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A daily, curated feed of drug and pharmaceutical news. FDA actions, approvals, recalls, shortages, and the companies behind them.
BioPharma DiveNov 13, 2026
Windward prices $175M IPO to advance China-licensed lung drugs
The Swiss biotech has two prospects it sees as having the potential to outcompete AstraZeneca and Amgen's blockbuster asthma treatment Tezspire.
Read at BioPharma Dive →BioPharma DiveNov 12, 2026
Blackstone bets $1.5B on Pfizer’s obesity drug
The deal will support a sprawling Phase 3 program for a monthly GLP-1 shot Pfizer acquired by winning a bidding war for the drug’s previous owner, Metsera.
Read at BioPharma Dive →STAT — PharmaNov 12, 2026
STAT+: Blackstone backs Pfizer’s bet on monthly obesity treatment
Pfizer spent up to $10 billion to buy Metsera last year. Now, it’s bringing in private equity behemoth Blackstone to help pay for the deal.
Read at STAT — Pharma →
STAT — PharmaNov 12, 2026
STAT+: Will Heidi Overton get to run the FDA?
Does Heidi Overton have the votes ? And how will Dems take on RFK Jr.?
Read at STAT — Pharma →
BioPharma DiveNov 12, 2026
The FDA has over 1k open jobs — and the staffing shortage is hitting pharma
The agency is still recovering from a mass staff exodus last year that left it shorthanded. Here’s what it means for the industry.
Read at BioPharma Dive →STAT — PharmaNov 11, 2026
STAT+: Most-favored nations policy makes drugmakers rethink launches abroad
Drug companies seem to be looking for workarounds to protect their U.S. sales against Trump's "most-favored nations" policy:
Read at STAT — Pharma →
BioPharma DiveNov 11, 2026
Drug price hikes in Germany could push US costs higher, study says
The report comes amid escalating tensions between the U.S. and Germany over drug prices, with several large pharmaceutical companies responding by scaling back investments in the country.
Read at BioPharma Dive →STAT — PharmaNov 11, 2026
STAT+: Cassidy sets key vote on Overton, even as he remains undecided on nominee to lead FDA
Cassidy said he and other GOP lawmakers are undecided on Heidi Overton to lead the FDA.
Read at STAT — Pharma →
STAT — PharmaNov 11, 2026
STAT+: Pharmalittle: We’re reading about Dems eyeing Trump MFN deals, fewer drug launches in Europe, and more
Incoming Democratic chairs of key congressional committees have taken a new step toward investigating most-favored nation drug pricing agreements
Read at STAT — Pharma →
BioPharma DiveNov 11, 2026
AstraZeneca buys vaccine startup; FDA issues GLP-1 safety warning
The deal gives AstraZeneca a simpler way to make conjugate vaccines. Elsewhere, a psychedelic depression drug was submitted to the FDA and an autoimmune disease-focused biotech’s shares collapsed.
Read at BioPharma Dive →BioPharma DiveNov 10, 2026
PepGen soars on promising early data for muscular dystrophy drug
While from a small study, the findings suggest PepGen’s therapy compares favorably to other RNA-based medicines in testing at Novartis and Dyne Therapeutics.
Read at BioPharma Dive →STAT — PharmaNov 10, 2026
STAT+: Former Eli Lilly rep claims she was fired for complaining about marketing of Mounjaro diabetes drug
A former Eli Lilly sales rep filed a lawsuit alleging she was fired after claiming the company was inappropriately promoting its Mounjaro diabetes drug to combat weight loss.
Read at STAT — Pharma →
BioPharma DiveNov 10, 2026
Beam’s base editing therapy for sickle cell hits goal in pivotal trial
The result represents a scientific milestone and positions Beam to submit a first-of-its-kind FDA application as soon as the end of the year.
Read at BioPharma Dive →STAT — PharmaNov 10, 2026
STAT+: GLP-1s are given an FDA warning for rare eye condition risk
The FDA warned that GLP-1 drugs carry a potential risk of a rare but serious eye condition sometimes referred to as an “eye stroke.”
