Tag: FDA

ViiV Submitted Request to FDA and EMA for Dispersible Formulation of Dolutegravir

viiv healthcare
ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced it has made regulatory submissions to both the ...

FDA Granted Fast Track Designation for Lebrikizumab

fda
Dermira, Inc., a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic sk...

FDA Warned Alkermes over Opioid Addiction Treatment Advertising

A print advertisement of Alkermes Plc's addiction treatment, Vivitrol, is false or misleading as it omits important risk information associated with its use, the Food and Drug Administration said in a...

FDA Evaluated Brinavess as not Adequate for Approval

An FDA advisory panel on Tuesday voted 11-2 that the benefit-risk profile of Correvio Pharma's anti-arrhythmic drug Brinavess (vernakalant) was not adequate to support approval. Correvio is looking to...

FDA Recalls 25 Drugs, Supplements and Medical Devices Distributed by Basic Reset and Biogenyx

The U.S. Food and Drug Administration is alerting consumers of a recall of 25 drug, dietary supplement and medical device product lines distributed by Basic Reset and Biogenyx of Hendersonville, Tenne...

FDA Warned Two Companies for Processing and Distributing Unapproved Products

The U.S. Food and Drug Administration has warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC, of Yorba Linda, California, and their presidents and chief executive officers, Roya Panah and John W....

FDA Ordered Additional Testing of Ranitidine and Nizatidine

clinical trials
To further its investigation into the cause of the NDMA impurities found in ranitidine and nizatidine, the FDA has asked manufacturers of these products to expand their testing to include all lots...

FDA and EMA Granted Orphan Drug Designation to Zotiraciclib

The FDA and EMA have granted Orphan Drug Designation to zotiraciclib, currently the subject of two separate Phase Ib clinical trials in glioblastoma. Zotiraciclib has been granted Orphan Drug...

FDA Applied to FDA for Fostemsavir Approval

viiv healthcare
ViiV Healthcare is seeking approval from the US Food and Drug Administration (FDA) for its fostemsavir to treat HIV-1 infection. The company has completed the submission of a new drug applicati...

US Senate Committee Advanced Nomination of Stephen Hahn to Lead FDA

fda
A Senate committee advanced the nomination of Dr. Stephen Hahn, a noted oncologist and cancer researcher, to lead the Food and Drug Administration. Dr. Hahn, a chief medical executive at th...

FDA Granted Orencia Breakthrough Therapy Status

Bristol-Myers Squibb (BMS) has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its Orencia (abatacept) to prevent moderate to severe acute graft-versus-host dise...

FDA Finalized Guidance on Adaptive Clinical Trial Designs for Drugs and Biologics

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The US Food and Drug Administration (FDA) last week finalized guidance on adaptive clinical trial designs for drugs and biologics. The 33-page guidance, which finalizes a draft version released for...

FDA Accepted sBLA and Granted Priority Review for Imfinzi

astrazeneca
AstraZeneca announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for Imfinzi (durvalumab) for the treat...

FDA Warned EPH Technologies for Taking Orders for Various Unapproved New Drugs

The US Food and Drug Administration (FDA) sent a warning letter to New Mexico-based EPH Technologies for taking orders on its website for various unapproved new drugs. The unapproved drugs are mean...

Verrica Pharma NDA for VP-102 Accepted by FDA

Verrica Pharmaceuticals Inc., a medical dermatology company, announced that its New Drug Application (NDA) for VP-102 (cantharidin 0.7% Topical Solution), a proprietary topical therapy for the treatme...

FDA Approved Biocon New Facility at Bengaluru

biocon
The US Food and Drug Administration (FDA) has approved Biocon Ltd's new facility at Bengaluru for the manufacturing of pegfilgrastim biosimilar Fulphila, the company said in a release. Approval for...