Pharmaceutical Technology

SEPTEMBER 21, 2023

The US FDA has accepted Takeda’s NDA resubmission for TAK-721 for the short-term treatment of eosinophilic esophagitis (EoE), for review.

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FDA 111

STAT

SEPTEMBER 20, 2023

ARS Pharma had high hopes that the FDA on Tuesday would approve its flagship product, a needle-free treatment for adults and children with severe allergic reactions. But instead, the drugmaker was set back with the agency requesting an additional study.

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FDA 123

Drug Topics

APRIL 24, 2023

The FDA is hoping these warnings are a positive step in what will be an extremely long process of ending opioid related deaths.

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Fierce Pharma

SEPTEMBER 11, 2023

The FDA has approved Pfizer and Moderna’s separate vaccine formulations that target current variants of the disease. Out with the old and in with the new: Monday, the U.S. | Each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old.

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The Guardian - Pharmaceutical Industry

SEPTEMBER 12, 2023

Advisory panel reviewed studies of phenylephrine, an active ingredient in Benadryl, Mucinex, Sudafed PE and Tylenol A common decongestant ingredient of numerous popular over-the-counter cold and flu remedies does not work, the Food and Drug Administration (FDA) concluded on Tuesday. Continue reading.

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FDA 107

STAT

SEPTEMBER 21, 2023

Can the FDA be too flexible? We also discuss a momentous upcoming meeting in which FDA will consider the thorny case of a potential medicine for ALS whose supporting evidence has polarized patients and physicians. How do you test a mechanical womb? And who decides what’s good enough for patients in need? Read the rest…

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FDA 82

Fierce Pharma

SEPTEMBER 13, 2023

But on Tuesday, an FDA advisory committee agreed by a 16-0 vote that the ingredient does not work. For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. |

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FDA 122

Pharmaceutical Technology

SEPTEMBER 18, 2023

The FDA released a draft guidance giving advice on the correct labelling of biosimilar and interchangeable biosimilar products.

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Fierce Pharma

SEPTEMBER 20, 2023

Positive FDA advisory committee votes aren’t always a blueprint for approval. Positive FDA advisory committee votes aren’t always a blueprint for approval. ARS Pharmaceuticals learned that lesson the hard way, as the FDA issued a surprise rejection of its anaphylaxis nasal spray Neffy.

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FDA 88

Fierce Pharma

SEPTEMBER 20, 2023

UCB had previously expected an FDA decision during the first half of the year after suffering a prior rejection on its medicine. After a manufacturing-related complete response letter held up the U.S. | But now the company warned a decision will likely be delayed past the third quarter.

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FDA 107

The Checkup by Singlecare

JULY 14, 2023

Food and Drug Administration (FDA) approved the first over-the-counter birth control pill , Opill (norgestrel), on July 13. According to the FDA, there are 3 million unintended pregnancies in the U.S. Today’s FDA decision is a historic moment for health equity, sexual health, and reproductive rights. … Who can take Opill?

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Fierce Pharma

AUGUST 30, 2023

Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases. Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases.

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FDA 121

STAT

SEPTEMBER 12, 2023

After years of deliberation, the FDA has proposed giving patients a simple one-pager for every prescription drug with the information needed for safe and effective use. Patients often ask two questions about every medical treatment: Will it help me? Will it hurt me? The Food and Drug Administration knows many of the answers.

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FDA Packaging 129

European Pharmaceutical Review

AUGUST 10, 2023

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. Eight FDA warning letters were handed to European companies in 2018. Edge Biologicals Inc.,

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FDA Packaging 80

Fierce Pharma

AUGUST 30, 2023

And the FDA's approval of several generics comes amid a U.S. After 16 years on the market, Takeda's blockbuster attention-deficit/hyperactivity disorder (ADHD) med Vyvanse has finally reached its patent cliff. | After 16 years on the market, Takeda's blockbuster ADHD med Vyvanse has finally reached its patent cliff.

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FDA 137

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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FDA Pharmaceutical Companies Pharmaceutical Companies Labelling 97

pharmaphorum

SEPTEMBER 18, 2023

GSK gets wide FDA approval for myelofibrosis drug Phil.Taylor Mon, 18/09/2023 - 07:31 Bookmark this

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FDA 105

The FDA Law Blog

SEPTEMBER 19, 2023

Industry has long requested input from FDA about the types of patents that can be listed in the Orange Book, and, in response, FDA asked for comments on the types of patents that should be listed. But FDA has never made an affirmative statement as to the types of patents that can be listed in the Orange Book.

