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US FDA CLEARANCE
Biosimilars and innovation will drive Indian pharma's next growth phase: Vishal ManchandaIndia's pharmaceutical sector is pivoting beyond generics, with companies aggressively pursuing growth in biosimilars, nutraceuticals, and ...- Butterfly Network gets FDA clearance for AI ultrasound pregnancy toolUnlike traditional ultrasound machines that rely on expensive piezoelectric crystals, Butterfly's device uses a single silicon chip for w...
- Biomoneta earns US-FDA Class II clearance for medical air cleanersBiomoneta Research, a Bengaluru healthtech firm, has secured US FDA clearance for its Avata Rx air cleaner. This allows the company to intr...
- Biocon shares zoom 4% as Jefferies upgrades to "hold" amid positive news inflow, sets Rs 400 targetBiocon share price: This upgrade reflects a more positive outlook on the company following recent favorable news flow, particularly concern...
- DeepTek.ai secures US FDA clearance for its ground-breaking chest X-ray AI SolutionPartnered with TATA Capital and NTT DATA Japan, the leading medical imaging AI startup, DeepTek.ai, has announced that it has received clea...
- Elon Musk's Neuralink to start human trial of brain implant for paralysis patientsBillionaire entrepreneur Elon Musk's brain-chip startup Neuralink said on Tuesday that it has received approval from an independent review ...
- US FDA finds quality control, equipment issues at Alembic Pharma unitEarlier this month, the US drug regulator had issued a ‘Form 483’ to the facility of the drug company with five observations.
- Indian pharma compliance standards improving, regulatory risks here to stay: Ind-RaAs Indian pharma accounts a significant share of the US generic market, Ind-Ra said it has seen increased scrutiny of the manufacturing fac...
- 2017 onward we are getting a lot of good news in the Pharma industry: Gurudatta G G, Estima PharmaSun Pharma's Mohali plant import alert has been lifted after approximately three and a half years whereas Halol plant has recently been aud...
- Sun Pharma EPS may fall by up to 6% on USFDA notice on Halol plantThe US FDA issued the notice on Tuesday with nine inspectional observations after an onsite inspection of Sun Pharma’s Halol facility in Gu...
- USFDA’s notice may shave off 2-6% from Sun Pharma's EPS in FY18Analyst believes that Form 483 observations may delay the clearance of Halol facility and see full remediation only by first quarter of cal...
- US FDA issues seven observations on Sun Pharma's Mohali siteThe FDA said there was no password protection and noted, "Laboratory analysts have the ability to change instrument settings including date...
- Sun Pharma Halol site being inspected by US FDA: SourcesOver its recent call with investors, Sun Pharma management had maintained that the remediation exercise at the site have been completed and...
- How faster USFDA nods will help Indian generic drug makersA long spell of sluggish approvals for generic drugs in the US may be nearing an end with early signs of a rebound.
- USFDA lifts sales ban as Indian drug companies take corrective actionsCompanies which have taken corrective action after being penalised for violating FDA norms have been allowed to resume sales.
- Sun Pharma to export generic version of cancer medicine Lipidox to USShares of Sun Pharma rose 4% on Wednesday after the US drug regulator said it will import generic version of the cancer drug Lipidox.
- Opto Circuits gets USFDA nod for new patient monitoring deviceThe approval has been granted to the firm's US subsidiary, Criticare Systems Inc, by the US Food and Drug Administration.
- Lupin plants get USFDA nod; co to sell new productsDrug maker Lupin has received clearance from the US drug regulator for its plant at Mandideep in Madhya Pradesh, allowing the Mumbai-based ...
- US FDA inspects Lupin's new plant in IndoreThe US drug regulator has started inspection of Indian drugmaker Lupin’s upcoming plant at Indore last week, a person close to the developm...
- Ranbaxy asks US FDA to re-inspect Dewas facilityIndia’s largest drugmaker Ranbaxy has invited the US drug regulator to re-inspect its manufacturing plant at Dewas, raising hopes of an ear...
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