New Drug Application News and Research

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Tibotec Pharmaceuticals receives NDA for investigational HIV protease inhibitor

Tibotec Pharmaceuticals receives NDA for investigational HIV protease inhibitor

FDA grants priority review for Revlimid

FDA grants priority review for Revlimid

Bristol-Myers Squibb agrees to record securities litigation settlement with sweeping drug disclosure requirements announces Labaton Sucharow

Bristol-Myers Squibb agrees to record securities litigation settlement with sweeping drug disclosure requirements announces Labaton Sucharow

Mylan announces tentative approval for Rabeprazole sodium delayed-release tablets

Mylan announces tentative approval for Rabeprazole sodium delayed-release tablets

Chiron initiates Phase I/II study of an investigational cell culture-derived influenza vaccine

Chiron initiates Phase I/II study of an investigational cell culture-derived influenza vaccine

CytRx granted "Fast Track" designation for ALS drug

CytRx granted "Fast Track" designation for ALS drug

Potential new way to fight HIV

Potential new way to fight HIV

FDA approval sought for Pfizer's new cancer drug

FDA approval sought for Pfizer's new cancer drug

Genelabs drug discovery team advances compounds against the hepatitis C virus

Genelabs drug discovery team advances compounds against the hepatitis C virus

Takeda Pharmaceuticals submits NDA for a new oral diabetes medication

Takeda Pharmaceuticals submits NDA for a new oral diabetes medication

New cardiovascular drug derived from Dan Shen (Saliva miltiorrhiza)

New cardiovascular drug derived from Dan Shen (Saliva miltiorrhiza)

FDA approves treatment for diarrhea caused by Cryptosporidium infection

FDA approves treatment for diarrhea caused by Cryptosporidium infection

AstraZeneca announces U.S. labeling change to Iressa (gefitinib tablets)

AstraZeneca announces U.S. labeling change to Iressa (gefitinib tablets)

New diabetes drug has a double whammy and is a potential blockbuster

New diabetes drug has a double whammy and is a potential blockbuster

Targepeutics issued new U.S patent

Targepeutics issued new U.S patent

New drug for the treatment of premature ejaculation has great results

New drug for the treatment of premature ejaculation has great results

FDA recommends approval of the investigational anti-HIV drug tipranavir

FDA recommends approval of the investigational anti-HIV drug tipranavir

Benitec announces clinical candidate for the treatment of Hepatitis C

Benitec announces clinical candidate for the treatment of Hepatitis C

Fast Track designation for Terlipressin in type 1 hepatorenal syndrome

Fast Track designation for Terlipressin in type 1 hepatorenal syndrome

Cyclosporine inhalation solution (CyIS) significantly improves long-term survival in lung-transplant patients

Cyclosporine inhalation solution (CyIS) significantly improves long-term survival in lung-transplant patients