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BioSpace is a hub for biotech industry news and careers, offering daily updates on companies, product developments, funding news, and industry trends.

Sarepta Saga Has 'Gone on Too Long' As Competitors Catch Up
NewsFeb 5, 2026

Sarepta Saga Has 'Gone on Too Long' As Competitors Catch Up

Sarepta Therapeutics’ one‑time gene therapy Elevidys, priced at $3.2 million, is under intense scrutiny after three patient deaths in 2025 and a steep 80% stock decline. The company’s three‑year efficacy data failed to reassure analysts, and quarterly sales missed expectations, leaving...

By BioSpace
AbbVie’s I&I Portfolio Sells $30 Billion but Execs Again Underline Other Areas
NewsFeb 4, 2026

AbbVie’s I&I Portfolio Sells $30 Billion but Execs Again Underline Other Areas

AbbVie’s immunology portfolio generated roughly $30 billion in 2025, accounting for nearly half of its $61.1 billion total sales, driven by Skyrizi, Rinvoq and residual Humira revenue. Executives used the earnings call to spotlight under‑appreciated neuroscience and oncology assets, highlighting Parkinson’s drug...

By BioSpace
Amgen Wants MariTide To Change Obesity Paradigm With Longer Dosing Periods
NewsFeb 4, 2026

Amgen Wants MariTide To Change Obesity Paradigm With Longer Dosing Periods

Amgen is positioning its investigational bispecific antibody‑peptide, MariTide, as a differentiated obesity therapy by offering monthly, bimonthly, or quarterly dosing without compromising efficacy. Phase II data revealed an average weight loss of up to 20 % after 52 weeks, and the company...

By BioSpace
GSK Says No to GLP-1s, Prioritizes ‘Downstream Effects’ of Obesity
NewsFeb 4, 2026

GSK Says No to GLP-1s, Prioritizes ‘Downstream Effects’ of Obesity

GSK’s new CEO Luke Miels announced the company will not pursue GLP‑1 obesity drugs, citing a crowded market and pipeline misalignment. Instead, GSK is concentrating on the downstream complications of obesity, particularly liver disease, after acquiring Boston Pharmaceuticals’ efimosfermin alfa...

By BioSpace
Lilly’s GLP-1s Mounjaro, Zepbound Push Revenue up 46% in Q4
NewsFeb 4, 2026

Lilly’s GLP-1s Mounjaro, Zepbound Push Revenue up 46% in Q4

Eli Lilly reported fourth‑quarter revenue of $19.3 billion, driven by a 46 % surge in volume of its GLP‑1 drugs Mounjaro and Zepbound. Earnings per share rose to $7.54, comfortably beating the $6.91 consensus. The two drugs together generated $11.7 billion, lifting the company’s...

By BioSpace
From Awareness to Acceleration: Rare Disease Drug Development Enters a Pivotal Era
NewsFeb 4, 2026

From Awareness to Acceleration: Rare Disease Drug Development Enters a Pivotal Era

Rare disease drug development is poised for rapid expansion, with the market projected to reach $400‑600 billion by the early‑to‑mid 2030s. Recent FDA guidances, including the plausible‑mechanism approval pathway, aim to accelerate cell and gene therapy approvals for ultrarare conditions. Executives...

By BioSpace
2021 Sparked a Banner Year for Biotech IPOs. Where Are They Now?
NewsFeb 4, 2026

2021 Sparked a Banner Year for Biotech IPOs. Where Are They Now?

In 2021 a pandemic‑driven gold rush produced 99 biotech IPOs that raised $15.6 billion, dwarfing the combined proceeds of 2023‑24. The surge created a “logical gap,” with many companies going public before their science was mature, leading to bankruptcies, pivots, and...

By BioSpace
Novo Slides 14% as Early Q4 Results Predict Sales Decline for 2026
NewsFeb 3, 2026

Novo Slides 14% as Early Q4 Results Predict Sales Decline for 2026

Novo Nordisk previewed its early Q4 results, showing a 5% sales decline forecast for 2026 driven by lower U.S. drug prices. The company beat analyst expectations in the quarter, with Ozempic and Wegovy outperforming by 9% and 3% respectively. Shares...

