Less than two months after an accelerated approval from the FDA, a drug combination featuring Pfizer’s Braftovi has turned in ...
“This action and the agency’s designations to expedite the drug’s development and review underscore FDA’s commitment to approving safe and effective alternatives to opioids for pain ...
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
The drugs’ active ingredient, glatiramer acetate, has been linked to more than 80 cases of anaphylaxis worldwide since ...
Joel Stanley, the founder and former CEO of Charlotte’s Web, is leading an effort to achieve approval from the FDA for a ...
MIRAMAR, Fla. - HCW Biologics Inc. (NASDAQ: HCWB), a clinical-stage biopharmaceutical company with a market capitalization of approximately $12.4 million, announced today that it has received U.S.
provides an update on recent exchanges with the U.S. FDA (Food and Drug Administration) about the development of ADV7103 in cystinuria, and announces that it has reached an important milestone.
Karolinska Development AB (Nasdaq Stockholm: KDEV) today announces that its portfolio company Dilafor has successfully completed regulatory meetings with the U.S. Food and Drug Administration ...