

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Labelling FDA 87