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Pfizer’s Early Metsera Data Leaves Analysts Wanting More
NewsFeb 3, 2026

Pfizer’s Early Metsera Data Leaves Analysts Wanting More

Pfizer disclosed early Phase IIb data for its Metsera‑acquired obesity drug PF’3944, showing a 12.3% average weight loss at week 28 in the 3.2‑mg and 4.8‑mg monthly dosing arms. Analysts noted the placebo‑adjusted loss is roughly 12%, trailing Eli Lilly’s Zepbound 16%...

By BioSpace
Merck Bats Away ‘Modest Growth’ Accusations, Touts Broad Pipeline
NewsFeb 3, 2026

Merck Bats Away ‘Modest Growth’ Accusations, Touts Broad Pipeline

Merck met its 2025 sales guidance, reporting fourth‑quarter revenue of $16.4 billion, slightly above expectations. The company’s HPV vaccine Gardasil saw a 35% global decline, driven by weak demand in China and Japan. CEO Robert Davis countered modest‑growth criticism by highlighting...

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BioNTech’s Multi-Modality Play Outpaces Moderna’s mRNA-Focused Pipeline
NewsFeb 3, 2026

BioNTech’s Multi-Modality Play Outpaces Moderna’s mRNA-Focused Pipeline

BioNTech is outpacing Moderna by expanding beyond mRNA into a multi‑modality oncology pipeline, highlighted by its $3.5 billion pumitamig partnership and several Phase III candidates. Moderna, still anchored to mRNA, has seen COVID‑19 vaccine revenues plunge from $18.4 billion in 2022 to $3.1 billion...

By BioSpace
As Amgen and Lilly Recommit, Puerto Rico Seeks To Regain Manufacturing Momentum
NewsFeb 3, 2026

As Amgen and Lilly Recommit, Puerto Rico Seeks To Regain Manufacturing Momentum

Amgen and Eli Lilly have pledged more than $1.8 billion to expand their Puerto Rico facilities, with Amgen allocating $650 million to its Juncos biologics plant and Lilly committing over $1.2 billion to modernize its Carolina site for oral GLP‑1 production. These investments arrive as...

By BioSpace
Wave To Work Alone on RNA Editor as AATD Picture Becomes Clearer
NewsFeb 2, 2026

Wave To Work Alone on RNA Editor as AATD Picture Becomes Clearer

Wave Life Sciences will continue developing its RNA‑editing candidate WVE‑006 for alpha‑1 antitrypsin deficiency (AATD) after GSK relinquished its stake, aiming for accelerated regulatory feedback by mid‑2026. The AATD market, valued at $2.6 billion today, is projected to reach $6.2 billion by...

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GSK Hands RNA Editor Back to Wave After Underwhelming Early AATD Data
NewsFeb 2, 2026

GSK Hands RNA Editor Back to Wave After Underwhelming Early AATD Data

GSK has returned Wave Life Sciences' RNA‑editing oligonucleotide WVE‑006 after a modest Phase Ib/IIa readout for alpha‑1 antitrypsin deficiency. The September data showed 11.9 µM AAT, slightly below analyst expectations, prompting GSK to refocus on larger indications like COPD. Despite the...

By BioSpace
FDA Warned Corcept of ‘Significant Review Issues’ for Rejected Drug in Early Meetings
NewsFeb 2, 2026

FDA Warned Corcept of ‘Significant Review Issues’ for Rejected Drug in Early Meetings

The FDA issued a complete response letter rejecting Corcept Therapeutics' relacorilant for hypercortisolism, citing significant review issues identified early in the submission process. While the Phase III GRACE trial met its primary endpoint, the agency questioned the hypertension data and warned...

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Opinion: Pricing Transparency Is Coming to the Pharma Industry
NewsFeb 2, 2026

Opinion: Pricing Transparency Is Coming to the Pharma Industry

The article argues that the pharmaceutical sector must abandon its long‑standing secrecy on drug pricing as recent U.S. executive orders intensify pressure for transparency. While companies cite R&D costs and complex payer negotiations, they rarely disclose how individual drug prices...

