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The Securities and Exchange Board of India (Sebi) has requested information from several leading pharmaceutical companies regarding public disclosures that are stock price sensitive.
USFDA has requested additional corrective actions at its wholly-owned subsidiary’s manufacturing unit in Baddi, Himachal Pradesh, or else approval of any pending product applications from the facility may be withheld.
Glaxo Smith Kline (GSK) Pharmaceuticals and Akums Drugs and Pharmaceuticals (ADPL) have exchanged cease-and-desist letters in an effort to get them to stop marketing ranitidine as “Zinetac” in a dispute over alleged trademark infringement.
CDSCO declared a sample of blood pressure medication it found to be of poor quality in May to be spurious. Over 1,233 drug samples have been tested by the drug regulator over the course of the months, and 41 of those have already been flagged as being below standard.
Pfizer recently announced that its investigational Group B Streptococcus (GBS) vaccine candidate has received Breakthrough Therapy Designation from the US Food and Drug Administration for the treatment of invasive Group B Streptococcus (GBS) disease.
Lenalidomide capsules, a generic version of Bristol Myers Squibb’s (BMS) popular multiple myeloma medication Revlimid, were introduced to the US market, according to pharma major Dr Reddy’s Laboratories.
To treat people with a patent foramen ovale
(PFO), a hole in the heart that doesn’t close after
birth, who have had a stroke and are at risk of
having another, Abbott announced the launch
of its Amplatzer Talisman PFO Occlusion
System in Europe.
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