前面贴过一次,发现比较乱,这里再贴一次。希望大老们能帮着分析,也许埋着定时炸弹。
2014 FDA Drug Approval Decision Calendar
December 2013: Drug approval decisions:Gilead Sciences (GILD_)
Sofo*****uvir for hepatitis C
Dec. 6
Auxilium Pharmaceuticals (AUXL_)Xiaflex for Peyronie's disease
Dec. 6
GlaxoSmithKline (GSK_) and Theravance (THRX_)
Anoro Ellipta for COPD
Dec. 18
Amarin (AMRN_)
Vascepa for mixed dyslipidemia
Dec. 20
FDA advisory panels:
Bristol-Myers Squibb (BMY_)
Metreleptin for lipodystrophy
Dec. 11
Bristol-Myers Squibb
Dapagliflozin for Type 2 diabetes
Dec. 12
January 2014: Drug approval decisions
Biogen Idec (BIIB_)
Alprolix for hemophilia B
Jan. 3
Bristol-Myers Squibb
Dapagliflozin for Type 2 diabetes
Jan. 14
Pozen (POZN_)
PA32540 & PA8140 for heart disease
Jan. 24
Vanda Pharmaceuticals (VNDA_)
Hetlioz for non-24 sleep disorder
Jan. 31
FDA advisory panels:
Chelsea Therapeutics (CHTP_)
Northera for orthostatic hypotension
Jan. 14
Alimera Sciences (ALIM_) and pSivida (PSDV_)
Iluvien for diabetic macular edema
Jan. 27
February 2014: Drug approval decisions
Chelsea Therapeutics
Northera for orthostatic hypotension
Feb. 14
United Therapeutics (UTHR_)
Oral Remodulin for pulmonary arterial hypertension
Feb. 14
Bristol-Myers Squibb
Metreleptin for lipodystrophy
Feb. 27
Biomarin (BMRN_)
Vimizim for morquio syndrome
Feb. 28
Pharmacyclics (PCYC_) and Johnson & Johnson (JNJ_)
Imbruvica for chronic lymphocytic leukemia
Feb. 28
March 2014: Drug approval decisions
Celgene (CELG_)
Apremilast for psoriatic arthritis
March 21
April 2014: Drug approval decisions
MannKind (MNKD_)
Afrezza for Type 1 and 2 diabetes
April 15
GlaxoSmithKline (GSK)
Abiglutide for diabetes
April 15
Santarus (SNTS_)
Ruconest for hereditary angioedema
April 16
AstraZeneca (AZN_)
Epanova for hypercholesterolemia
May 5
Gilead Sciences
Idelalisib for indolent non-Hodgkin's lymphoma
May 11 (pending FDA acceptance of priority review)
Biogen Idec
Plegridy for multiple sclerosis
May 21
Durata Therapeutics (DRTX_)
Dalbavancin for skin infections
May 26
June 2014: Drug approval decisions
Omeros (OMER_)
OMS302 for ocular inflammation
June 1
Eli Lilly (LLY_)
Ramucirumab for gastric cancer
June 3
BioDelivery Sciences (BDSI_)
Bunavail for opioid addiction
June 7
Keryx Pharmaceuticals (KERX_)
Zerenex for hyperphosphatemia (kidney dialysis)
June 7
Biogen Idec
Eloctate for hemophilia A
June 12
Cubist Pharma (CBST_)
Tedizolid for skin infections
June 22 (pending FDA acceptance of priority review)
July 2014: Drug approval decisions
Anacor Pharma (ANAC_)
Tavaborole for toe fungus
July 29
September 2014: Drug approval decisions
AstraZeneca and Nektar Therapeutics (NKTR_)
Naloxegol for opioid-induced constipation
Sept. 16
October 2014: Drug approval decisions
NPS Pharmaceuticals (NPSP_)
Natpara for hypoparathyroidism
Oct. 24