By BioSpace
Psychedelics Space at a ‘Tipping Point’ as Compass, Definium Gear Up To File for Approval
NewsFeb 2, 2026

Psychedelics Space at a ‘Tipping Point’ as Compass, Definium Gear Up To File for Approval

Compass Pathways and Definium (formerly MindMed) are poised to file FDA applications for their psychedelic therapies—Compass' psilocybin‑based COMP360 for treatment‑resistant depression and Definium's LSD‑based MM120 for anxiety—following late‑stage Phase III readouts. Analysts predict filings by Q3 2025 and potential approvals by 2027,...

By BioSpace
Despite Wide Support for Rare Disease, Voucher Program Caught Up in Senate's ICE Fight
NewsJan 30, 2026

Despite Wide Support for Rare Disease, Voucher Program Caught Up in Senate's ICE Fight

The Senate’s failure to pass the omnibus spending bill left the rare‑pediatric priority review voucher (PRV) program without reauthorization, prompting biotech CEOs to intensify lobbying. Without a renewal, about 200 rare‑disease therapies could lose eligibility, threatening up to $4 billion in...

By BioSpace
FDA’s Multiple Myeloma Guidance Highlights Decade of Success
NewsJan 30, 2026

FDA’s Multiple Myeloma Guidance Highlights Decade of Success

The FDA released draft guidance urging sponsors of multiple myeloma drugs to use minimal residual disease (MRD) negativity as the primary endpoint for accelerated approval, moving beyond traditional overall response rates. The agency defines MRD‑negative as one cancer cell per...

By BioSpace
TrumpRx Delayed Amid Potential Anti-Kickback Concerns
NewsJan 30, 2026

TrumpRx Delayed Amid Potential Anti-Kickback Concerns

The White House postponed the rollout of TrumpRx, the federal direct‑to‑consumer drug marketplace. Officials cite potential violations of the federal anti‑kickback statute as a key factor, prompting HHS to issue a guidance bulletin outlining required safeguards. Major manufacturers including Pfizer,...

By BioSpace
Moderna Teams With Recordati on Rare Disease mRNA Therapy for up to $160M
NewsJan 30, 2026

Moderna Teams With Recordati on Rare Disease mRNA Therapy for up to $160M

Moderna has signed a partnership with Italy’s Recordati to advance mRNA‑3927, a therapy for the rare metabolic disorder propionic acidemia. The agreement provides up to $160 million, including a $50 million upfront payment and milestone fees, with Recordati taking charge of commercialization....

By BioSpace
Sanofi Moves Away From mRNA Flu Vaccine as CEO Projects Confidence
NewsJan 30, 2026

Sanofi Moves Away From mRNA Flu Vaccine as CEO Projects Confidence

Sanofi announced it has deprioritized its SP0237 mRNA‑based seasonal flu vaccine, removing the candidate from near‑term launch plans. The hexavalent shot was in a Phase I/II safety and immunogenicity trial for adults over 50, which remains active but is not recruiting...

By BioSpace
Summit’s Potential Keytruda Rival Gets November FDA Decision Date
NewsJan 30, 2026

Summit’s Potential Keytruda Rival Gets November FDA Decision Date

The U.S. Food and Drug Administration has set a November 14 deadline to rule on Summit Therapeutics’ bispecific antibody ivonescimab, which targets PD‑1 and VEGF in EGFR‑mutant non‑small cell lung cancer. Summit’s Phase III HARMONi trial demonstrated a roughly 50% improvement in...

By BioSpace
Biotech’s Next Chapter: Asset-Centric Deals and Shifting Alpha at JPM 2026
NewsJan 29, 2026

Biotech’s Next Chapter: Asset-Centric Deals and Shifting Alpha at JPM 2026

Biotech is emerging from a multi‑year slump into a new cycle driven by late‑stage, asset‑centric deals, as highlighted at JPM 2026. While headline megadeals were scarce, rumors around Revolution Medicines and Abivax and announced transactions such as Eli Lilly‑Ventyx and GSK‑RAPT underscored...

