Latest News: Nifty settles below 24,600 level; broader mkt underperforms; pharma shares tumbleKarnataka issues order to merge Ayush drug dept with State FDAOrchid Pharma buyback rights to novel antibiotic; stock up 5%Natco Pharma shares dip over 2% after Rs 2,000-crore stake buy in South Africa’s Adcock Ingram10, 000 Km is just a Number for Intercontinental Tele Surgery by SSIMantraDGFT Extends Deadline on Application for Export of Pharma Grade SugarBihar Healthcare is poised to be embraced by Robotic Surgery MantraAurobindo, Cipla, Viatris to make, market long-acting injectable HIV drugPharma stocks hover near flatline even as Trump hints at new tariffs by July-endGovt revises prices of 71 medicines, including those for diabetes and infections: Check new ratesSun Pharma reaches settlement with Incyte Corporation, launches Leqselvi in U.S.Aurobindo Pharma to manufacture, supply long acting HIV treatment drugFamous Vaidyaratnam Ayurveda Clinic in Delhi is now more Accessible to PatientsEnrolment in third phase clinical trials for India’s first dengue vaccine nearly complete, says ICMRIn Gurgaon, illegal hospital busted, quack arrested in raidCustoms delivers 25 containers of seized drugs to NAFDACLicense Of Four Pharma Firms Cancelled For Illegal Drug Trade In Jammu & KashmirPharmexcil flags export disruption risk due to COPP mandate; seeks urgent reviewMaharashtra rolls back order allowing homeopaths to practise allopathy, forms review panelIndia’s Glenmark Pharma unit, AbbVie sign exclusive licensing pactVery Arty Surgery for Weight Loss by SSI Mantra, World’s FirstPills & Profits: Can India’s pharma sector handle Trump’s planned 200% tariff dose?Novartis wins approval for first malaria drug for newborns and babiesNectar to sell API, formulations & menthol biz to Ceph Lifesciences for Rs 1,290 crFlush these 17 expired medicines now. India’s top drug regulatory body issues stern warningSun Pharma confirms the stocks of ‘Levipil 500’ seized by Telangana DCA in raids is spuriousHC-ordered expert panel for weight loss drug may be set up by mid-JulyBiocon Biologics Gets UK Nod for Vevzuo, EvfraxyIndian Medical Association opposes decision to allow homeopaths to prescribe modern medicines post pharma course‘AACI Came, AACI Saw, AACI Conquered’ Indian Accreditation Domain in HealthcareTraditional medicine crucial to achieving global goals of Universal Health CoverageLupin launches Ipratropium Bromide nasal spray in USSurgical Robot MantraM, First ‘Badge of Vishwaguru’ is on Triumphal March‘Clear case of disparagement’: Delhi HC directs Patanjali to remove lines against Dabur chyawanprash in its print, TV adsAP Gets First Notified Body for Medical Device Manufacturing Facilities InspectionCBI searches premises of PCI president Montu Kumar Patel, say reportsSTF busts ₹1.20 cr cancer-drug smuggling racket in Lucknow, three heldLive worm in biscuit: Consumer court directs Rs 1.5 lakh compensation to be paid to the woman by Britannia, chemist shopCipla in talks to add new customers for its China factory, executive saysNo link between COVID-19 vaccines & sudden deaths: ICMR-AIIMS StudyDelhi High Court asks DGCI to decide on plea against licensing of weight-loss drugsMicroplastics found in brain, ovaries, and placenta: Experts warn of silent threat to vital organsSix held for exchanging bribes to give favourable report to medical collegesTelangana pharma factory blast: Death toll reaches 44, rain hampers rescue operationsAlembic Pharma surges over 12% on USFDA approval for Cancer drugSome fake dentists learned from online video, says academicPharma Firms To Face Periodic Inspection As HC Flags Effluent Risks12 dead, 13 workers rescued as reactor blast rips through pharma unit near HyderabadJB Chemicals shares tank 7% as Torrent Pharma acquires controlling stake worth Rs 25,689 croreAmrita Hospital becomes a cut above rest in Cancer