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pharmaphorum

SEPTEMBER 15, 2023

FDA capacity forces delay to Iovance's cell therapy Phil.Taylor Fri, 15/09/2023 - 10:57 Bookmark this

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FDA 111

Pharmacy Times

AUGUST 7, 2023

However, the FDA said an application for zuranolone to treat major depressive disorder did not provide substantial evidence of efficacy.

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FDA 123

Pharmaceutical Technology

SEPTEMBER 12, 2023

The US FDA has approved Pfizer and BioNTech’s sBLA for Omicron XBB.1.5-adapted adapted monovalent Covid-19 vaccine, COMIRNATY 2023-2024 Formulation.

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Pharmafile

SEPTEMBER 14, 2023

Madrigal Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for resmetirom for the treatment of adult patients with nonalcoholic steatohepatitis (NASH) with liver fibrosis.

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FDA 59

STAT

SEPTEMBER 14, 2023

We also discuss the latest news in the life sciences, including an IPO implosion, a debate at the FDA, and the ups and downs of a career in biotech. Our colleague Helen Branswell joins us to discuss the state of the Covid-19 pandemic heading into the fall and the rollout of boosters shots aimed at the latest viral variants.

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Fierce Pharma

JUNE 9, 2023

After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing.

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FDA 144

STAT

AUGUST 22, 2023

  FDA greenlights device to combat bladder issues Read the rest… You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.    Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday. 

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STAT

JUNE 9, 2023

The group voted 6-0 that an 1,800-patient study of Leqembi confirmed its benefits for patients in the early stages of Alzheimer’s, recommending the FDA widen the drug’s limited approval. The agency, which is not required to follow the suggestions of its advisers, is expected to make a final decision on Leqembi by July 6.

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Fierce Pharma

SEPTEMBER 11, 2023

Ahead of an important advisory committee meeting, the FDA has raised serious questions about Alnylam’s bid to expand Onpattro into a much larger group of patients with transthyretin amyloidosis (AT | The FDA has raised questions about Alnylam's Onpattro as the company seeks to expand the drug into a much larger group of patients with transthyretin (..)

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FDA 112

pharmaphorum

SEPTEMBER 6, 2023

FDA starts review of Roche's PNH drug crovalimab Phil.Taylor Wed, 06/09/2023 - 09:26 Bookmark this

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FDA 116

pharmaphorum

SEPTEMBER 14, 2023

Alnylam's Onpattro clears FDA vote for ATTR-cardiomyopathy Phil.Taylor Thu, 14/09/2023 - 09:01 Bookmark this

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FDA 99

Fierce Pharma

SEPTEMBER 6, 2023

The FDA handed the company a complete response letter for its Ultomiris application in neuromyelitis optica spectrum disorder, a rare autoimmune disease affecting the central nervous system. AstraZeneca’s Ultomiris expansion plan has hit a snag in the U.S. |

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FDA 106

Pharmacy Times

AUGUST 16, 2023

Melphalan/hepatic delivery system (Hepzato Kit; Delcath Systems Inc) is currently the only liver-directed therapy approved by the FDA for the treatment of netastatic uveal melanoma and percutaneous hepatic perfusion.

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FDA 122

Pharmafile

SEPTEMBER 13, 2023

LimFlow SA has announced that the US Food and Drug Administration (FDA) has approved its LimFlow System for the treatment of patients with chronic limb-threatening ischemia (CLTI) who have no other suitable endovascular or surgical treatment options and are otherwise facing major amputation.

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FDA 59

pharmaphorum

SEPTEMBER 6, 2023

FDA blocks new use for AstraZeneca's Ultomiris Phil.Taylor Wed, 06/09/2023 - 10:52 Bookmark this

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FDA 105

Fierce Pharma

SEPTEMBER 7, 2023

It’s looking like Roche may not receive an on-time FDA decision for the subcutaneous version of its cancer immunotherapy Tecentriq.

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FDA 109

Fierce Pharma

SEPTEMBER 13, 2023

After Alnylam faced FDA doubts about its bid to expand RNA-silencing drug Onpattro into a rare heart disease called transthyretin amyloidosis cardiomyopathy (ATTR-CM), the company has picked up key | An FDA advisory committed voted in favor of Alnylam's bid to expand its RNA-silencing drug Onpattro into the rare heart disease called ATTR-CM.

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FDA 94

Pharmaceutical Commerce

AUGUST 30, 2023

Event’s first session aims to analyze the legislation’s implementation, as FDA enforcement is delayed until November 2024.

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FDA 105

pharmaphorum

SEPTEMBER 20, 2023

FDA rejects needle-free epinephrine from ARS Phil.Taylor Wed, 20/09/2023 - 10:00 Bookmark this

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FDA 82