Eton Pharma gets FDA nod on Rezipres® for treatment of hypotension in anesthesia settings

Rezipres, an ephedrine HCL (hydrochloride) injectable manufactured by Eton Pharmaceuticals, has been approved by FDA to treat clinically significant hypotension ( low blood pressure) observed in anesthetic locations. Eton’s stock trading remains suspended.
“This innovative sulfite-free formulation has been successfully sold in Europe for years, and we are excited to make it available to U.S. patients shortly,” stated Sean Brynjelsen, CEO of the company.
The investigational medication is under the evaluation of the FDA with a deadline of June 18 specified under PDUFA (Prescription Drug User Fee Act).

Topiramate oral solution, which has a deadline of August 6 set under the Prescription Drug User Fee Act, has also been submitted to get marketing authorization.

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  BioNTech Allocates $20 Million to WuXi for Two Preclinical Monoclonal Antibodies
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  Harvard researchers find improved efficacy against retinal disease in mice
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  Merck to Acquire Harpoon Therapeutics In a Deal Worth $680M
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  Novartis signs a $100 million upfront gene therapy agreement with Voyager
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  GSK returns to Hansoh and pays $185 million upfront for an additional ADC
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  Microscopic “super bots” repair neural wound model
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  Roche’s $2.7 Billion Move into the Obesity Market Acquisition of Carmot Therapeutics
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  In a late-stage trial, GSK’s blood cancer medication achieves its main objective
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  Amgen Expands Amazon Partnership to Seek Generative AI Solutions
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  Merck to Purchase Caraway Therapeutics For Over $600M
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  Setback for Bayer as Promising Anti-Clotting Drug Trials Halted
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  Karuna Therapeutics Phase 1b Trial Results Reinforce Cardiovascular Safety of Schizophrenia Treatment KarXT
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  Lilly plans to construct a $2.5 billion manufacturing facility in Germany
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  Gilead gives Arcellx $285 million to extend agreement for BCMA cell treatment
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  After success with its BabySat system, Owlet gains FDA clearance for its Dream Sock
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  Gilead to invest $100 million in Assembly Bio in return for all current and future programs
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  Roche’s Fenebrutinib Breakthrough in Multiple Sclerosis Treatment and Blood-Brain Barrier Penetration
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  After a 5-month hold FDA finally clears PepGen’s myotonic dystrophy therapy
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  Merck’s Keytruda achieves overall survival goals in early lung cancer
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  Philips Launches New Platform to Improve Health Monitoring
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  FDA Rejects Alnylam’s Expanded Approval Request for RNA Drug Patisiran in Rare Heart Condition
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  BMS to acquire Mirati in a bid to diversify oncology portfolio
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  FDA Imposes Partial Clinical Hold on Innate Pharma’s Lymphoma Program Following Safety Concerns
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  Fractyl’s GLP-1 Obesity Gene Therapy Performs Well in Weight Loss For Mice
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  FDA grants authorization to Invitae DNA test to identify cancer predisposition
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  Zeiss and Boehringer Ingelheim have formed an AI-backed alliance
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  Novartis Receives Great Reviews For Iptacon Phase 3 Performance 
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  Gilead Abruptly Halts Phase 3 Leukemia Trial Following Disappointing Data
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  Roche pays Ionis $60 million for RNA-targeting Alzheimer’s and Huntington’s disease programs
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  FDA approves RYZUMVI for pharmacologically-induced mydriasis in the U.S.
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  Takeda Wagers $580M on AcuraStem’s ALS Treatments
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  Morphic’s EMERALD-1 trial for ulcerative colitis disappoints
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  60 Degrees Pharmaceuticals Halts Tafenoquine COVID-19 Trial in Response to FDA Recommendations
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  Phase 3 trial data for Astellas’s GA drug yielded positive results
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  UCB’s Psoriasis Drug Application Faces a Further FDA Delay
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  Promising BP-NELL-PEG compound may protect astronauts from rapid bone loss in space
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  CGM-connected app feature for Type 2 diabetes patients, unveiled by Abbott and WeightWatchers
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  With the trial’s success, AbbVie prepares Botox for a different aesthetic use
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  Sanofi divests 11 CNS medications to Pharmanovia in a strategic slimming-down move
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  Blackstone’s $250 million investment in ex-Novartis assets pays off
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  BioNTech receives $90 million from CEPI partnership
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  FDA Gives Green Light to GSK’s Innovative Bone Cancer Drug, Validating Billion-Dollar Investment
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  BMS Terminates Two Mid-Stage and Four Early-Stage Clinical Initiatives
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  Scientists successfully grow part-human part-pig kidneys to solve transplant crisis
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  Novo Nordisk’s Wegovy Launch in UK Amid Competition
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  Ahead of the seasonal spike, Pfizer and BioNTech’s Covid vaccine receives FDA greenlight
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  Marketing Authorization Granted for AbbVie’s Migraine Therapy Aquipta
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  Bayer Banks on Kerendia’s Potential in Heart Failure Space
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  Rite Aid to file for bankruptcy to reorganize debt and stop ongoing drug litigation
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  Boston Scientific’s Farapulse System Irregular Heartbeat Treatment 
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  GE HealthCare introduces Vscan Air SL: a handheld ultrasound device for rapid cardiovascular assessment
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  Roche posts encouraging interim study results for a lung cancer treatment
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  Spanish pharmaceutical company Serra Pamies faces EMA production restrictions
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  Hutchmed eyes Drug for autoimmune disease approved in China following phase 3 success
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  Novo Holdings Commits $290 Million to Fuel Innovation and Expand Global Presence of Sangon Biotech
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  Celixir’s Acquisition by Ashington Innovation
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  Two-Year Study Shows Nevro’s High-Frequency Neurostimulation Reduces Diabetic Neuropathy Pain by 80%
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  Patient Death Causes 2seventy Bio’s CD33-Targeted CAR-T Cell Therapy Trial to be Suspended
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  Bristol Myers Squibb Launches Sotyktu Initiative to Provide a ‘Comprehensive Insight’ into Living with Psoriasis
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  Five Things to Know in November 2022
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• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