Read at STAT — Pharma →
STAT — PharmaNov 10, 2026
STAT+: Pharmalittle: We’re reading about an approval for novel drug for strokes, a warning for GLP-1 drugs, and more
The FDA approved a novel drug to reduce recurrence of stroke, the agency is warning that GLP-1s carry a potential risk for an eye condition, and more pharma news of…
Read at STAT — Pharma →STAT — PharmaNov 10, 2026
STAT+: Ionis Pharmaceuticals shares plummet after slow rollout of biotech’s triglyceride-lowering drug
Ionis Pharmaceuticals lost more than $1 billion in market value on Monday after the company slashed sales projections for a triglyceride-lowering drug.
Read at STAT — Pharma →
BioPharma DiveNov 9, 2026
Bayer wins FDA nod for a new kind of blood thinner
Sunharbo’s U.S. approval is the first for a “Factor XIa” inhibitor, an anticipated class of medicines seen as a possible step forward in stroke prevention.
Read at BioPharma Dive →STAT — PharmaNov 9, 2026
STAT+: FDA approves novel Bayer drug to reduce recurrence of stroke
Bayer's drug is the first in a novel class of medications designed to prevent blood clots without increasing risk of bleeding.
Read at STAT — Pharma →
STAT — PharmaNov 9, 2026
STAT+: Trump administration removes WuXi AppTec from its Chinese military list
The Trump administration has removed WuXi AppTec, a key partner for the pharma industry, from its list of “Chinese military companies” operating in the U.S.
Read at STAT — Pharma →
BioPharma DiveNov 9, 2026
Vir hepatitis D drug succeeds in first pivotal study
A program that’s survived Vir’s pivot away from infectious disease research hit all of its study objectives and appeared more potent than a rival drug also in late-stage development.
Read at BioPharma Dive →STAT — PharmaNov 8, 2026
STAT+: Why the latest heart drug failures should make us all more skeptical of AI hype
Once again, a hot new technology that was supposed to speed up drug research has fallen flat.
Read at STAT — Pharma →
STAT — PharmaNov 7, 2026
STAT+: BIO joins the legal fight against Medicare pilot that ties drug prices to peer countries
The model is a test of Trump's most-favored nation approach to drug pricing, though its impact is likely to be limited.
Read at STAT — Pharma →
STAT — PharmaNov 7, 2026
STAT+: Failure of Novartis Lp(a) drug raises questions about cardiovascular strategy
Medical mystery at the AHA conference: A Novartis drug lowered a risk marker for cardiovascular disease but did not lower chance of heart attack or stroke.
Read at STAT — Pharma →
STAT — PharmaNov 7, 2026
STAT+: Despite Novo drug’s failure, cardiologists say they will still pursue anti-inflammatories
“These results, the fact that they're negative, does not invalidate that inflammation plays a very important role in cardiovascular disease."
Read at STAT — Pharma →
BioPharma DiveNov 6, 2026
Novartis reveals cancer cases possibly linked to gene therapy Zolgensma
The occurrence of cancer in nine recipients — two of which involved evidence that a viral delivery tool integrated into patient DNA — could raise new questions for the gene therapy field.
Read at BioPharma Dive →STAT — PharmaNov 6, 2026
STAT+: Up and down the ladder: The latest comings and goings
From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
Read at STAT — Pharma →
STAT — PharmaNov 6, 2026
STAT+: New tumor cases show common gene therapy tool can come with risk
New cases show AAV gene therapies like Zolgensma carry tumor risks, raising key concerns for SMA patients and gene therapy researchers in general.
Read at STAT — Pharma →
STAT — PharmaNov 6, 2026
STAT+: Amgen’s Repatha linked to fewer heart attacks
Pithy intro text about the biopharma milieu. Novartis cites more tumor reports after Zolgensma Novartis has disclosed seven previously unreported cases of tumors in children who received Zolgensma, its gene therapy…
Read at STAT — Pharma →
STAT — PharmaNov 6, 2026
STAT+: Pharmalittle: We’re reading about a Novartis gene therapy, faster U.K. drug reviews, and more
Novartis acknowledged seven instances of tumors being found in children who were treated with Zolgensma for spinal muscular atrophy
Read at STAT — Pharma →BioPharma DiveNov 6, 2026
Lilly, Hims reach GLP-1 deal; Alnylam sales chief to step down
The deal is part of a course change for Hims, which had previously sold knockoff GLP-1 drugs. Elsewhere, a medicine Servier recently acquired failed a key trial and Ultragenyx announced staff cuts.
