FDA
A year of significant policy change at the FDA brought momentum and scrutiny into the new year. As 2026 gets underway, biopharma companies are responding to sweeping vaccine changes while concerns surface about the politicization of the agency.
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The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more forthcoming about the details of agency decisions in their own disclosures, according to biopharma and regulatory analysts.
The upcoming FDA decision for Replimune’s advanced melanoma drug could be a litmus test for the agency’s future regulatory decision-making, analysts say, with implications stretching well beyond one company.
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Semglee was approved under the FDA’s 351(k) pathway, a biologics license application process. It ensures that the bio similarity is based on animal studies, clinical trials, and analytical studies.
Several biotech and biopharmaceutical companies have announced new wins with the U.S. Food and Drug Administration (FDA), with these wins ranging from Investigational New Drug (IND) application approvals for cancer treatment candidates to Fast Track Designations for investigational agents aimed toward opioid use disorder (OUD).
Merck’s Keytruda won FDA approval for the treatment of patients with high-risk, early-stage triple-negative breast cancer. The approval marked the 30th for Keytruda.
Bristol Myers Squibb (BMS) announced Friday its decision to withdraw from the U.S. market the indication for its immune checkpoint inhibitor Opdivo® (nivolumab) as monotherapy for hepatocellular carcinoma (HCC) in patients previously treated with sorafenib.
It’s a busy week for GlaxoSmithKline, although much of it is related to the upcoming demerger of its Consumer Healthcare business. Here’s a look.
The company said its Allergan eye drops met both its primary and key secondary endpoints, with patients reporting near and intermediate improvements in vision.
In a filing with the U.S. Securities and Exchange Commission earlier this month, Rosenbaum and his investment group nominated five directors to elect the CytoDyn board.
The U.S. Food and Drug Administration (FDA) had several PDUFA dates on their calendar for the last week of July, but in two cases, there were problems with the submissions ahead of time. Here’s a look.
The U.S. Food and Drug Administration (FDA) approved AbbVie’s Dalvance (dalbavancin) for acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients as young as newborns.
The FDA has now approved AstraZeneca’s convenient once-a-week glucose lowering drug for 10 to 17-year-olds with type 2 diabetes.