Parents and clinicians are urged to review usage of certain health products for young children after federal authorities ...

The agency will no longer require studies comparing copycat biologics to their branded counterparts, which could help ...

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The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative ...

The US Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

A new antimicrobial generic drug was approved by officials with the FDA for the treatment of canine skin infections: ...

Investor Frenzy Pushes Subscription Over 2x Despite Valuation Concerns Retail Investors Fuel Early Buzz as Groww IPO Sees 57% Subscription on Day 1 Democrats Push Back on GOP Claims That Biden ...

Q3 2025 Management View CEO A. Kazimi announced a new strategic agreement: "We've entered into arrangements with RedHill ...

The U.S. Food and Drug Administration (FDA) has approved two new biosimilars as reference products for Prolia (denosumab) and XGEVA® (denosumab): Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo ...

The FDA has announced new rules for the approval of biosimilar drug products that could reduce 5- to 8-year timelines by half.

Alvotech, for its part, has run into repeated issues with the FDA at its Icelandic drug plant. Since the company’s biosimilar accord with Teva began, problems at the Reykjavik facility have led to two ...

A long-running confirmatory trial of two of Sarepta Therapeutics’ Duchenne muscular dystrophy drugs has missed its main goal.