Care in IndiaMedTech Zone AMTZ Puts Vizag on the Science Map of IndiaBharat Biotech, GSK to cut malaria vaccine price by more than half by 2028Sun Pharma ropes in Richard Ascroft as North America CEOTorrent Pharma shares surge 4% as JPMorgan upgrades to overweight; 18% upside seenMost Advanced Cancer Care is New Chapter @ Sir Ganga RamChemotherapy drugs made by Indian firms fail quality tests, shows studyHundreds of weight loss and diabetes jab users report pancreas problemsAct on Cataract now with Next Generation Technology to keep Blindness at bay‘Stop selling, stocking, or using’: List of drugs and cosmetic banned by KarnatakaNovo Nordisk launches blockbuster weight-loss drug Wegovy in India; Check price, dosage and other detailsAurobindo Pharma arm gets marketing authorization in UK for DyrupegSun Pharma’s European partner withdraws application for skin cancer treatment therapyGlenmark Pharma launches TEVIMBRA in IndiaIndia’s herbal and ayurvedic OTC market set to outpace global growthAnanda Pharma completes GMP manufacturing of MRX1 for clinical trialsRay of hope for HIV patients, as Hyderabad-based pharma giants secure nod for game-changing HIV drugDrug licences of 9 pharma dealers suspended in JammuSun Pharma Gets Relief on Packaging Norms for Pantoprazole-Levosulpiride FDCIn Punjab, 2 arrested with 6 kg heroin, pistol in cross-border drug bustCDSCO flags 186 drugs that fail to meet quality standardsPristyn’s Hat Trick, transcends North pushing envelop to South of VindhyasKey supplier in alprazolam smuggling racket arrested in Uttar PradeshCough Syrup Smuggling Ring Busted in Bihar’s Samastipur; Two Women Among Seven ArrestedCounterfeit cholesterol drugs worth Rs 3 lakh seized in raids at KotiPharma stock jumps after receiving approval from UK’s MHRA to sell new pharma productHIV prevention drug hailed as a ‘breakthrough’ gets FDA approvalED raids three pharma units in Baddi, NalagarhGlenmark Pharma: FDA concludes inspection at US facility, issues five observationsED conducts searches across six States in drug trafficking caseGurugram: Teen dies after ‘friendly’ blow to chest; hospital role under scannerBiocon launches Rs 4,500-crore QIP; to issue 11.6% of equity baseZydus Healthcare appoints Swati Dalal MDNatco Pharma appoints Yarramshetty Krishna Rao as Senior Vice President – Operations at MekagudaNatco API plant gets one observation from FDAPharma department refuses to name 30 doctors in bribery tangleDelhi Police busts fake cancer drugs racketSun Pharma appoints Kirti Ganorkar as the Managing DirectorPune Horror: Pharma sudent killed on way home by unlicensed driverBee might have bared Fangs like Death for Karishma Kapoor’s Ex HubbySale of scheduled drugs through online portal, IndiaMART, curbed: T.N. policeTwo die, one critical after a gas leak at Pharma CityDCA raids medical shop in Hyderabad, illegal medicines worth Rs 25K seizedPharma firm Captab Biotech banned in Punjab for 3 years following adverse drug reactionsFUJIFILM resolves to detect Breast Cancer early with Apollo HospitalsDabur reaches out to distributors as quick commerce disrupts general tradeKerala Launches MedWatch App to Verify Medicine AuthenticityPilani Public School begins in VizagRaids in Cuttack med shops over illegal sale of abortion kitsDoctors trialling ‘poo pills’ to flush out dangerous superbugsThe idea of Modern Medtech Park in Delhi germinates
Fri. Aug 1st, 2025
