41 results
8-K
EX-99
INVA
Innoviva Inc
26 Feb 09
Regulation FD Disclosure
12:00am
registry of pregnant women exposed to telavancin will also be required. The letter indicates that telavancin, if approved, will be classified … in pregnant women with cSSSI would outweigh the risks, and 25 to 1 that a risk management strategy is needed to prevent unintended use of telavancin
8-K
EX-99
INVA
Innoviva Inc
19 Nov 08
Regulation FD Disclosure
12:00am
women with cSSSI would outweigh the risks, and 25 to 1 that a risk management strategy is needed to prevent unintended use of telavancin in pregnant … women or women of child-bearing potential. Telavancin is a novel, bactericidal, once-daily injectable investigational antibiotic discovered by Theravance
8-K
EX-99
INVA
Innoviva Inc
12 Feb 09
Results of Operations and Financial Condition
12:00am
situations in which the benefits of telavancin use in pregnant women with cSSSI would outweigh the risks, and 25 to 1 that a risk management strategy … is needed to prevent unintended use of telavancin in pregnant women or women of child-bearing potential. Although it is not binding, the Committee's
8-K
EX-99
INVA
Innoviva Inc
21 Jun 13
Other Events
12:00am
Women of childbearing potential should have a serum pregnancy test prior to administration of VIBATIV®. Avoid use of VIBATIV® during pregnancy unless … at clinically relevant doses raise concerns about potential adverse developmental outcomes in humans. If not already pregnant, women of childbearing potential
8-K
EX-99
INVA
Innoviva Inc
29 Nov 12
Regulation FD Disclosure
12:00am
(AT) and clinically evaluable (CE) patient populations was achieved.
VIBATIV® Important Safety Information (US)
Fetal Risk
Women of childbearing potential should … about potential adverse developmental outcomes in humans. If not already pregnant, women of childbearing potential should use effective contraception
8-K
EX-99
vnjg4j5a8lms5tj
20 May 11
Other Events
12:00am
8-K
EX-99
25y9w1kmw4dyj6clhzl0
15 Sep 11
Other Events
12:00am
8-K
EX-99
x01pfnq 2ou46srq1wi
27 Nov 09
Other Events
12:00am
8-K
EX-99
ol2yx 3sw4i28i
14 Sep 09
Other Events
12:00am
8-K
EX-99
03vk wph5
28 Jan 10
Other Events
12:00am
8-K
EX-99.1
k3v irxqi
14 Jan 10
Regulation FD Disclosure
12:00am
8-K
EX-99
ojlx50jvrsf6d319r
21 Apr 10
Results of Operations and Financial Condition
12:00am
8-K
EX-99
0v9g2 5855nb
27 Oct 09
Results of Operations and Financial Condition
12:00am
8-K
EX-99.1
zteoobysmymzgnq
9 Apr 14
Regulation FD Disclosure
12:00am
8-K
EX-99
ih9pvj50pn
11 Feb 10
Results of Operations and Financial Condition
12:00am
8-K
EX-99.1
sxqgrvkeko8xc
12 Jan 11
Regulation FD Disclosure
12:00am
8-K
EX-99
n47dp3fqo0gv0
27 Oct 11
Results of Operations and Financial Condition
12:00am
8-K
EX-99
gfxpngf4rc72y
12 Feb 13
Results of Operations and Financial Condition
12:00am
8-K
EX-99
k1yi9ltcpxvamo36aupm
25 Apr 13
Results of Operations and Financial Condition
12:00am
8-K
EX-99.1
0n7b8mheqqddne69i51
27 Oct 08
Other Events
12:00am