Read at BioPharma Dive →FDA — Press ReleasesNov 5, 2026
FDA Grants Accelerated Approval to a New Treatment for Head and Neck Squamous Cell Carcinoma
The U.S. Food and Drug Administration today granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherap
Read at FDA — Press Releases →STAT — PharmaNov 5, 2026
STAT+: Pharma’s trade group spent heavily on search ads to sway public opinion
PhRMA spent an estimated $59 million on search advertising over a recent seven-year period to influence how Americans view prescription drug costs.
Read at STAT — Pharma →
BioPharma DiveNov 5, 2026
Medicare will cut billions from 340B, expand site-neutral payments in 2027
Regulators finalized a rule Wednesday that would slash payments for drugs in the controversial 340B program and equalize some payments between care sites. Hospitals railed against the rule.
Read at BioPharma Dive →STAT — PharmaNov 5, 2026
STAT+: Novartis cites cases of previously unknown tumors possibly tied to its SMA gene therapy
Novartis has acknowledged seven previously unknown instances in which tumors were found in children who were treated with its spinal muscular atrophy therapy, Zolgensma.
Read at STAT — Pharma →
BioPharma DiveNov 5, 2026
At ASH, drugmakers to showcase early data for three-pronged cancer therapies
J&J and AbbVie are among the companies advancing “trispecific” antibodies that could become another step forward in treatment for multiple myeloma.
Read at BioPharma Dive →STAT — PharmaNov 4, 2026
STAT+: Pharma critic Bernie Sanders is set to hold major sway over FDA funding bill
Sanders could use his role in crafting the FDA funding bill to push for reforms.
Read at STAT — Pharma →
BioPharma DiveNov 4, 2026
Sanofi stops development of Nurix-partnered immune drug
The decision sparked a sell-off in Nurix shares as well as analyst debate about the prospects of drugs designed to degrade a tough-to-reach protein called STAT6.
Read at BioPharma Dive →BioPharma DiveNov 4, 2026
Novo gets much-needed lift as Wegovy pill tops Wall Street forecasts
The drug’s third-quarter sales numbers came in well above consensus estimates, widening Novo’s early edge over Eli Lilly in the latest battleground for weight loss medicines.
Read at BioPharma Dive →BioPharma DiveNov 4, 2026
Biopharma likely to climb higher after ‘blue wave,’ analysts say
Historical data suggests the sector outperforms after midterm elections. And Democrats, newly in control of Congress, have “bigger fish to fry” than drug pricing, analysts said.
Read at BioPharma Dive →STAT — PharmaNov 4, 2026
STAT+: Ultragenyx cuts staff after another study fails
Ultragenyx announced that it's laying off about 20% of its staff as it ends development of two rare disease drugs.
Read at STAT — Pharma →
STAT — PharmaNov 3, 2026
STAT+: Servier’s $1.55 billion muscular dystrophy drug fails first major test
Servier reports a surprise setback for a drug being tested for a form of muscular dystrophy that lacks treatment.
Read at STAT — Pharma →
BioPharma DiveNov 3, 2026
Vertex, ahead of FDA decision, calms fears surrounding kidney drug
On a conference call, executives expressed conviction in the coming launch of an IgA nephropathy medicine viewed by Wall Street investors as important to Vertex’s future.
Read at BioPharma Dive →STAT — PharmaNov 3, 2026
STAT+: Who will get the first psychedelic approved?
The biotech Compass Pathways has been seen as one of the frontrunners in the race to get the first psychedelic drug approved. But it could be a tight race, with a non-profit…
Read at STAT — Pharma →
STAT — PharmaNov 3, 2026
STAT+: Pharmalittle: We’re reading about a generic HIV prevention shot, Lonza buying U.S. facilities, and more
The FDA gave tentative approval to Dr. Reddy’s Laboratories to make a generic version of a groundbreaking HIV prevention medicine
Read at STAT — Pharma →BioPharma DiveNov 3, 2026
Medicare Part D premiums are spiking 50% on average next year, KFF finds
The health policy think tank urged seniors to shop carefully for prescription drug coverage during Medicare open enrollment, given skyrocketing premiums and wide variance in costs between plans.
Read at BioPharma Dive →BioPharma DiveNov 2, 2026
Karyopharm, deep in debt, to sell itself in bankruptcy
The parent of cell therapy maker Gamida Cell will be the lead bidder in a court-supervised auction of Karyopharm, which recently cut a forbearance deal to push off debt payments.