Latest News: Nifty settles below 24,600 level; broader mkt underperforms; pharma shares tumbleKarnataka issues order to merge Ayush drug dept with State FDAOrchid Pharma buyback rights to novel antibiotic; stock up 5%Natco Pharma shares dip over 2% after Rs 2,000-crore stake buy in South Africa’s Adcock Ingram10, 000 Km is just a Number for Intercontinental Tele Surgery by SSIMantraDGFT Extends Deadline on Application for Export of Pharma Grade SugarBihar Healthcare is poised to be embraced by Robotic Surgery MantraAurobindo, Cipla, Viatris to make, market long-acting injectable HIV drugPharma stocks hover near flatline even as Trump hints at new tariffs by July-endGovt revises prices of 71 medicines, including those for diabetes and infections: Check new ratesSun Pharma reaches settlement with Incyte Corporation, launches Leqselvi in U.S.Aurobindo Pharma to manufacture, supply long acting HIV treatment drugFamous Vaidyaratnam Ayurveda Clinic in Delhi is now more Accessible to PatientsEnrolment in third phase clinical trials for India’s first dengue vaccine nearly complete, says ICMRIn Gurgaon, illegal hospital busted, quack arrested in raidCustoms delivers 25 containers of seized drugs to NAFDACLicense Of Four Pharma Firms Cancelled For Illegal Drug Trade In Jammu & KashmirPharmexcil flags export disruption risk due to COPP mandate; seeks urgent reviewMaharashtra rolls back order allowing homeopaths to practise allopathy, forms review panelIndia’s Glenmark Pharma unit, AbbVie sign exclusive licensing pactVery Arty Surgery for Weight Loss by SSI Mantra, World’s FirstPills & Profits: Can India’s pharma sector handle Trump’s planned 200% tariff dose?Novartis wins approval for first malaria drug for newborns and babiesNectar to sell API, formulations & menthol biz to Ceph Lifesciences for Rs 1,290 crFlush these 17 expired medicines now. India’s top drug regulatory body issues stern warningSun Pharma confirms the stocks of ‘Levipil 500’ seized by Telangana DCA in raids is spuriousHC-ordered expert panel for weight loss drug may be set up by mid-JulyBiocon Biologics Gets UK Nod for Vevzuo, EvfraxyIndian Medical Association opposes decision to allow homeopaths to prescribe modern medicines post pharma course‘AACI Came, AACI Saw, AACI Conquered’ Indian Accreditation Domain in HealthcareTraditional medicine crucial to achieving global goals of Universal Health CoverageLupin launches Ipratropium Bromide nasal spray in USSurgical Robot MantraM, First ‘Badge of Vishwaguru’ is on Triumphal March‘Clear case of disparagement’: Delhi HC directs Patanjali to remove lines against Dabur chyawanprash in its print, TV adsAP Gets First Notified Body for Medical Device Manufacturing Facilities InspectionCBI searches premises of PCI president Montu Kumar Patel, say reportsSTF busts ₹1.20 cr cancer-drug smuggling racket in Lucknow, three heldLive worm in biscuit: Consumer court directs Rs 1.5 lakh compensation to be paid to the woman by Britannia, chemist shopCipla in talks to add new customers for its China factory, executive saysNo link between COVID-19 vaccines & sudden deaths: ICMR-AIIMS StudyDelhi High Court asks DGCI to decide on plea against licensing of weight-loss drugsMicroplastics found in brain, ovaries, and placenta: Experts warn of silent threat to vital organsSix held for exchanging bribes to give favourable report to medical collegesTelangana pharma factory blast: Death toll reaches 44, rain hampers rescue operationsAlembic Pharma surges over 12% on USFDA approval for Cancer drugSome fake dentists learned from online video, says academicPharma Firms To Face Periodic Inspection As HC Flags Effluent Risks12 dead, 13 workers rescued as reactor blast rips through pharma unit near HyderabadJB Chemicals shares tank 7% as Torrent Pharma acquires controlling stake worth Rs 25,689 croreAmrita Hospital becomes a cut above rest in Cancer Care in IndiaMedTech Zone AMTZ Puts Vizag on the Science Map of IndiaBharat Biotech, GSK to cut malaria vaccine price by more than half by 2028Sun Pharma ropes in Richard Ascroft as North America CEOTorrent Pharma shares surge 4% as JPMorgan upgrades to overweight; 18% upside seenMost Advanced Cancer Care is New Chapter @ Sir Ganga RamChemotherapy drugs made by Indian firms fail quality tests, shows studyHundreds of weight loss and diabetes jab users report