Biotech Insights - Spring 2026
Regulatory Overview: Post-Approval Changes to Marketed Drugs - The popularity of GLP-1s have brought post-approval changes to New Drug Applications (NDAs) to centerstage. Recently...
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Regulatory Overview: Post-Approval Changes to Marketed Drugs - The popularity of GLP-1s have brought post-approval changes to New Drug Applications (NDAs) to centerstage. Recently...
The popularity of GLP-1s have brought post-approval changes to New Drug Applications (NDAs) to centerstage. Recently, the FDA approved Wegovy in tablet form, offering an alternativ...
Key Takeaways: FDA will convene the Pharmacy Compounding Advisory Committee (PCAC) on July 23-24, 2026, to discuss seven peptides for potential inclusion on the 503A bulks list. A...
By Charles D. Snow & Kalie E. Richardson —
THURSDAY, April 2, 2026 — Folks with severe plaque psoriasis often have to choose between convenient pills that don’t work very well or highly effective injections that come with t...
THURSDAY, April 16, 2026 — New anti-amyloid drugs approved to treat Alzheimer’s disease have no clinically meaningful positive effects for patients, a major evidence review has co...
News Briefs - High Court Won't Hear Drug Manufacturer Price Negotiation Appeal - The Supreme Court declined to hear an appeal from six drug manufacturers that wanted the court to r...
WEDNESDAY, April 29, 2026 — The U.S. Food and Drug Administration (FDA) is moving to speed drug development and review by launching real-time clinical trials. The move could soon...
THURSDAY, April 16, 2026 — A widely used anxiety medication is being pulled from shelves due to "failed dissolution specifications," the U.S. Food and Drug Administration (FDA) sa...
FRIDAY, April 17, 2026 — The U.S. Food and Drug Administration (FDA) will soon review whether certain peptides should be allowed in customized medications made by compounding phar...
TUESDAY, April 7, 2026 — The United States is planning new tariffs on some name-brand medicines. The move could affect drug prices and how medicines are made. Officials say tariffs...
On April 16, 2026, the U.S. Food & Drug Administration (FDA) announced it will convene the Pharmacy Compounding Advisory Committee (PCAC) on July 23 and 24, 2026, to discuss pe...
A dangerous synthetic drug, referred to as Cychlorphine, has reportedly been detected in illegal drugs seized in Texas and at least 9 other states, according to the White House Off...
The FDA Cracks Down on Tavneos Anonymous (not verified) Thu, 04/30/2026 - 14:18 pharmagather item url The FDA Cracks Down on Tavneos pha...
Following the notification, Pregabalin will now be regulated under the stricter provisions of Schedule H1, instead of the existing Schedule H, under the Drugs and Cosmetics Rules,...
TUESDAY, April 21, 2026 — People prescribed gabapentinoid painkillers, such as gabapentin (Gralise, Neurontin, Gabarone, Relgaabi), gabapentin enacarbil (Horizant), or pregabalin (...
デジタル庁は25日、「マイナポータル」の「薬」画面を改善した。従来は、前月までに薬局や医療機関で受け取った薬の情報を確認できたが、リニューアルにより、直近100日以内に受け取った薬や処...
WEDNESDAY, April 15, 2026 — The U.S. Food and Drug Administration (FDA) has told Eli Lilly to study possible heart, liver and other risks tied to its new obesity drug Foundayo, ac...
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