Read at BioPharma Dive →STAT — PharmaNov 2, 2026
STAT+: FDA OKs generic HIV prevention shot, widening access for lower-income countries
The FDA has approved a generic HIV prevention shot, a key step in widening access for dozens of lower-income countries.
Read at STAT — Pharma →
STAT — PharmaNov 2, 2026
STAT+: Pharmalittle: We’re reading about payments to Russian middlemen, a possible Dupixent rival, and more
Four big drugmakers allegedly paid tens of millions of dollars to middlemen to supply lifesaving drugs to Russian government entities
Read at STAT — Pharma →BioPharma DiveNov 2, 2026
Earnings roundup: AstraZeneca’s cost cuts, Alnylam’s slump and Regeneron’s resilience
AstraZeneca will “redeploy resources” through a new restructuring program. Meanwhile, Alnylam shares sold off on fears surrounding a top drug and investors rewarded Regeneron for a record quarter.
Read at BioPharma Dive →FDA — Press ReleasesNov 2, 2026
FDA Provides Clarity to Support Cell and Gene Therapy Development and Quality
The U.S. Food and Drug Administration today issued final guidance for manufacturers of cellular and gene therapy (CGT) products to implement a comprehensive, science- and risk-based plan for making sure their products meet potency standards.
Read at FDA — Press Releases →FDA — Press ReleasesOct 30, 2026
FDA Approves First Plasmid DNA-based Immunotherapy for Adults with Recurrent Respiratory Papillomatosis
The U.S. Food and Drug Administration today granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for treatment of adults with recurrent respiratory papillomatosis (RRP).
Read at FDA — Press Releases →BioPharma DiveOct 30, 2026
This week in charts: ESMO’s winners and losers
The latest installment in BioPharma Dive’s visualization-focused series looks at Wall Street’s response to a trio of closely watched presentations at a top meeting for cancer drugs.
Read at BioPharma Dive →STAT — PharmaOct 30, 2026
STAT+: Up and down the ladder: The latest comings and goings
From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
Read at STAT — Pharma →STAT — PharmaOct 30, 2026
STAT+: Pharmalittle: We’re reading about AstraZeneca cost-cutting, Sun Pharma facility problems, and more
AstraZeneca has launched a three-year cost-cutting program that aims to slice off $1.5 billion a year, with the savings reinvested in R&D.
Read at STAT — Pharma →BioPharma DiveOct 30, 2026
With Setara, the team behind Actio opens its second act
The fledgling startup has $90 million to develop a pipeline of drugs, led by a Charcot-Marie-Tooth disease medicine, that Actio was working on when Jazz Pharmaeuticals bought its lead epilepsy program.
Read at BioPharma Dive →BioPharma DiveOct 30, 2026
Aspen raises a $141M IPO in pursuit of a cell therapy for Parkinson’s
The San Diego biotechnology startup is one of several firms working on a cutting-edge technique with the potential to slow or even halt the neurodegenerative condition.
Read at BioPharma Dive →BioPharma DiveOct 29, 2026
Labor Department finalizes sweeping PBM disclosure rule
Starting in 2027, the controversial drug middlemen will have to share a broad swath of fee and compensation data with self-funded employer clients. Employers cheered the rule, while PBMs slammed it as government overreach.
Read at BioPharma Dive →BioPharma DiveOct 29, 2026
Genmab soars to record highs after cancer drug succeeds in key trial
The drugmaker’s market value swelled by more than $7 billion on findings suggesting a recently-acquired medicine could become a new treatment standard for a form of head and neck cancer.
Read at BioPharma Dive →BioPharma DiveOct 29, 2026
HHS to allow compounders to make 6 unapproved peptides
RFK Jr. has given notice that the agency won’t take enforcement action on six peptides that controversially won a contested recommendation from outside advisers to the FDA in July.
Read at BioPharma Dive →STAT — PharmaOct 29, 2026
STAT+: El-Sayed claps back at RFK Jr., and FDA’s ‘enforcement discretion’ on peptides
Abdul El-Sayed, the Democratic Senate candidate in Michigan, pushes back against the RFK Jr.'s claims, and the new FDA policy around peptides.
Read at STAT — Pharma →
Sources: reputable US pharmaceutical news outlets and FDA press releases, via their public feeds. Links open the publisher's site and carry no endorsement. Pillstats is a referrer, not a republisher.