pancreas problemsAct on Cataract now with Next Generation Technology to keep Blindness at bay‘Stop selling, stocking, or using’: List of drugs and cosmetic banned by KarnatakaNovo Nordisk launches blockbuster weight-loss drug Wegovy in India; Check price, dosage and other detailsAurobindo Pharma arm gets marketing authorization in UK for DyrupegSun Pharma’s European partner withdraws application for skin cancer treatment therapyGlenmark Pharma launches TEVIMBRA in IndiaIndia’s herbal and ayurvedic OTC market set to outpace global growthAnanda Pharma completes GMP manufacturing of MRX1 for clinical trialsRay of hope for HIV patients, as Hyderabad-based pharma giants secure nod for game-changing HIV drugDrug licences of 9 pharma dealers suspended in JammuSun Pharma Gets Relief on Packaging Norms for Pantoprazole-Levosulpiride FDCIn Punjab, 2 arrested with 6 kg heroin, pistol in cross-border drug bustCDSCO flags 186 drugs that fail to meet quality standardsPristyn’s Hat Trick, transcends North pushing envelop to South of VindhyasKey supplier in alprazolam smuggling racket arrested in Uttar PradeshCough Syrup Smuggling Ring Busted in Bihar’s Samastipur; Two Women Among Seven ArrestedCounterfeit cholesterol drugs worth Rs 3 lakh seized in raids at KotiPharma stock jumps after receiving approval from UK’s MHRA to sell new pharma productHIV prevention drug hailed as a ‘breakthrough’ gets FDA approvalED raids three pharma units in Baddi, NalagarhGlenmark Pharma: FDA concludes inspection at US facility, issues five observationsED conducts searches across six States in drug trafficking caseGurugram: Teen dies after ‘friendly’ blow to chest; hospital role under scannerBiocon launches Rs 4,500-crore QIP; to issue 11.6% of equity baseZydus Healthcare appoints Swati Dalal MDNatco Pharma appoints Yarramshetty Krishna Rao as Senior Vice President – Operations at MekagudaNatco API plant gets one observation from FDAPharma department refuses to name 30 doctors in bribery tangleDelhi Police busts fake cancer drugs racketSun Pharma appoints Kirti Ganorkar as the Managing DirectorPune Horror: Pharma sudent killed on way home by unlicensed driverBee might have bared Fangs like Death for Karishma Kapoor’s Ex HubbySale of scheduled drugs through online portal, IndiaMART, curbed: T.N. policeTwo die, one critical after a gas leak at Pharma CityDCA raids medical shop in Hyderabad, illegal medicines worth Rs 25K seizedPharma firm Captab Biotech banned in Punjab for 3 years following adverse drug reactionsFUJIFILM resolves to detect Breast Cancer early with Apollo HospitalsDabur reaches out to distributors as quick commerce disrupts general tradeKerala Launches MedWatch App to Verify Medicine AuthenticityPilani Public School begins in VizagRaids in Cuttack med shops over illegal sale of abortion kitsDoctors trialling ‘poo pills’ to flush out dangerous superbugsThe idea of Modern Medtech Park in Delhi germinates
Fri. Aug 1st, 2025

Immunomedics’ cancer treatment fails to win accelerated approval from the FDA

Immunomedics Inc said on Thursday the U.S. Food and Drug Administration declined to grant accelerated approval for its breast cancer treatment, sacituzumab.

The company said it will request a meeting with the agency and work closely with the health regulator in its effort to launch the treatment as soon as possible.

“The issues related to approvability in the CRL (complete response letter) were exclusively focused on Chemistry, Manufacturing and Control matters and no new clinical or preclinical data need to be generated,” Immunomedics Chief Executive Officer Michael Pehl said.

(Reporting by Aakash Jagadeesh Babu in Bengaluru; Editing by Sandra Maler)

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    Nifty settles below 24,600 level; broader mkt underperforms; pharma shares tumble

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