  $485M settlement for U.S. antitrust case against Sun Pharma’s Ranbaxy
• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

  Pfizer’s RSV vaccine given breakthrough therapy status by FDA
• Editorial Team

  $30 million strategic agreement reached between Sanofi and DarioHealth
• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

  Azeliragon by Cantex to be used in the treatment of inflammatory lung diseases like COVID-19
• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

  Raleigh-based specialty pharma company BDSI To Be Acquired By Collegium Pharma for $604m
• Editorial Team

  China forces insulin price cuts resulting in pullback for global pharma players
• Editorial Team

  Aussie pharma CSL in talks to buy Swiss firm Vifor Pharma for USD 7B
• Editorial Team

  Sanofi to acquire Origimm Biotechnology in a bid to expand vaccine pipeline
• Editorial Team

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• Editorial Team

  Mekonos closes $25M funding round for cell therapy platform
• Editorial Team

  U.S. to buy additional $1B of Merck’s Covid-19 drug
• Editorial Team

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• Editorial Team

  Merck acquires Acceleron Pharma for $11.5B to expand cardiovascular pipeline
• Editorial Team

  Renewed Drug-Pricing Plan by White House Looms over Biotech and Pharma Industry
• Editorial Team

  Gilead, Merck and other big pharmas engaged in illicit “pay-for-delay” deals to retain their lucrative HIV and cholesterol meds supremacy
• Editorial Team

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• Editorial Team

  Amarin goes from conventional to digital marketing for its icosapent ethyl drug VASCEPA
• Editorial Team

  AstraZeneca partners with Imperial’s VaxEquity to bolster its self-amplifying RNA based drugs pipeline
• Editorial Team

  Chinese Pharma Companies Pushing for Global Reach with focus on R&D
• Editorial Team

  Takeda looks to expand vaccine business with traction in Covid-19 and dengue
• Editorial Team

  Takeda Pharmaceutical gets FDA nod for lung cancer drug Exkivity
• Editorial Team

  Purdue Pharma’s Executives to Get Massive $7M Bonus authorized by federal judge
• Editorial Team

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  Xeris Pharmaceuticals gets stockholder nod on Strongbridge Biopharma acquisition
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• Editorial Team

  Pharma will produce over 12B Covid-19 vaccine doses by Dec and 24B by June
• Editorial Team

  McKinsey’s Aamir Malik to join Pfizer as chief business innovation officer with focus on business growth and pipeline
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  Hetero gets approval to make Roche’s tocilizumab in India under the brand name Tocira
• Editorial Team

  Japan investigating if Moderna vaccine contamination caused death of three people
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  Court extends BMS and Pfizer exclusivity over blockbuster Eliquis patent until 2028
• Editorial Team

  Ascendis gets FDA nod on once a week pediatric growth hormone deficiency injection
• Editorial Team

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• Editorial Team

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• Editorial Team

  Pfizer signs agreement to acquire Trillium Therapeutics for $2.26B
• Editorial Team

  Azurity acquires Arbor Pharmaceuticals to form an integrated entity
• Editorial Team

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• Editorial Team

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• Editorial Team

  China based Lynk Pharma raises $50M in series B funding round
• Editorial Team

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• Editorial Team

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• Editorial Team

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• Editorial Team

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  Regeneron is market winner in COVID-19 antibodies with $2.6B sales
• Editorial Team

  Astellas and Minovia partner to develop treatments for mitochondrial cell therapies
• Editorial Team

  Advanz Pharma to pay $140M fine in UK for price hikes on its thyroid drug
• Editorial Team

  Enyo Pharma’s liver disease drus Vonafexor meets its phase 2a clinical study goals
• Editorial Team

  Roche relying on Polivy’s $2B potential to weather biosimilar storm
• Editorial Team

  Amgen to buy Teneobio for $2.5B to further its antibody interests
• Editorial Team

  Pfizer to cough up $345 million to resolve lawsuits over EpiPen price hikes.
• Editorial Team

