New Drug Application News and Research

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FDA approves Covidien's morphine sulfate oral solution for chronic pain in opioid-tolerant patients

FDA approves Covidien's morphine sulfate oral solution for chronic pain in opioid-tolerant patients

1 Aug 2011
Merck submits ridaforolimus MAA with EMA for treatment of metastatic soft-tissue, bone sarcomas

Merck submits ridaforolimus MAA with EMA for treatment of metastatic soft-tissue, bone sarcomas

1 Aug 2011
FDA approves Lannett's ANDA for Phentermine Resin Extended-Release Capsules

FDA approves Lannett's ANDA for Phentermine Resin Extended-Release Capsules

29 Jul 2011
FDA issues Refusal to File letter for Eisai's perampanel NDA to treat partial-onset seizures

FDA issues Refusal to File letter for Eisai's perampanel NDA to treat partial-onset seizures

29 Jul 2011
Yaupon seeks FDA marketing approval of mechlorethamine gel for mycosis fungoides

Yaupon seeks FDA marketing approval of mechlorethamine gel for mycosis fungoides

28 Jul 2011
Amylin, Lilly and Alkermes submit reply to FDA complete response letter for BYDUREON

Amylin, Lilly and Alkermes submit reply to FDA complete response letter for BYDUREON

28 Jul 2011
Celgene reports second quarter total revenue of $1.18 billion

Celgene reports second quarter total revenue of $1.18 billion

28 Jul 2011
POZEN reports revenue of $4.6 million for second quarter 2011

POZEN reports revenue of $4.6 million for second quarter 2011

28 Jul 2011
FDA accepts peginesatide NDA for anemia associated with CKD

FDA accepts peginesatide NDA for anemia associated with CKD

27 Jul 2011
Repligen first quarter total revenue increases 9% to $7,654,000

Repligen first quarter total revenue increases 9% to $7,654,000

27 Jul 2011
Invaron, Columbia Laboratories enter license agreement for STRIANT buccal system

Invaron, Columbia Laboratories enter license agreement for STRIANT buccal system

27 Jul 2011
Aeterna Zentaris completes AEZS-130 Phase 3 study for diagnosis of AGHD

Aeterna Zentaris completes AEZS-130 Phase 3 study for diagnosis of AGHD

27 Jul 2011
Watson second quarter net revenue increases 24% to $1.1 billion

Watson second quarter net revenue increases 24% to $1.1 billion

26 Jul 2011
Cipher net revenue decreases to $0.7 million for Q2 2011

Cipher net revenue decreases to $0.7 million for Q2 2011

26 Jul 2011
BioWa, arGEN-X sign license agreement for POTELLIGENT Technology

BioWa, arGEN-X sign license agreement for POTELLIGENT Technology

26 Jul 2011
BioSante second quarter net loss increases to $15.0 million

BioSante second quarter net loss increases to $15.0 million

26 Jul 2011
QRxPharma raises A$25 million, announces A$10.4 million Rights Issue

QRxPharma raises A$25 million, announces A$10.4 million Rights Issue

25 Jul 2011
BDSI completes BEMA Buprenorphine Phase 3 trial on chronic pain

BDSI completes BEMA Buprenorphine Phase 3 trial on chronic pain

25 Jul 2011
GlaxoSmithKline files suit against Watson over generic JALYN

GlaxoSmithKline files suit against Watson over generic JALYN

25 Jul 2011
Enrollment begins in Repligen's RG1068 pilot study to improve detection, staging of pancreatic cancer

Enrollment begins in Repligen's RG1068 pilot study to improve detection, staging of pancreatic cancer

22 Jul 2011

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