FDA approval news from FierceBiotech
NewsPharma finds promise, peril in biotech revolution
The problem with the European pharmaceuticals industry--at least in part--is Read more...
Biopharma sees tougher FDA approval process
The Wall Street Journal offers more bleak assessments from the pharma industry on their ability to win an FDA approval for a new therapy. Schering-Plough has already shuttered two programs it once Read more...
BioSante Pharma exploring its strategic alternatives
BioSante Pharmaceuticals has brought in Deutsche Bank to advise the company on its "strategic alternatives." The developer has advanced LibiGel, a topical therapy for female sexual dysfunction, into Read more...
ALSO NOTED: ASCO already churning out news; Lilly, FDA ironing out Zyprexa shot problems; and much more...
> Today marks the start of the annual ASCO. Here's a round-up of some of the news coming out of the conference. Read more...
Discovery secures $60M financing deal
Struggling Discovery Labs signed a three year, $60 million financing deal with Kingsbridge Capital, a U.K.-based investment group. Kingsbridge will provide the capital through the purchase of newly Read more...
JapanBridge pays $26M for ProStrakan patch
JapanBridge is paying $26 million in upfront and milestone payments for the rights to develop and commercialize Sancuso, a transdermal patch for the prevention of chemotherapy-induced nausea and Read more...
Early IPO at Aldagen leaves analysts wondering
A pair of analysts has taken a cautious attitude toward Aldagen's plans for an $80 million IPO. The stem-cell company has no Read more...
GSK's Garnier: FDA raised the bar for new drugs
In an interview with the Financial Times, outgoing GSK CEO Jean-Pierre Garnier shares his thought on the new, tougher FDA approval environment. While many drug developers hope the FDA's reticence Read more...
FDA picking up the pace on '08 approvals
Last year's awful record of new drug approvals by the FDA has been followed by a burst of new activity. Pharmalot reports new analysis indicating 29 Read more...
ALSO NOTED: Cambrex names new CEO; Fate Therapeutics appoints CEO and chairman; and much more...
> Shares of the UK's Allergy Therapeutics surged on the news that its experimental hay fever vaccine--Pollinex Quattro--demonstrated positive results in a crucial Phase III study, which they say Read more...
| Press ReleasesPRESS RELEASE: FDA Approves Allergan Combo Eye Drop for Glaucoma FDA Approves Allergan Combo Eye Drop for Glaucoma IRVINE, Calif. - Allergan today announced that the U.S. Food and Drug Administration has approved COMBIGAN™ (brimonidine tartrate/timolol maleate Read more... PRESS RELEASE: Theravance Asks for More Information to OK Skin Disease Drug Theravance Asks for More Information to OK Skin Disease Drug SOUTH SAN FRANCISCO, CA and DEERFIELD, IL -- Oct 22, 2007 -- Theravance and Astellas Pharma US, Inc. announced today that the U.S. Food Read more... PRESS RELEASE: Merck's Januvia Wins New Uses but Risks Outlined Merck's Januvia Wins New Uses but Risks Outlined WHITEHOUSE STATION, N.J. -- Merck & Co., Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved expanded labeling for Read more... PRESS RELEASE: FDA Approves IXEMPRA, a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Breast Cancer FDA Approves IXEMPRA, a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Breast Cancer PRINCETON, N.J., Oct. 16 -- Bristol-Myers Squibb Company announced today that the U.S. Read more... PRESS RELEASE: FDA Approves SOMA(R) (carisoprodol) 250 mg FDA Approves SOMA(R) (carisoprodol) 250 mg New Recommended Dose for Relief of Discomfort Associated with Acute, Musculoskeletal Conditions such as Back Pain SOMERSET, N.J., Sept. 17 /PRNewswire/ -- Read more... |
Get more FDA approval coverage at:
Paid Research Reports
- Leading Drug Delivery Companies and Technologies: Competitive landscape, company profiles and technological developments
- Drug Repositioning Strategies - Serendipity by design
- eHealthInsight Series: Online Patient Recruitment Strategies - Optimizing the clinical trial process
- Pricing & Reimbursement - Seven Major Markets Update
- Innovative Clinical Trial Design and Management: Trends, success stories and impact upon R&D budgets