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Catalyst's long-delayed Firdapse snags FDA nod, but pricing questions loom fiercepharma
December 05, 2018
It took a breakthrough designation, orphan drug status, an embarrassing up-front rejection letter and some extra trials, but Catalyst Pharmaceuticals has finally crossed the finish line with Firdapse.
Seattle Genetics CEO goes inside its lightning-quick Adcetris nod, courtesy of FDA's real-time pilot fiercepharma
December 05, 2018
Seattle Genetics CEO Clay Siegall remembers reading about the first FDA approvals under the agency’s new Real Time Oncology Review pilot, secured 24 and 28 days after filing.
Seattle Genetics CEO goes inside its lightning-quick Adcetris nod, courtesy of FDA's real-time pilot fiercepharma
December 05, 2018
SAN DIEGO—Seattle Genetics CEO Clay Siegall remembers reading about the first FDA approvals under the agency’s new Real Time Oncology Review pilot, secured 24 and 28 days after filing.
Ocular Therapeutix crosses finish line with eye treatment after running down production problems fiercepharma
December 05, 2018
After twice being sidelined by manufacturing-related CRLs, Ocular Therapeutix got FDA approval on Monday for its first eye drug.
Delays in drug approval cause more problems for Teva pharmaceutical-business
February 12, 2018
Teva has announced that it might encounter delays in the approval of a highly-anticipated migraine drug, causing a further slump in its share prices.
Opportunity or challenge? Favorable policies promote the increase of drug approval(2) en-cphi.cn
October 19, 2017
China has been highly regarding medical reform in recent years, which is a challenge and development opportunity for the pharmaceutical community.
Drug approval harmonisation shows savings potential europeanpharmaceuticalreview
August 15, 2017
Researchers have compared the regulatory authorities responsible for approving drugs and medical products to verify their effectiveness and safety…
Samsung Bioepis Obtains First Drug Approval in the U.S. contractpharma
April 25, 2017
FDA approves biosimilar Renflexis across all eligible indications
Analysis of New Drug Approval of FDA in 2017 Q1: Drugs Approved in the 3 Months were Nearly Half of en-cphi.cn
April 14, 2017
2017 is a year worth expecting, with the innovative drug development nonstop.
Space of Me-too Pharmaceutical Products to Choose the Easy Way Out to be Compressed in China en-cphi.cn
April 07, 2017
For a long time, it generally takes 3-5 years or even longer for new drugs of transnational companies from being approved to be marketed overseas to being marketed in China.

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