FDA Pharmaceutical Approval Process

FDA approves 1st rapid-acting insulin

According to the FDA, the medication quickly helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes.

MedPage Today · 7h

FDA OKs First Rapid-Acting Insulin Biosimilar for Diabetes

The FDA approved insulin-aspart-szjj (Merilog) as the first rapid-acting insulin biosimilar product to treat adults and children with diabetes, the agency announced Friday. Like i

Business Insider · 9h

FDA approves Sanofi biosimilar product for treatment of diabetes

The U.S. Food and Drug Administration approved Merilog as biosimilar to Novolog for the improvement of glycemic control in adults and pediatric

MarketWatch · 10h

FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes

Agency Continues Efforts to Increase Access to Insulin Treatment Options SILVER SPRING, Md., /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus.

Seeking Alpha on MSN · 8h

Sanofi gets FDA approval for NovoLog insulin biosimilar

Sanofi (NASDAQ:SNY) has received FDA approval for Merilog, a biosimilar of Novo Nordisk's (NVO) rapid-acting insulin product NovoLog, for the improvement of glycemic control in adults and children with diabetes mellitus.

Here’s What the FDA Label on Your Personal Care Products Means

Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...

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Insurer Denies Access To Drugs Granted Accelerated Approval By FDA

Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...

JD Supra1d

From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation

On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...

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Trump is unlikely to end Medicare drug price talks — here's what that means for patients and pharma

Trump could either weaken the negotiations in a way that benefits the pharmaceutical industry, or try to achieve even deeper ...

Pharmabiz1h

US FDA grants fast track designation to NKGen Biotech’s natural killer cell therapy, troculeucel to treat moderate Alzheimer’s disease

US FDA grants fast track designation to NKGen Biotech’s natural killer cell therapy, troculeucel to treat moderate Alzheimer’s disease: Santa Ana, California Saturday, Februar ...

The American Journal of Managed Care11d

OIG Report Seeks Better Oversight, Records for FDA’s Accelerated Approvals

Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...

STAT1d

The FDA must remove an unnecessary barrier to the use of clozapine for treatment-resistant schizophrenia

If the FDA follows an advisory committee’s vote, it can potentially be a transformative step in the delivery of mental health ...

Pharmaceutical Technology on MSN4d

FDA approves AbbVie’s Emblaveo for intra-abdominal infections

AbbVie has received US FDA approval for Emblaveo to be used in conjunction with metronidazole for individuals with cIAI.

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With FDA approval, Genentech turns eye implant's focus to diabetes

Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...

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