Tag:
FDA approval
Latest Headlines
Latest Headlines
Vivus gets ED drug approval, spurring fresh talk of a deal
Vivus has won its first drug approval. The FDA issued word this afternoon that it had stamped its OK on Stendra (avanafil), an erectile dysfunction treatment designed to spur a quicker response for men.
New plant pushes Ranbaxy Lipitor production to global lead
Getting FDA approval of a new plant in India meant Ranbaxy was able to push out enough generic Lipitor in March to take the top spot in production of the drug.
Sanofi colorectal cancer contender Zaltrap suffers a PhIII trial setback
Sanofi and Regeneron's opened their update on the cancer drug Zaltrap (aflibercept) on a sweet note: The FDA has granted a priority review of their NDA for colorectal cancer.
Allergan asks FDA for lucrative new Botox indication
Allergan has asked U.S. and European regulators to approve Botox to treat patients with garden-variety overactive bladder, citing two Phase III trials.
UPDATED: FDA rejects Chelsea's Northera, demands additional study data
After the markets closed on Wednesday, Chelsea Therapeutics ($CHTP) put out the word that the FDA had rejected Northera.
GlaxoSmithKline undeterred by spotty results for Relovair
GlaxoSmithKline ( $GSK ) is pushing ahead with its plan to submit Relovair to regulators for approval this year.
New drug for rare leukemia wins FDA panel vote with limited data
Talon Therapeutics ($TLON) took one more tentative step closer to a possible FDA approval of its cancer drug Marqibo yesterday, winning a 7-to-4 vote among a group of the agency's oncology advisers.
FDA panel backs GSK's Votrient for soft-tissue sarcoma
Good news came for GlaxoSmithKline ( $GSK ) Tuesday after the FDA's Oncologic Drugs Advisory Committee voted 11 to 2 in favor of approving Votrient to treat patients with advanced soft tissue sarcoma who have received prior chemotherapy. The FDA approved Votrient in 2009 to treat advanced renal cell carcinoma.
Discovery Labs shares rocket up on long-awaited FDA approval
For Discovery Laboratories, the fifth try proved the charm. FDA regulators have finally stamped an approval on Surfaxin as a guard against respiratory distress syndrome in infants after four rejections spread out over an 8-year regulatory odyssey.
AstraZeneca's FluMist Quadrivalent to hit U.S. market
The FDA has approved AstraZeneca's ( $AZN ) nasal FluMist Quadrivalent flu vaccine for use in people ages 2 to 49. Made at AstraZeneca's MedImmune unit, FluMist Quadrivalent contains two...