By BioSpace
AstraZeneca Pledges $15B More in Chinese Investments for Cell Therapies, Radiopharma
NewsJan 29, 2026

AstraZeneca Pledges $15B More in Chinese Investments for Cell Therapies, Radiopharma

AstraZeneca announced a $15 billion investment in its China operations through 2030, aimed at bolstering capabilities in cell therapies and radioconjugates. The funding will support the full drug development chain, from design to manufacturing, and expand existing production sites in Wuxi,...

By BioSpace
Sanofi Suffers Another Sales Dip For 'Gift to Public Health' Vaccines
NewsJan 29, 2026

Sanofi Suffers Another Sales Dip For 'Gift to Public Health' Vaccines

Sanofi reported a 2.5% decline in 2025 vaccine revenue to €2 bn, marking a continued sales dip amid rising U.S. vaccine skepticism. The drop was offset by a 31.5% surge in flu and COVID‑19 vaccine sales, driven by higher virus circulation...

By BioSpace
Lilly Establishes up to $2.7B Repertoire Deal in Second Immune Play of 2026
NewsJan 29, 2026

Lilly Establishes up to $2.7B Repertoire Deal in Second Immune Play of 2026

Eli Lilly has signed a strategic alliance with Repertoire Immune Medicines, providing $85 million upfront and up to $1.84 billion in milestone payments to develop T‑cell‑targeted therapies for autoimmune diseases. The collaboration will use Repertoire’s DECODE platform to pinpoint T‑cell antigen interactions, aiming...

By BioSpace
10 Companies Hiring IT Professionals Now
NewsJan 29, 2026

10 Companies Hiring IT Professionals Now

Biotech firms are aggressively recruiting IT talent as the sector’s digital transformation accelerates. After a mid‑year dip in 2025, job postings rebounded in the last four months and January 2026 listings already surpass December’s total. Ten companies—including AbbVie, Amgen, Lilly...

By BioSpace
REGENXBIO Delay Could Put Denali in Pole Position for Hunter Syndrome Approval
NewsJan 28, 2026

REGENXBIO Delay Could Put Denali in Pole Position for Hunter Syndrome Approval

The FDA placed a clinical hold on REGENXBIO’s RGX‑111 and RGX‑121 after a tumor was found in a five‑year‑old patient potentially linked to the AAV vector. The hold jeopardizes REGENXBIO’s Feb. 8, 2026 PDUFA deadline for its Hunter syndrome gene therapy. Denali...

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J&J’s Darzalex Faspro Notches Another Multiple Myeloma Indication, Pushing Into Frontline
NewsJan 28, 2026

J&J’s Darzalex Faspro Notches Another Multiple Myeloma Indication, Pushing Into Frontline

The FDA approved Johnson & Johnson’s Darzalex Faspro as part of a four‑drug regimen for newly diagnosed multiple myeloma patients who cannot undergo stem cell transplantation. This is the drug’s twelfth overall and fifth frontline indication. Phase III CEPHEUS data showed 52.3%...

By BioSpace
Advanced Therapies Week 2026: ‘Solving for Science’ and Weathering Global Complexity
NewsJan 28, 2026

Advanced Therapies Week 2026: ‘Solving for Science’ and Weathering Global Complexity

Advanced Therapies Week 2026 in San Diego will spotlight the accelerating yet turbulent landscape of cell and gene therapies. New FDA guidance, including the plausible‑mechanism pathway, promises faster approvals, while recent U.S. cuts to mRNA projects and a wave of...

By BioSpace
Cardiff Craters Amid Executive Exits, Mixed Mid-Stage Data
NewsJan 28, 2026

Cardiff Craters Amid Executive Exits, Mixed Mid-Stage Data

Cardiff Oncology announced the departure of its CEO and CFO while releasing mixed Phase II data for its PLK1 inhibitor onvansertib. In the CRDF‑004 trial, the 30 mg dose combined with FOLFIRI + bevacizumab achieved a 72.2% objective response rate and a 62% reduction...