  BMS’s Opdivo and Yervoy fail to show efficacy and safety in squamous head and neck cancer
• Editorial Team

  GSK gets EU order for its investigational monoclonal COVID-19 antibody therapy
• Editorial Team

  NRx Pharma’s ZYESAMI™ approved for emergency use Covid critical care in Georgia
• Editorial Team

  Kintor and Fosun sign licensing agreement to market Covid-19 drug in India and 28 African nations
• Editorial Team

  FDA adds Guillain-Barre syndrome warning to Johnson & Johnson Covid-19 vaccine
• Editorial Team

  Is Biogen’s Alzheimer’s drug worth $56K? Experts say $8400 and raise questions about efficacy
• Editorial Team

  AstraZeneca and FibroGen hit FDA committee’s safety data firewall for roxadustat
• Editorial Team

  NRx Pharmaceuticals signs deal for clinical trials of Israel’s homegrown Covid-19 vaccine
• Editorial Team

  Pharma manufacturers lawsuits against payers and benefit managers preferred drugs are on FTC’s radar
• Editorial Team

  Roche to lay off 300 to 400 employees in product development jobs
• Editorial Team

  Activist investor Elliott Management asks for new board and CEO to reapply
• Editorial Team

  Centrient Pharmaceuticals doubles its statin production capacity with a new manufacturing facility
• Editorial Team

  Tetra Bio-Pharma’s ARDS-003 combined with antiviral drugs significantly reduces viral replication
• Editorial Team

  Arrowhead and Horizon sign $700M collaboration deal to to Develop RNAi drug for uncontrolled gout
• Editorial Team

  Cusatuzumab back in Argenx’s court as Janssen’s Cilag discontinues partnership
• Editorial Team

  Verona Pharma signs $219 million deal with Nuance Pharma to market Ensifentrine in greater China
• Editorial Team

  In migraine drug battle, Eli Lilly to be sued by Teva after securing patents for Ajovy.
• Editorial Team

  Camber Pharmaceuticals to bring generic Toprol XL to the market
• Editorial Team

  Vertex scores FDA nod for kids’ cystic fibrosis drug Trikafta
• Editorial Team

  Surrounded by controversy, FDA approves Biogen’s Alzheimer’s drug Aduhelm
• Editorial Team

  Clinical-stage Pieris Pharma signs agreement with Genentech for respiratory and ophthalmology therapies
• Editorial Team

  Bristol Myers Squibb’s multiple sclerosis drug Zeposia gets FDA approval for ulcerative colitis
• Editorial Team

  Novo Nordisk resubmits Ozempic for FDA review with new dosing regimen
• Editorial Team

  Amgen’s KRAS drug gets early FDA approval for lung cancer with specific mutation
• Editorial Team

  Myovant Sciences and Pfizer get the FDA nod on MYFEMBREE® to treat heavy menstrual bleeding with once a day treatment
• Editorial Team

  Roche is the biggest R&D spender investing 23.8% of its total sales
• Editorial Team

  NiKang Therapeutics raises $200m in Series C funding for new small molecules in oncology
• Editorial Team

  With the best pipeline in the industry, Lilly’s stock and valuation soar in 2021
• Editorial Team

  Third antibody treatment for early COVID infection approved by the FDA
• Editorial Team

  Singapore based Engine Biosciences raises $43M to grow its digital drug discovery
• Editorial Team

  Bristol-Myers Squibb and Agenus enter a $1.56bn definitive agreement to support cancer programme
• Editorial Team

  Novartis subsidiary Sandoz increasing its antibiotics manufacturing capacity in Europe with $183m investment
• Editorial Team

  Aerpio Pharmaceuticals and Aadi Bioscience merge with continued focus on advancing Fyarrotm
• Editorial Team

  Japan’s MHLW approves AstraZeneca and Moderna Covid-19 vaccines
• Editorial Team

  Janssen files for Covid19 vaccine approval in Japan
• Editorial Team

  With future in sight, GSK sells it stake in respiratory drug firm Innoviva
• Editorial Team

  HBC enters a global innovation alliance with Catalent to develop delayed-release softgel capsules
• Editorial Team

  Incyte agrees to pay $12.6M to settle kickback allegations
• Editorial Team

  Sanofi accused of widespread employee email deletion tied to its 2019 recall of Zantac
• Editorial Team

  Cerecor’s Covid-19 antibody treatment will get fast-track treatment from FDA
• Editorial Team

  Japan-based Nipro Pharma Packaging acquires Croatian manufacturer Piramida
• Editorial Team

  Most life sciences executives say digital delivery of drugs is the future of health
• Editorial Team

  Democrats demand US pharmaceutical companies on their plan to share vaccine IP as pandemic wreaks havoc in India
• Editorial Team

  Pfizer looks to build on its infectious disease expertise with Amplyx acquisition
• Editorial Team

  Potentially tough road for BMS as immuno-oncology pricing war looms
• Editorial Team

  Israel is examining Covid-19 vaccine related cases of myocarditis