Indoco Remedies successfully clears USFDA inspection of CRO facility AnaCipher Medical Dialogues Bureau19 Oct 2019 11:05 AM ISTCommenting on this development, Aditi Kare Panandikar, Managing Director, Indoco Remedies Limited said, “This achievement is for the fifth time in a...
Merck gets European nod for Ebola vaccine Ervebo Medical Dialogues Bureau19 Oct 2019 9:15 AM ISTThe European Medicines Agency (EMA) said its human medicines committee (CHMP) has recommended granting conditional marketing authorization in the...
Eli Lilly pancreatic cancer drug Pegilodecakin fails to meet endpoint Medical Dialogues Bureau19 Oct 2019 9:00 AM ISTNew Delhi: Eli Lilly and Company recently announced top-line results from its Phase 3 SEQUOIA trial evaluating pegilodecakin plus FOLFOX (folinic...
Glenmark Receives USFDA ANDA Approval for Abiraterone Acetate Tablets USP, 250 mg Medical Dialogues Bureau18 Oct 2019 1:40 PM ISTMUMBAI -- Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA)...
USFDA red flag to Torrent Pharma's Indrad facility Medical Dialogues Bureau18 Oct 2019 1:15 PM ISTNew Delhi: The US health regulator has red-flagged Torrent Pharmaceuticals for significant violations of current good manufacturing practice (CGMP)...
Roche bags FDA approval of Xofluza (baloxavir marboxil) for treatment of acute, uncomplicated influenza Medical Dialogues Bureau18 Oct 2019 12:28 PM ISTUS: Roche today announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for XofluzaTM...
Teva's UK arm recalls some batches of Ranitidine: Medicines watchdog Medical Dialogues Bureau18 Oct 2019 9:14 AM ISTTeva Pharmaceutical’s UK unit has recalled some batches of heartburn medicine Ranitidine, Britain’s medicines watchdog said on Thursday, making it the...
USFDA red flags Glenmark over batch failure investigations at Baddi facility Medical Dialogues Bureau17 Oct 2019 1:28 PM ISTNew Delhi: The US health regulator has red flagged Glenmark Pharmaceuticals for failing to thoroughly investigate violation of manufacturing norms and...
Sun Pharma launches Drizalma Sprinkle in US for treating neuro-psychiatric and pain disorders in patients with swallowing difficulties Medical Dialogues Bureau17 Oct 2019 1:14 PM ISTNew Delhi: Sun Pharmaceutical Industries recently announced that one of its wholly-owned subsidiaries has launched Drizalma Sprinkle™ (duloxetine...
Fujifilm Max Healthcare to jointly train doctors in breast cancer detection Medical Dialogues Bureau17 Oct 2019 9:28 AM ISTNew Delhi: Max Healthcare super speciality hospital in the National Capital on Tuesday signed a partnership with Japan's Fujifilm to train doctors in...
USFDA rebukes Torrent Pharma management of inadequacy, violations at multiple sites Farhat Nasim16 Oct 2019 6:20 PM ISTRepeated failures at multiple sites of Torrent Pharma demonstrate that executive management oversight and control over the manufacture of drugs is...
JnJ cancer drugs Darzalex, Imbruvica help it beat profit estimates for third-quarter Medical Dialogues Bureau16 Oct 2019 10:00 AM ISTJnJ is facing more than 13,000 lawsuits tied to anti-psychotic drug Risperdal as well as a range of lawsuits involving its baby powder, opioids,...