By BioSpace
Roche Makes Obesity Splash, Moderna Cans Vaccine Trials, Sarepta’s New Data, More
NewsJan 28, 2026

Roche Makes Obesity Splash, Moderna Cans Vaccine Trials, Sarepta’s New Data, More

Roche announced that its GLP‑1/GIP candidate CT‑388 achieved a 22.5% average weight loss in a Phase II study and will launch a Phase III trial early this year, pairing the drug with a Zealand Pharma therapy to curb gastrointestinal side effects. Baseline...

By BioSpace
FDA Lifts One of Two Clinical Holds on Intellia’s ATTR Gene Editing Program
NewsJan 27, 2026

FDA Lifts One of Two Clinical Holds on Intellia’s ATTR Gene Editing Program

The U.S. Food and Drug Administration lifted its clinical hold on Intellia Therapeutics' MAGNITUDE‑2 Phase III trial of the CRISPR‑based therapy nex‑z for hereditary transthyretin amyloidosis with polyneuropathy (ATTRv‑PN). The company announced that patient enrollment will resume, prompting a 10 % rise...

By BioSpace
Baseline Debuts To Challenge GLP-1 Giant Lilly in Alcohol Use Disorder
NewsJan 27, 2026

Baseline Debuts To Challenge GLP-1 Giant Lilly in Alcohol Use Disorder

Baseline Therapeutics, a San Francisco biotech, has launched its GLP‑1 analog BT‑001 to treat alcohol use disorder (AUD). The company has secured FDA alignment and will begin two randomized, placebo‑controlled Phase III trials this year. Baseline also plans to expand BT‑001 into...

By BioSpace
Big Pharma Tight-Lipped on Details of API Stockpile Deals
NewsJan 27, 2026

Big Pharma Tight-Lipped on Details of API Stockpile Deals

Pharma giants Bristol Myers Squibb, GSK and Merck have agreed to contribute large quantities of active pharmaceutical ingredients (APIs) to the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) as part of the Trump administration’s supply‑chain resilience push. The deals, sealed at...

By BioSpace
FDA Inspections Should Not Be Source of Stress
NewsJan 27, 2026

FDA Inspections Should Not Be Source of Stress

FDA inspections often trigger frantic, short‑term fixes that hide deeper operational flaws. A reactive approach can lead to costly citations, product recalls, and even multi‑million‑dollar losses, as illustrated by a pump‑contamination incident. Proactive inspection readiness ties asset reliability, documentation, and...

By BioSpace
Sarepta’s DMD Gene Therapy Staves Off Disease Three Years After Treatment
NewsJan 26, 2026

Sarepta’s DMD Gene Therapy Staves Off Disease Three Years After Treatment

Sarepta Therapeutics reported three‑year data from the Phase III EMBARK trial showing that Elevidys, its gene therapy for Duchenne muscular dystrophy (DMD), continues to stabilize disease progression in ambulatory patients. Motor function measures improved, with a 73% slowdown in time‑to‑rise and...

By BioSpace
Merck Backs Off Revolution After Failing To Agree on Price: WSJ
NewsJan 26, 2026

Merck Backs Off Revolution After Failing To Agree on Price: WSJ

Merck and Revolution Medicines ended acquisition talks after failing to agree on a purchase price, with proposals hovering between $28 billion and $32 billion. The biotech’s lead drug, daraxonrasib, has generated strong early‑stage data and earned an FDA priority voucher, making it...

By BioSpace
To Accelerate Rare Disease Progress, Take a Sandbox Approach
NewsJan 26, 2026

To Accelerate Rare Disease Progress, Take a Sandbox Approach

A sandbox framework is proposed to overhaul rare‑disease drug development, allowing regulators, sponsors, patients and academics to collaborate in real time. The model groups therapies into small‑molecule, biologic and complex sandboxes, enabling a continuous IND that spans Phase 1‑3 and eliminates...

By BioSpace
Rare Disease Vouchers Caught in Political Abyss. It Didn’t Have To Be This Way
NewsJan 23, 2026

Rare Disease Vouchers Caught in Political Abyss. It Didn’t Have To Be This Way

The Mikaela Naylon Give Kids a Chance Act, which would re‑authorize the rare pediatric disease priority‑review voucher (PRV) program, is stuck in a $1.2 trillion appropriations bill, jeopardizing its passage despite bipartisan support. The PRV program, created in 2012, grants vouchers...

