The booster vaccine, Gemcovac-OM works against the Omicron variant of SARS-CoV-2 and has received emergency use authorization (EUA) from the regulatory authority
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The EIR was issued post the last inspection of the facility conducted from March 6 to March 10, 2023. The inspection closed with the facility receiving an inspection classification of "No Action Indicated" (NAI)
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On Tuesday, Zydus Lifesciences in an exchange filing revealed that the group’s injectables manufacturing facility at Zydus Biotech Park in Changodar, Ahmedabad, underwent USFDA inspection from 05 June to 13 June 2023 with the cGMP inspection concluded with nil observations
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On Wednesday, the stock price of IPCA laboratories was down by 2.17 per cent to Rs 718.90 as of 10:52 IST on account of an inspection done by USFDA on an API manufacturing unit of the company in Madhya Pradesh
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Biogen's shares rose 2 per cent on Monday as a unanimous backing of its Alzheimer's drug by the U.S. health regulator's advisers strengthened the case for a traditional approval with no major new safety warnings
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Caplin Steriles, a Subsidiary company of Caplin Point Laboratories has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Cisatracurium Besylate Injection, a generic therapeutic equivalent version of, NIMBEX injection of AbbVie Inc
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Indoco Remedies has received EU GMP certification from the competent health authority of Germany for its manufacturing site situated in Baddi of the district, Solan. The agency conducted an inspection at Indoco’s manufacturing facility for oral dosage form (Baddi -III), from May 22 to May 25, 2023, the company said in an exchange filing on Friday
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The lawsuits add to a web of patent disputes between biotech companies over technology used in the coronavirus shots, including a case brought last year in Massachusetts by Moderna against Pfizer and its partner BioNTech.
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