By BioSpace
BMS Bets $850M on Janux’s Tumor-Activated Drugs, Deepening Cancer Investments
NewsJan 22, 2026

BMS Bets $850M on Janux’s Tumor-Activated Drugs, Deepening Cancer Investments

Bristol Myers Squibb has signed a partnership with San Diego‑based Janux Therapeutics, committing up to $850 million in upfront payments and milestone funding to co‑develop a tumor‑activated immunotherapy. The investigational drug targets an undisclosed solid‑tumor antigen and employs a proprietary masking...

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FDA Sets Feb. 1 Launch Date for PreCheck Pilot To Strengthen Domestic Supply Chain
NewsJan 22, 2026

FDA Sets Feb. 1 Launch Date for PreCheck Pilot To Strengthen Domestic Supply Chain

The FDA will begin accepting applications for its PreCheck pilot on Feb. 1, 2025, with a one‑month window to submit proposals for new domestic drug‑manufacturing facilities. The program, slated for a June 30 selection deadline, offers early regulatory feedback and a streamlined...

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Lexicon Opens Path to $1B+ Opportunity as FDA Greenlights Phase III for Non-Opioid Pill
NewsJan 22, 2026

Lexicon Opens Path to $1B+ Opportunity as FDA Greenlights Phase III for Non-Opioid Pill

Lexicon Pharmaceuticals received FDA clearance to advance its non‑opioid analgesic pilavapadin into Phase III trials for diabetic peripheral neuropathic pain, following a smooth end‑of‑Phase II meeting. The agency raised no additional study requirements and agreed on a 12‑week, placebo‑controlled design using a...

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‘Almost Like a Religion’: Pfizer CEO Slams RFK Jr.’s 'Anti-Science' Vaccine Policies
NewsJan 22, 2026

‘Almost Like a Religion’: Pfizer CEO Slams RFK Jr.’s 'Anti-Science' Vaccine Policies

Pfizer CEO Albert Bourla publicly denounced U.S. Health Secretary Robert F. Kennedy Jr. as "anti‑science" for his vaccine rhetoric, a remark made at the World Economic Forum in Davos. Since Kennedy assumed the HHS role in February 2025, he has questioned...

By BioSpace
From Sound Bites to Signals: Editors Parse Executive and Investor Chatter at JPM
NewsJan 22, 2026

From Sound Bites to Signals: Editors Parse Executive and Investor Chatter at JPM

BioSpace’s Denatured podcast released a post‑JPM episode where senior editor Annalee Armstrong and news editor Dan Samorodnitsky dissect conversations with pharma and biotech executives and investors. Hosted by Jennifer Smith‑Parker, the discussion highlights emerging industry themes and offers forecasts for...

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Increasingly Competitive Job Market Worries, Frustrates Biopharma Professionals
NewsJan 22, 2026

Increasingly Competitive Job Market Worries, Frustrates Biopharma Professionals

BioSpace’s 2026 U.S. Life Sciences Employment Outlook reveals a sharp rise in job‑search activity among biopharma professionals. In the latest survey, 52 % of employed or contract respondents are actively looking, up from 46 % in 2024, while 93 % of the unemployed...

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The New Gold Rush in Brain Science
NewsJan 22, 2026

The New Gold Rush in Brain Science

Venture capitalists are aggressively targeting the brain, with billions flowing into CNS drug development and neurotechnology after breakthroughs in biomarkers, imaging and patient stratification. Big‑pharma deals—Johnson & Johnson’s $14.6 billion acquisition of Intra‑Cellular Therapies and Sanofi’s $470 million purchase of Vigil Neuroscience—signal...

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JPM26: Filling C-Suites, Union Square—And Elevators—With Pink
NewsJan 21, 2026

JPM26: Filling C-Suites, Union Square—And Elevators—With Pink

The Biotech CEO Sisterhood’s pink‑themed gathering at the J.P. Morgan Healthcare Conference drew up to 1,000 participants, underscoring a growing movement to spotlight women executives in biopharma. Since its 2022 launch, the group has expanded to about 350 members and...

By BioSpace